North London Cancer Research Network

Transcription

1 North London Cancer Research Network Annual Report - Dr Masuma Harrison Research Network Manager 8/6/ Aderonke Adebiyi Research Network Manager Dr James Lyddiard Senior Research Network Manager 8/6/ 8/6/ Dr John Bridgewater Clinical Lead 8/6/

2 CONTENTS List of Abbreviations... 4 Acknowledgements... Executive Summary... 6 Table : Research Profile in North London... 7 Section : Organisation and Development of the Network... 9 Figure : North London Cancer Research Network Structure Chart... Challenges... Children s Cancer and Leukaemia Community... Interaction with Cancer Service Network... Peer Review... 4 Interaction with Other Research Infrastructure... Financial Statement... 6 Section : Portfolio and Overview Table : Total Annual Figure : Total Annual Clinical Studies (CSG) Performance Figure : Local Research Network Overall Yearly by CSG (Improved CSG -)... 9 Performance against forecast recruitment -... Table : Summary of Forecast Activity... Delivery of NIHR CRN adopted commercial -... Balance of Portfolio... Table 4: Table of trust and network portfolio, recruitment of participants benchmarked to national performance -... Trust Performance Figure 4: Annual Participant by Trust ( -, -, -)... 9 Barnet & Chase Farm Hospitals NHS Trust (BCFH)... Figure A: Summary of Portfolio Activity & Key Achievements -... Table A: Patient Referral from BCFH to other NLCRN trusts -... Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH)... Figure B: Summary of Portfolio Activity & Key Achievements -... Table B: Patient Referral from GOSH to other NLCRN trusts -... North Middlesex University Hospital NHS Trust (NMH)... 4 Figure C: Summary of Portfolio Activity & Key Achievements Table C: Patient Referral from NMH to other NLCRN trusts -... The Princess Alexandra Hospital NHS Trust (PAH)... 6 Figure D: Summary of Portfolio Activity & Key Achievements Table D: Patient Referral from PAH to other NLCRN trusts Royal Free London NHS Foundation Trust (RFH)... 8 Figure E: Summary of Portfolio Activity & Key Achievements Table E: Patient Referral from RFH to other NLCRN trust University College London Hospitals NHS Foundation Trust (UCLH)... 4 Figure F: Summary of Portfolio Activity & Key Achievements Table F: Patient Referral from UCLH to other NLCRN trusts The Whittington Hospital NHS Trust (WH)... 4 Figure G: Summary of Portfolio Activity & Key Achievements Table G: Patient Referral from WH to other NLCRN trusts Follow up Non-portfolio activity... 44

3 Section : Workforce... 4 Infrastructure... 4 Figure 6: Centralised NLCRN Team Organogram Table 6: Whole Time Equivalents across the Whole Research Network Workforce Development Additional Local Initiatives Section 4: Patient and Public Involvement (PPI)... Social Media and PPI: The NLCRN Twitter Feed... Section : Other Initiatives... Future Plans... 4 Appendices... 6 Appendix : NLCRN Portfolio Activity... 6 Table 7: Portfolio and recruitment for - (compared against forecast recruitment)... 6 Appendix : Delivery of NIHR Clinical Research Network adopted Commercial Studies Table 8A: Studies which closed to recruitment nationally during the - reporting year Table 8B: Remaining open to recruitment nationally during the - reporting year Appendix : Follow-up... 7 Table 9: Patients follow-up numbers... 7 Appendix 4: Executive Summary of Workforce Development Annual Report for London & SE England... 7

4 List of Abbreviations ASCO BCFH CCLG CCRN CEL CLRN CR UK CRF CRN CSG CSP CTA CTP CTU GCP GOSH HR ICS IRAS IM LCRN NCRI NCRN NELCRN NIHR NLCRN NMH NSSG PAH PI PIC POSCUs PPI PTCs QA R&D RCF RCT RFH RNM SOP SSI T&E UCL UCL ECMC UCLH UCLP WH WTE American Society of Clinical Oncology Barnet and Chase Farm Hospitals NHS Trust Children s Cancer and Leukaemia Comprehensive Clinical Research Network Central and East London Comprehensive Local Research Network Cancer Research UK Clinical Research Facility Cancer Research Network Clinical Studies Coordinated System for Gaining NHS Permission Clinical Trials Agreement Clinical Trials Practitioner Clinical Trials Unit Good Clinical Practice Great Ormond Street Hospital for Children NHS Foundation Trust Human Resources Integrated Cancer System Integrated Research Application System Industry Manager Local Clinical Research Network National Cancer Research Institute National Cancer Research Network North East London Cancer Research Network National Institute for Health Research North London Cancer Research Network North Middlesex University Hospital NHS Trust Network Site Specific The Princess Alexandra Hospital NHS Trust Principal Investigator Patient Identifier Centre Paediatric Oncology Shared Care Units Patient and Public Involvement Principal Treatment Centres Quality Assurance Research and Development Research Capability Funding Controlled Trial Royal Free London NHS Foundation Trust Research Network Manager Standard Operating Procedures Site Specific Information Training and Education University College London UCL Experimental Cancer Medicine Centre University College London Hospitals NHS Foundation Trust University College London Partners The Whittington Hospital NHS Trust Whole Time Equivalent

5 Acknowledgements We would like to thank everyone who has contributed to the annual report, all the research staff and clinicians that work across North London and all the patients that have taken part in trials. It has been another successful year made possible by everyone s contribution. Thanks also to Guilherme Schroeter (Guy), our QA Manager, for all his hard-work and efforts to get this report completed on time. James, Ade and Guy

6 Executive Summary The North London cancer research Network is one of Cancer research networks which covers the whole of the NHS in England. The NLCRN is hosted by University College Hospital Foundation trust and serves a population of.6 million. In / the NLCRN supported a portfolio of 7. The year of - has been a challenging year for the NLCRN. The Network, the North East London Cancer Network (NELCRN) and the Central and East London Comprehensive Local Research Network (CEL CLRN) have been working together in preparation for the pilot commencing in April. We hope that this collaboration will help to inform the transition due to start in April 4. CEL CLRN provided additional funding to the NLCRN to provide service support cost funding for new cancer this year. This funding in addition to CEL CLRN contingency for a number of key posts has augmented the trials support provided by the core budget of 6, with RCF of 9,7. The NLCRN core budget and RCF together supported 8.84 WTE, additionally CLRN funding and other sources contributed to a total workforce of 8.8 WTE. Trial recruitment has increased in / we were successful in recruiting 8 patients demonstrating a year on year increase this represents an almost 6% increase in overall recruitment compared with / we have done particularly well in non-rct S this year where we have seen almost 4% increase in recruitment despite changes and variability on the NCRN portfolios. Portfolio s that performed extremely well with significant increases in activity in / were breast, upper-gi, prostate and CCLG. Areas that require development are the lung and melanoma portfolios. Activity has been varied across the sites with marked increase at UCLH, PAH and GOSH whilst NMH, BH and RFH have seen a decrease in activity. This has been due in part to staff turnover and the closure of key trials. WH recruitment has remained stable. The year has seen almost a doubling in the number of commercial trials that closed to recruitment, trials closed this year compared to only 8 last year. The number of open trials has increased, being 47 as compared with 7 in the previous year. The Harmonisation project, which set tight timelines on approval of these projects started in October and has had mixed success; however, the project is still in its early stages. The centralised team are crucial to the success of the wider network, both operationally and strategically and continue to provide direct contact and support for study set-up, quality assurance, industry trials and workforce development. Overall the NLCRN remains a strong, well organised and effective organisation in delivering clinical trials recruitment. We would hope this is maintained indeed improved in the newer infrastructure of the LCRN.

7 Table : Research Profile in North London Size Section # Indicator Network value Minimum th Percentile National median and range Median 7th Percentile Network Population (NCRN) (millions) Maximum Cancer incidence (NCRN) of new cancer patients treated/year (CWT data - ) Funding 4 NCRN funding (Core + Research and Capability Funding) ( ) 79,48. 4,9. 6,9. 677,7. 8,47.,,6. Funding Management Staffing Portfolio Financial returns submitted on time (Y/N) Y All returns submitted on time 6 Spend to approved NCRN Core budget 6, 7 Spend to approved Research and Capability Funding budget 9,7 8 Total wte NCRN funded staff.9 9 Total wte CLRN funded staff.8 Total wte staff funded from RCF in -.9 Total wte other staff supporting NIHR CRN cancer portfolio in of NIHR CRN non-commercial cancer portfolio open LRN Self-reported of NIHR commercial cancer portfolio open Proportion of total NIHR national cancer portfolio open and recruiting of NIHR open to recruitment with no recruitment 4 LRN Self-reported 6 Return rate for expressions of interest for NIHR CRN commercial Portfolio Delivery 8 Response rate for Company Identified Site Reviews for NIHR CRN commercial HLO Total number of participants recruited (NIHR cancer portfolio )

8 Quality # Indicator Workforce Development Patient & Public Involvement Network value Minimum th Percentile National median and range Median 7th Percentile Maximum Proportion of cancer patients recruited (NIHR cancer portfolio ) (as % of NCRN cancer incidence) Proportion of cancer patients recruited to intervention (as % of NCRN cancer incidence) Proportion of cancer patients recruited to RCTs (as % of NCRN cancer incidence) of other (non-patient) participants recruited to NIHR CRN cancer portfolio Total number of participants recruited to NIHR CRN commercial cancer Proportion of cancer patients recruited to NIHR CRN commercial cancer Total number of NIHR CRN commercial cancer sites in the local research network that participated in which closed nationally in HLO A Proportion of NIHR CRN commercial cancer study sites within the LRN delivering to time & target in - 67% % 4% % 64% 7% 7 Proportion of attaining forecast recruitment % LRN Self-reported 8 of recruiting in - that did not have a forecast 7 LRN Self-reported Proportion of Cancer Research Network Peer Review Measures 9 met -A-/4/ = % SA Compliance (No IV Published) (CQuINs) of NCRI Clinical Studies Members of Chief Investigators for NIHR CRN portfolio 8 LRN Self-reported Attendance at regional Workforce Development meetings LRN Self-reported of CLG members (Full and Associate members) Proportion of survey respondents from across the network reporting having discussed research (Q7)

9 Organisation and Development of the Network Section : Organisation and Development of the Network The North London Cancer Research Network was established in and serves a population of.6 million people. The Network is comprised of seven acute Trusts, University College London Hospital (UCLH), Royal Free Hospital (RFH), Whittington Hospital (WH), North Middlesex Hospital (NMH), Barnet and Chase Farm Hospitals (BCFH), Great Ormond Street Hospital (GOSH) and Princess Alexandra Hospital (PAH). Three hospitals (UCLH, RFH and NMH) provide radiotherapy services for their populations and surrounding areas. Our Network Constitution has a yearly review, the current version is NLCRN Constitution v4. 7/8/. Locally there is also an Experimental Cancer Medicine Centre based at UCL as well as an NIHR supported Clinical Research Facility. Six of the seven trusts within the network are contained within the Central and East London Comprehensive Research Network with PAH being located within the Essex & Herts Comprehensive Research Network. The NLCRN coordinates cancer clinical research and facilitates study set-up and delivery across all seven sites. The NLCRN has seen a steady increase in recruitment across an increasingly balanced portfolio of trials since being established in. The core management team and clinical lead have a comprehensive oversight of activity within the network, and meet regularly to discuss staffing, activity, portfolio balance and other relevant topics. Our Steering Committee meets times a year to discuss recruitment and current developments. These meetings are attended by the core management team, a representative from each Trust and two consumer representatives. The joint management structure that exists between the NLCRN and the UCL ECMC has allowed for more efficient use of staffing resources across both organisations. This has facilitated the co-development of processes and the use of a single system for data capture and analysis on EDGE. The joint structure has also opened up other benefits for the research network such as provision of our office space by the University and access to University meeting rooms for local use and also for the wider pan-london meetings. The staffing model is mixed with a centralised core team which is led by Dr John Bridgewater (Clinical Lead) and Dr James Lydiard (Senior RNM). The Industry Manager Christine Menzies works collaboratively across the South West London Cancer Research Network and the NLCRN. Aderonke Adebiyi started in post in September as Lead Nurse/RNM, job sharing the RNM post with Masuma Harrison. As Lead Nurse for the network, Aderonke leads on the development of the centralised Data Manager and Clinical Trial Practitioner roles as well as providing support to sites and acting as the educational link for the wider Network. The cancer research network workforce is multidisciplinary with all staff working as integrated teams at various sites irrespective of funding sources. There has been no significant change in the make-up of the team. There were 8.84WTE centrally appointed team and.4wte appointed directly by Trusts in a devolved manner. Staff turnover has been a challenge this year. This in turn has affected recruitment in certain tumour groups, which has meant that we have had to put some trials on-hold until staffing numbers have improved (for full details see section Workforce).The structure and relationships are depicted in Figure.

10 Organisation and Development of the Network Key areas of development this year have focused on collaborative working with the North East London (NEL) network due to the changes within the provider network, working with UCL Partners and working with the CELCLRN LCRN Pilot. Underperformance in the commercial portfolio has been highlighted in previous years. The emphasis this year has been placed on ensuring that deliver to time and target. The Industry Manager has been working closely with research teams, Principal Investigators and R&D Personnel to improve the set-up timelines and feasibility process; to assist with the Harmonisation project for NIHR commercially adopted to gain NHS permissions; to actively performance manage recruitment targets in order to ensure that targets are met (see section : Portfolio and Overview -). Cancer services for children and young adults in the network are provided by UCLH and GOSH Principle Treatment Centre (PTCS). The NLCRN has been working with both UCLH and GOSH to facilitate the set-up of designated Paediatric Oncology Shared Care Units (POSCUs) via shared care agreements within North London and we are working closely with Investigators and research teams to maintain and expand the workforce wherever possible. One of our key challenges in / has been assisting with the set-up of the UKALL trial at the two PTCs and ensuring that appropriate shared care agreements are developed and utilised.

11 Figure : North London Cancer Research Network Structure Chart UCLP Medical Director Professor Organisation and Development Kathy Pritchard-Jones of the Network Dr John Bridgewater - NLCRN Clinical Lead (.WTE) Dr James Lyddiard Legend Network Post Other Post Site Senior Research Network Manager (.WTE) Head of Trials UCLH (.7WTE) Christine Menzies Network Industry Manager (.4WTE) Aderonke Adebiyi NLCRN Manager (.WTE) & Lead Nurse (.WTE) Masuma Harrison NLCRN & UCL ECMC Manager (.WTE) Emma Hainsworth CR UK Lead Nurse (.9WTE) x Research Associate - Rachel Taylor (.WTE) Guy Schroeter - Network QA Manager (.WTE) Vacant - Senior Administrator & Research Governance Manager (.WTE) UCLH Clinical Research Facility.WTE Cohort Manager,.WTE Research Associate x Clinical Trials Practitioners Azmina Verjee (WH) (.8WTE), Vacant (BCF) (.WTE),Vacant (NMH) X Clinical Data Managers - Gayle D Souza (.WTE), Gita Parmar (.WTE), Vacant (.WTE) Emma Douch - Clinical Trials Assistant (.WTE). WTE Lead Research Nurse;. WTE Clinical Portfolio Manager; 7.6 WTE Research Nurses;. WTE Clinical Trials Coordinator;. WTE Data Managers;. WTE Lab Manager;. WTE Lab Technician;. WTE Administrator Barnet and Chase Farm Hospitals Great Ormond Street Hospital North Middlesex Hospital Princess Alexandra Hospitals Whittington Hospital Royal Free Hospital University College London Hospital.8WTE Clinical Trial Practitioner;.WTE Data Manager Karen Howe (.WTE) Research Manager/ Lead Nurse Devolved network staff:.6wte Data Manager.WTE Research Nurses;.WTE Data Managers;.WTE Research Associate;.WTE Admin Devolved network staff:.wte Data Manager 4.WTE Research Nurses;.7WTE Admin Epping:.WTE Research Nurses Devolved network staff: Harlow:.WTE x Research Nurses,.8WTE Clin Trials Practitioner;.WTE Data Manager.WTE Research Nurse Angela McCadden (.WTE), Research Manager; Olu Omotayo (.WTE) Portfolio Manager Devolved network staff:.wte x Research Nurses,.8WTE Clin Trials Practitioner.6WTE Research Nurses; 6.WTE Clin Trial Practitioner;.WTE Data Managers;.WTE Admin Aryana Chopra (.WTE); Zoe Wood (.WTE) Oncology Research Managers Devolved network staff:.wte x Research Nurses,.WTE Data Manager.WTE Team Leaders; 4.8WTE Research Nurses;.WTE Clin Trial Practitioner;.4WTE Radiographer;.6WTE Data Managers;.WTE Admin Lydia Ward/Laura Favero (.7WTE), Jo Hargroves (.4WTE) Haematology Research Managers Devolved network staff:.wte x Clinical Trials Practitioner.7WTE Research Nurses;.WTE Clin Trials Practitioners;.WTE Data Manager;.WTE Admin

12 Organisation and Development of the Network Challenges One of the challenges faced by NLCRN this year has been the adoption of a collaborative network approach to both planning and delivering of the portfolio by providing joint research reports (North London and North East London) to all pathway boards in London Cancer giving a detailed overview of recruitment activity and the delivery of to time and target. The Harmonisation project pilot has been challenging this year. Two weekly meetings were instigated by the Networks Industry Manager to improve on communication for all involved in the pilot. R&D approval timelines continue to be a challenge for the research network. Network staff attend weekly R&D meetings at UCLH where updates are provided on the status of governance checks, costing and contracts. This has resulted in a significant improvement in the communication with R&D. The workforce had a period with a considerable number of vacancies due to high staff turnover which in turn impacted on recruitment. Children s Cancer and Leukaemia Community The service for younger patients in North London is complex with under thirteen s generally being treated at Great Ormond Street Hospital for Children NHS Foundation trust (GOSH) and over thirteen s being treated within the Teenage and Young Adult service at UCLH. This year the NLCRN has been focusing on the opening of the UKALL study and has been working closely with both sites, as well as ensuring that comprehensive support is available for efficient study set up at the shared care centres, where maintenance therapy using IMPs is delivered. Over the past year we have had a series of meetings with UCLH and GOSH aimed at formalising the relationship for study conduct between each Principle Treatment Centre (PTC) and its associated Paediatric Oncology Shared Care Units (POSCUs) via a shared care agreement. Both PTCs have opened UKALL to recruitment and agreed the wording of the agreements this year. The process of sign-off for agreements is being facilitated by the Network. The NLCRN office has also assisted with the set-up of more routine study arrangements including input from the Industry Manager in the joint set-up of a commercial study across UCLH and GOSH. We have worked to enable GOSH to collect data on EDGE which would give us uniform network-wide informatics on cancer clinical trial activity for the area. Additionally, in response to a number of issues raised at GOSH, the Quality Assurance (QA) Manager has been involved in supporting the teams to develop preventative action plans to ensure study protocol compliance and quality delivery.

13 Organisation and Development of the Network Interaction with Cancer Service Network Following the review of cancer Networks in London, the remit of the Clinical Cancer Networks for North and North East London have been merged to form an Integrated Cancer System from London Cancer. This organisation is led by UCL Partners (UCLP) which was formed from an alliance of all the Trusts within North and North East London. The Tumour Advisory Boards were replaced this year by Tumour specific Pathway Boards led by a Clinical Pathway Director with the remit of service configuration and management of developing service across the single Network. Each Pathway Board has a research representative tasked with highlighting and promoting research across the network. The aim of London Cancer is to improve outcomes and experience for cancer patients in North Central and North East London by providing a whole systems approach for patient care. This new way of working will strengthen the support for promoting clinical trial participation across the whole network and foster closer working between the NLCRN with and the NELCRN. We have adopted a collaborative network approach to both planning and delivery of the portfolio by providing joint research reports (NLCRN & NELCRN) which provide a detailed overview of recruitment activity according to time and target. Underperforming are also highlighted and one of our aims this year has been to work with the research teams to identify key barriers to recruitment and to provide a visual overview of the availability and diversity of trials across the NLCRN and NELCRN. We have also locally developed the national trial maps to span both networks in order to facilitate discussions. In, UCLP commissioned a new initiative, known as the Harmonisation Pilot, to streamline and reduce the time taken to receive NHS Permissions for commercial across all UCLP NHS organisations. The initiative is currently being piloted (due to end May ). Four Permission Centres (each with responsibility for the approval of specific clinical areas) conduct the approval of commercial on behalf of all participant sites across UCLP. The initiative has introduced standard, consistent costs and contracts as well as unified submission requirements. In addition, coordinated approvals for pharmacy, imaging and other support services have been introduced. UCLH is of the 4 permission centres, alongside Barts Health, GOSH and NoClor, and is responsible for the approval of a large and complex portfolio, including all cancer and neuroscience trials. Cancer clinical trials are becoming increasingly complex and are targeting smaller, more closely defined disease subgroups. This has inevitably led to an increasing number of trials in order to maximise opportunities for patients. Achieving objectives such as completing trials on time and to target; recruitment of the first patient into a study within days on approval on SIV date and increasing the number of research participants has become more dependent on collaborative network-wide working. The network has encouraged research teams to collaborate on where one site acts as a Patient Identifier Centre (PIC) in order to improve intra-network referral. This has worked well for the breast study SUPREMO where patients were identified at WH and referred to UCLH for treatment and then followed-up back at WH. This has also worked well for the head and neck study PET- NECK with collaboration between NMH and BCFH.

14 Organisation and Development of the Network Peer Review The research network self-assessed in the - year and deemed itself compliant with all measures. Previous recommendations have been consistently reviewed every year, such as the NLCRN organogram which has been updated to reflect how the centralised team supports the network sites. Please refer to Table : Research Profile in North London, item 9 for the score according to CQuINs. The Network PPI Lead worked and led the PPI Day on the 8 th April (see section 4: Patient & Public Involvement). The work programme and the annual report were agreed by the Chair of the Cancer Research Network single group and the Chair of the Network Board. The Service Level Agreements with all Trusts are in place. Steering Committee meetings were held over the year.

15 Organisation and Development of the Network Interaction with Other Research Infrastructure During the year / the NLCRN has continued to support the merged management of the NLCRN and the UCL ECMC. The UCL ECMC continues to fund an additional.wte post providing further opportunities for collaborative working with the network. This includes the set-up of and collection of data on EDGE. The management team continue to host monthly ECMC management meetings and quarterly ECMC board meetings. The NLCRN ensures that Network staff work cohesively with Trust-based research teams so that all staff and Investigators working on NIHR portfolio research work in a consistent and collaborative manner. The North London Cancer Research Network continues to work closely with Central and East London CLRN which covers six of the seven hospitals within the network. Princess Alexandra Hospital falls under Essex and Hertfordshire CLRN and this year we have strived to build relationships with the EHCLRN via a series of meetings looking at the set-up and approval of via their feasibility process. Interaction with other local topic research networks has been hosted by the CEL CLRN and attended by network managers. Our main focus this year has been discussions around the local implications of the NIHR governance review, transition arrangements and the development of the CEL LCRN pilot. There have been regular meetings with the CEL CLRN team for the development of the pilot and the Senior RNM has been involved in informing some of the detailed plans as a member of the pilot board. The Senior RNM or RNM attends the Pan-London and South of England network regional meetings. These are held at the NLCRN offices in central London, providing an easily and accessible location for participants. These meetings provide an essential forum for discussion of common topics and, this year they have focused on the Governance review. Training continues to be collaborative with the other cancer research networks across Pan- London and SE England (see section Workforce Development). The joint appointment of the Industry Manager with the South West London Cancer Research Network has helped to improve the feasibility process and highlighted the importance of recruiting to target for commercial. The Industry Manager has also been involved in developing key training for staff working within CEL CLRN aimed to improve the feasibility, performance and costing of commercial in relation to the UCLP harmonisation project. Due to the Cancer Network provider functions being managed through London Cancer as well as the development of the CEL CLRN LCRN Pilot, the North London and North East London networks have worked more closely together. We have collaborated by jointly providing data on key metrics and developing joint portfolio maps for Pathway Boards. This has been possible by attending regular meetings with London Cancer and NEL Cancer Research Network. We have developed strong links with the NIHR CRF based at UCLH. All NIHR trials that are run through the CRF are set up by the NLCRN office with additional support for the set-up of commercial from the Industry Manager and the Early Phase Cancer Portfolio

16 Organisation and Development of the Network Manager. The CRF focuses on early phase trials and the links with the CRF are extremely well defined through the relationship with the UCL ECMC. Financial Statement The core budget for the North London Cancer Research Network for - was 6, with Research Capability Funding of 9,7. The expenditure for the same period was the full amount of 79,48. The NLCRN was able to utilise in full all of the core and RCF financial allocation in -. There remains the on-going issue of managing the network within a flat budget as the on-going cost pressures of incremental drift cannot be accounted for within core funding. This is particularly relevant as the more senior posts (band 6 and above) tend to be relatively stable with staff staying in post for an average of plus years. The on-going burden of accounting for incremental drift without annual increases means that to-date.wte of substantive posts (a decrease of.7wte from /) have been reduced from the core budget. This will continue to impact in the coming years. We would estimate that over the next months we will need to lose the equivalent of a further.wte of posts due to this process which will have inevitable consequences for activity/quality levels. Further to the core budget, during / the NLCRN managed.m of CLRN funding related to service support costs across our member organisations. This approach has allowed ring fenced of funding for cancer trials could be appropriately directed to support the large NIHR portfolio of cancer trials.

17 Portfolio and Overview - Section : Portfolio and Overview - Table : Total Annual - Year Patients Other recruits Total participants RCT non-rct Incidence % of cancer incidence % of cancer incidence Other RCT Other non- RCT Definitions: Patient - recruits with cancer or a pre-malignancy. Contributes to the delivery of NCRN national targets for the proportion of cancer patients recruited to the portfolio as well as NIHR Clinical Research Network High Level Objectives. Other participant - recruits without cancer or a pre-malignancy (includes case controls, recruits to screening/prevention/diagnostic ). Contributes to delivery of NIHR Clinical Research Network High Level Objectives. All participants - includes all recruits regardless of disease status. Contributes to delivery of NIHR Clinical Research Network High Level Objectives.

18 Portfolio and Overview - Overall recruitment for - was.7% higher than /, representing significant growth. The total number of participants in reached the second highest level ever achieved in over a decade, at 8 subjects. 87 more participants were recruited to in - compared to - (see Figure : RCT versus Non-RCT - ). During - there were 9 recruiting, of which were RCTs and 96 were non-rcts. In -, 8.% of the network s cancer incidence was recruited into RCTs, compared to.% in the previous year. In addition, 4.% of cancer incidence was recruited into non-rct in -, compared to.% in -. This unprecedentedly high level reflects the achievement of a key objective to increase recruitment into non-rct. Figure : RCT versus Non-RCT - Other non-rct Other RCT non-rct RCT In total, there were 6 fewer recruits to RCTs in - compared to the previous year, whereas there were 4 more recruits to non-rcts. The decline in recruits to RCTs was anticipated since no new high-recruiting RCTs were due to open in -. Given that a small reduction in RCT activity was foreseen, there was a concerted and successful drive to increase recruitment within the non-rct portfolio. Non-RCT recruitment this year is the highest ever achieved for the network, exceeding the one thousand mark (,64). High recruiting non-rct included Tumour Angiogenesis (a validation of outcome measures study in colorectal cancer), the CNS 4 Functional Imaging of Tumours study in childhood cancer, and several genetics such as SEARCH, BOCS (formerly named FBCS) in breast cancer, CORGI and NSCCG in colorectal cancer, UKGPCS in prostate cancer, and NSHLG in lymphoma.

19 Portfolio and Overview - Going forward, it will be important for the network to identify appropriate RCTs to replace those which close, in order to sustain activity and maintain balance across the different tumour groups. For example, in -4 FOCUS4 will open within the colorectal tumour group which is expected to be a high recruiting RCT and also contribute to the non-rct activity. As the clinical trials landscape shifts towards biomarker-driven stratified (personalised medicine) designs, the network s RCT versus non-rct recruitment profile is likely to evolve further. Clinical Studies (CSG) Performance - The year of - has been excellent for recruitment overall, with particular emphasis on Breast, Prostrate, CCLG and Upper GI portfolios, all showing a significant increase in recruitment. Figure : Local Research Network Overall Yearly by CSG (Improved CSG -) 4 7/8 8/9 Breast CCLG Colorectal Prostate Upper GI 9/ / / / Predicted recruitment within the breast portfolio was achieved this year, with the highest number of participants being recruited into this portfolio. Import High, the radiotherapy breast study and BOCS, a non-randomised study made up the majority of the total recruitment. We would expect to see recruitment to breast increase further in the coming year due to the opening of Targit B. into CCLG dropped last year with a total recruitment of 8 patients; however, recruitment this year has more than doubled with a total recruitment of 7 patients. This is in part due to reaching or exceeding their forecast target. There was a slight dip in recruitment in the colorectal group last year but this has picked up again in -, this can be attributed to the Tumour Angiogenesis and Corgi that contributed significantly in the total recruitment. It is anticipated that with new key

20 Portfolio and Overview - (FOCUS-4) opening in the coming year, recruitment will continue to increase. Activity to the prostate portfolio continues to improve with a high proportion of patients being recruited into the Non-RCT study PROMIS (prostate MRI imaging Study) and several focused in diagnostic. to the Upper GI Portfolio has increased further this year although it was anticipated that recruitment would fall due to the closure of a number of in /. However, a number of trials including the BOOST trial for Barretts Oesophagus have performed strongly to compensate for this. A steady increase in the head and neck cancer portfolio has been seen this year, although recruitment figures are still relatively small in comparison to some other tumour types as only a few trusts within our network specialise in this area. The LEONIDAS study has been the major recruiter for head and neck, with over patients registered since opening at the beginning of the reporting year, accounting for over half the total recruitment in this tumour group. to renal trials has seen a substantial decrease due to the two highest performing trials closing to recruitment in January this year. The Sorce and Transource accounted for over 8% of the total renal recruitment, thus their closure has a significant impact on the figures. A slight decrease was also seen in haematology trials, which can be attributed mainly to the closure of AML6 in May. There are currently a large number of trials in set-up in the haematology portfolio, so it is anticipated that this will increase in -4. As predicted last year, the opening of the new locally developed CanTalk study along with the Biliary Tract Cancer Quality of Life Validation study has resulted in increased activity within the psychosocial area of research. As this was previously a severely underrepresented area of the portfolio, hopes are high for the future despite current recruitment figures still being relatively low. Further work is needed to ensure that the CanTalk trial will successfully complete in /4. A number of trials were opened this year across multiple sites within the network. For example Streamline L and Streamline C, imaging with high potential recruitment in lung and colorectal respectively have been set-up at three different sites. This has contributed to the increase seen in colorectal figures; however the closure of the extremely successful Lung-BOOST in - has resulted in the impact of opening Streamline L being less noticeable. Also currently in set-up is FOCUS-4, an umbrella trial for testing novel agents for colorectal cancer, due to be running across five sites within the network and predicted to be available to a large patient population. It is therefore hoped that the impact of this trial will be noticeable in next years figures. The report presents data on all NIHR CRN that the network supports; this includes which are jointly supported and resourced by other parts of NIHR CRN.

21 Portfolio and Overview - Performance against forecast recruitment - Table below summarises the recruitment forecast against actual recruitment for -. Appendix shows the full list of portfolio and recruitment for - (compared against forecast recruitment). Forecasting for - was conducted using the UKCRN database data, predicted annual accrual captured on the SSI, previous recruitment -, anticipated opening date and study closure date. More than half of the portfolio which had forecast figures performed well (classified as green or amber) with just under a quarter of the portfolio underperforming against targets. Details for reasons are highlighted in Table 4. Table : Summary of Forecast Activity Total forecast recruitment for - 8 Total actual patient recruitment - 8 Total number of recruitment 8 predicted of Studies Reason for Performance Recruited at least 9% of forecast Recruited to 66-89% of forecast Recruited less than 6% of forecast Of the 7, 9 were interventional RCTs. The RCT which exceeded the expected recruitment included STAMPEDE, RATHL, The LEONIDAS study, SCOT and IMPORT HIGH. One of the contributing factors to the success of such as STAMPEDE and SCOT are that they are open at sites across the network. Non-RCT which performed well include Tumour Angiogenesis, BOCS (FBCS), CORGI and PROMIS. The majority of these were breast, lymphoma, haematology and sarcoma. Some that were close to target include ESSG, PACIFICO and REACT. Compared to -, a smaller proportion of were below target recruitment compared to those that met target. There are many factors contributing to this performance figure, with % of these closing during the reporting period and being put on hold during set-up due to staff shortages at a number of sites; unfortunately this is a factor we are unable to control. However, an area the NLCRN have been focusing on is working closely with R&D to assist in streamlining the study approval process through new projects like the Harmonisation Project.

22 Portfolio and Overview - Delivery of NIHR CRN adopted commercial - During /, the Industry Manager (IM) was focusing mainly on the feasibility process and the performance management of the open trials. She worked closely with CIs, PIs and research teams to make sure the feasibility process was as robust as possible and set up a detailed spread sheet to track dates of receipt and deadlines for responses for both Expressions of Interest and Network checks on pre-selected sites in line with national requirements. In terms of performance management of open commercial trials, the IM has been in close contact on a regular basis with teams across NLCRN who were underperforming according to time and target and has worked with the PIs and their research staff to suggest ways to make sure their trials are delivered on time. The IM worked very closely with personnel from the CEL CLRN and Liaison Officers from the UCLH R&D Permission Centre to help ensure a smooth and quick approval process for the commercial trials through the UCL-P Harmonisation process. The IM met with the external consultant who lead the harmonisation project to discuss suggested time points to be captured and also in line with the new process, set-up and ran three training courses for research staff across CEL CLRN on topics ranging from The Feasibility process for network trials to Performance Managing trials. The year has seen almost a doubling in the number of commercial trials that closed to recruitment, trials closed this year compared to only 8 last year. The performance has also improved dramatically, from % to 67% completing to time and target with the best performing areas being haematology, lymphoma, colorectal, renal and gynaecological cancer. Five trials did not manage to achieve target last year, the reasons are detailed in appendix. The volume of commercial trials has significantly increased with the number of open trials being 47 as compared with 7 in the previous year. This increase in activity is across the range of tumour types. Lymphoma and lung were two specific areas where extra support from the NLCRN was required in order to make sure the trials were delivered to time and target. As detailed under the Additional Initiatives, the IM assembled a newsletter summarising all the open commercial lymphoma trials and key contacts which was circulated to all the relevant staff across NLCRN to try and increase referrals for underperforming trials. Within the lung portfolio, the IM initiated the set-up of a specialised group of commercially active consultants within the network to encourage a more open and transparent feasibility process. The objective of the group is to ensure that the most appropriate site(s) are nominated for selection in the knowledge that the other sites within the network would refer patients to a single site. Following on from /, UCLH as a green shoot site for prostate cancer is now recruiting well to NCRN TERRAIN. During / Barnet and Chase Farm were put forward as a green shoot site for prostate and bladder observational trials but as yet no appropriate have been established at site. On-going active management of the commercial portfolio by the IM has significantly contributed to the improvement in this priority area.

23 Portfolio and Overview - Balance of Portfolio table Table 4: Table of trust and network portfolio, recruitment of participants benchmarked to national performance - Local Research Network totals compared to NCRN median CSG Indicator Network total NCRN lowest NCRN RANGE (graphic) NCRN highest 8 Bladder Cancer Intervention 9 Brain Tumour Intervention 8 Observation Breast Cancer Intervention Observation Colorectal Cancer Gynaecological Cancer Intervention Observation Intervention Observation

24 Portfolio and Overview - CSG Indicator Network total NCRN lowest NCRN RANGE (graphic) NCRN highest CSG 9 Haematological Intervention 4 9 Oncology Observation Head and Neck Cancer Lung Cancer Lymphoma Melanoma Prostate Cancer Intervention Observation Intervention Observation Intervention Observation Intervention Observation Intervention

25 Portfolio and Overview - CSG CSG Renal Cancer Sarcoma Testis Cancer Upper Gastro- Intestinal Cancer Indicator NCRN RANGE NCRN highest Indicator Network total NCRN lowest (graphic) CSG 8 8 Observation Intervention 6 Observation Intervention 7 48 Observation 4 Intervention 8 6 Observation Intervention 6 6 Observation 97 9

26 Portfolio and Overview - CSG Indicator All Clinical Studies s Intervention Observation Biomarkers and Imaging Intervention Observation Children's Cancer and Leukaemia Intervention Observation Palliative & Supportive Care Intervention Observation Primary Care Observation Psychosocial Oncology Network total Intervention NCRN lowest NCRN RANGE (graphic) NCRN highest

27 Portfolio and Overview - CSG Indicator Observation Network total Intervention Observation Teenage and Young Adults Observation Intervention Observation NCRN highest 9 Grand total NCRN RANGE (graphic) Radiotherapy NCRN lowest Key - 7th Percentile Individual Network Total NCRN Median

28 Portfolio and Overview - Table 4 summarises the performance of the NLCRN in relation to the median (and range) of across the NLCRN divided by CSG. The overall total number of open to recruitment during / increased slightly compared to the previous year, from 6 to 7 (7 interventional plus observational ). This is higher than the NCRN median, with the highest network having a total of 9. Looking at the number of patients recruited to interventional trials, 77 patients were entered this year, this figure was again higher than the NCRN median, the highest number entered for any network was 47. Unfortunately the number of patients locally entered to observational was less than the NCRN median (98 patients were entered within NLCRN despite the fact that there were more observational open compared to the rest of the country), a review of performance to this area is needed for the forthcoming year. Within many key areas the portfolio does very well with respect to recruitment of the CSGs. The following groups all recruited more than the national median to the interventional : bladder, brain, gynaecological, haematology, head & neck, lung, lymphoma, melanoma, prostate, sarcoma, testis and upper GI, children s cancer and leukaemia and psychosocial oncology. Within this group, brain, haematology, lymphoma, prostate, sarcoma, upper GI and children s cancer and leukaemia performed particularly well. Looking in detail at the observational however only 8 CSGs recruited more than the NCRN median: colorectal, breast, gynaecological, prostate, upper GI, palliative & supportive care, children s cancer and leukaemia and teenage and young adults. Tumour groups that have potential for improvement through extending activity to observational trials include: haematological oncology (only 9 patients were entered to trials compared to the highest network entering 6 patients to trials); head & neck cancer, lung cancer, all clinical group, psychosocial oncology and radiotherapy (only patients entered compared to the patients in the highest recruiting network).the NLCRN is actively engaged with PI s and relevant trusts to develop and maximise the portfolio in these areas to improve on future activity. Looking at both interventional and observational together, only a very small number of CSGs managed to perform well across both these types of trials: children s cancer and leukaemia, gynaecological, prostate, and upper GI cancers with the best performance. The Network s centralised staff work closely with the Trusts to facilitate study set up prioritising those that could impact on recruitment.

29 Portfolio and Overview - Trust Performance - The NLCRN plays a key role in performance management of trials across the network and has an in-depth overview of the portfolio. The Senior Trials Administrator and Clinical Trials Assistant are responsible for the local set-up of all NIHR and work closely with the research teams to identify appropriate. Studies are promoted locally via research reports which are disease specific and provide detailed information on recruitment targets. Figure 4 summarises achievements by Trust and shows that UCLH contributes approximately % of the annual participation. Figure 4: Annual Participant by Trust (-, - and -) 8 6 Other: non-rct Other: RCT Patients: non-rct 4 Patients: RCT BCFH GP GOSH NMH PAH RFH UCLH WH / / / / / / / / / / / / / / / / / / / / / / / /

30 Portfolio and Overview - Barnet and Chase Farm Hospitals NHS Trust Figure A: Barnet and Chase Farm Hospitals NHS Trust recruitment of participants for / by CSG Lymphoma % Lung % Prostate % Head and Neck 7% Breast 44% Haematology 4% Colorectal 4% Figure A: Summary of Portfolio Activity & Key Achievements - The breast portfolio remained the strongest area for recruitment in -, representing 44% of recruitment at BCFH. Lung accounted for % of recruitment, having increased from % the previous year. Lymphoma and Colorectal trial recruitment have also increased from the previous year. Haematology trials showed the greatest reduction in activity, falling from % to 4% of the portfolio. Overall, recruitment increased slightly from the previous year, rising from to 4 patients despite gaps in staffing through the year. The BCFH team have opened around new portfolio trials since April and one of the highlights of the year for the team has been working on trials in new areas such as prostate cancer. The STAMPEDE prostate study and the OPTIMA breast study have been the Trusts top recruiting trials this year, since opening to recruitment in. The research department spent 6 months of the last year with only part time Clinical Trials Practitioner and months without a Data Manager. This had a serious impact on its ability to support clinicians to recruit patients into the newly opened trials. This particularly hampered recruitment to Haematology trials. to the ET lung study was hampered by the inability to give chemotherapy to lung cancer patients at Chase Farm Hospital. Chase Farm patients were referred to NMH or Barnet Hospital if they wanted to take part on the ET study. The NLCRN lead nurse has continued to work with the CTP and Data Manager at site throughout the year providing support. As clinical support is provided from the Mount Vernon Network, there is additional NIHR activity that takes place at site but contributes towards Mount Vernon activity.

31 Portfolio and Overview - Table A: Patient Referral from BCFH to other NLCRN Trusts - Referring Hospital Barnet & Chase Farm Hospitals NHS Trust Site Patient Referred to North Middlesex Hospital Royal Free Hospital University College London Hospital TOTAL Patient Total 6 Examples of most common trial referrals STAMPEDE, RADICALS TRANSORCE, SORCE PICTURE, PROTEC 4 Focus for -4 The NLCRN aims to recruit another CTP to work with existing staff at BCFH and there will also be an addition of another data manager to join the team, enabling all new trials to be covered and ultimately to increase recruitment into trials at both hospitals. Several consultants have expressed an interest in opening commercial ; this will create a new challenge for the team and will also provide patients with even more opportunities to enter clinical trials. The R&D Director will be appointing an R&D manager which should help to process governance checks for new trials and amendments even more smoothly and quickly. A closer working relationship with the treatment centres NMH and MV to recruit patients into suitable trials is another objective, again giving more options to patients.

32 Portfolio and Overview - Great Ormond Street Hospital for Children NHS Foundation Trust Figure B: Great Ormond Street Hospital for Children NHS Foundation Trust recruitment of participants for / by CSG Haematological % Colorectal % Not Specified % Prostate % Sarcoma % Brain % Children's Cancer and Leukaemia % Breast 4% Figure B: Summary of Portfolio Activity & Key Achievements - The current portfolio at GOSH is balanced between interventional and observational. Compared to last year, recruitment had an increase of slightly over %. This is due to the CNS 4 and BOCS. Activity has also increased within the colorectal group, this is attributed to the CORGI study and 7% of activity is related to genetic in the family history practice. The most significant reduction in activity was seen in the haematology group and is predominantly due to the closure of four. has also slightly decreased in the sarcoma study STS 6, the only sarcoma study open at GOSH. A new area of activity during this period includes recruitment into the brain study AIP. GOSH in conjunction with the NLCRN IM have successfully opened two commercially adopted early phase and the number of commercially adopted is likely to increase over the next few years. During - the team was not up to core establishment for much of the year with the absence of team lead for 6 months. The team has extended collaboration with the GOSH Clinical Research Facility and the trial data backlog has been significantly reduced. The NLCRN have been in discussions with GOSH about the implementation of EDGE version and the QA Manager has also been in close contact with the team at GOSH offering QA support to the team.

33 Portfolio and Overview - Table B: Patient Referral from GOSH to other NLCRN Trusts - Referring Hospital Great Ormond Street Hospital for Children NHS Foundation Trust Patient referred to University College London Hospital TOTAL Patient Total 4 Examples of most common trial referrals BRIGHTLIGHT 4 Focus for -4 One of the main focuses will be to develop a closer relationship with the Clinical Research Facility in order to increase research nurse resource capacity. The relationship with the NLCRN team in regards to trial set-up, the trial management system EDGE and implementation of quality systems will also be placed. The introduction of an internal GCP audit system conducted by the NLCRN QA Manager will deliver high quality research to GOSH. A new translational research team will increase the recruitment to biological. The team also plans to secure long term funding for clinical trials team core posts beyond 4.

34 Portfolio and Overview - ) North Middlesex University Hospital NHS Trust Figure C: North Middlesex University Hospital NHS Trust recruitment of participants for / by CSG Lung % Prostate 9% Upper GI % Haematological % Breast % Colorectal % Figure C: Summary of Portfolio Activity & Key Achievements - NMH overall recruitment has reduced slightly compared to last year. However, some groups have performed significantly well and the activity has increased in the lung group mainly due to the NCRN48 ARCHER study. The colorectal group has also seen an increase in activity, partly due to the SCOT study. Breast, haematology and prostate groups have also had a slight increase in activity. The most significant reduction was seen in the upper GI and can be attributed to the study closure of BOSS making an impact in the overall recruitment which decreased by nearly 9%. The NMH team faced some challenges this year, such as funding and maintaining contracts in a changing and difficult financial climate; time to target and managing the Trust and R&D expectations of oncology research nurses role. However, the team has successfully met and exceeded the target for the ARCHER study. In - the team celebrated the Departments th Anniversary. The NLCRN Lead Research Nurse has actively supported the team and the QA Manager has implemented new SOPs in the cancer team. A Network CTP has also worked in the NMH team over -.

35 Portfolio and Overview - Table C: Patient Referral from NMH to other NLCRN Trusts - Referring Hospital North Middlesex University Hospital NHS Trust Patient referred to Royal Free Hospital University College London Hospital TOTAL Patient Total 7 Examples of most common trial referrals TRANSORCE BRIGHTLIGHT, meoc 9 Focus for -4 The NMH has just taken delivery of a brand new Linac. This will allow a focus on opening radiotherapy clinical trials to further increase recruitment of local patients in this very specialised field. There are plans to engage Consultants who may not have previously been active within research. The Research Department will be participating in International Nurses Day, presenting a stand in the hospital on Friday th May to highlight their roles as oncology research nurses. In order to raise awareness across the Trust and amongst the local community, they plan on hosting a stand in the hospital on 'International Clinical Trials' day. They will be conducting a Chocolate Trial to explain the concept of inclusion/exclusion criteria and randomisation associated with participating within a clinical trial.

36 Portfolio and Overview - The Princess Alexandra Hospital NHS Trust Figure D: The Princess Alexandra Hospital NHS Trust recruitment of participants for / by CSG Lung Lymphoma % % Colorectal 7% Prostate % Upper GI % Breast 68% Figure D: Summary of Portfolio Activity & Key Achievements - St Margaret s Hospital (Epping) Only breast are conducted at St Margaret s Hospital and recruitment into has remained stable in this portfolio. The non-rct study SEARCH had another year with significant activity. There was an increase in recruitment to commercial in Epping, predominantly due to the NCRN 4EVER UK and NCRN46 TDM. This is a result of a closer working relationship between the Trust research team and the Network Industry Manager. Princess Alexandra Hospital (Harlow) In comparison to last year, there have been no significant changes in the overall recruitment in Harlow. There are a variety of colorectal ; the SCOT trial continues to be the highest colorectal recruiter. The newly opened ARISTOTLE is actively screening patients and is anticipated to recruit a large number of patients. Prostate have observed a significant increase in patient recruitment in their three in comparison to last year. A slight decrease was being seen in the upper-gi and lung portfolio, mainly due to study closures side and changes in the ET study eligibility criteria. The commercial lymphoma study NCRN46 GALLIUM has also been successful in recruiting more patients this year. The NLCRN has provided Lead Nurse support and the QA Manager worked to improve the quality systems in both Trusts.

37 Portfolio and Overview - Table D: Patient Referral from PAH to other NLCRN Trusts - Referring Hospital Princess Alexandra Hospital NHS Trust Patient referred to University College London Hospitals TOTAL Patient Total 7 Examples of most common trial referrals ICON8, INTERLACE 7 Focus -4 Princess Alexandra and St Margaret s Hospitals have a portfolio in expansion. Colorectal continues to be the group recruiting the largest number of patients in PAH. Plans for the future include opening the FOCUS 4, BACCHUS and STREAMLINE C. Expanding the portfolio of NIHR commercially adopted is also an area of continued development for the NLCRN across both sites.

38 Portfolio and Overview - Royal Free Hospital NHS Foundation Trust Figure E: Royal Free Hospital NHS Foundation Trust recruitment of participants for / by CSG Upper GI 4% Breast 4% Renal 7% Colorectal 4% Lymphoma 8% Melanoma % Radiotherapy % Psychosocial % Haematological % Prostate % Figure E: Summary of Portfolio Activity & Key Achievements - The team continues to be led by the Portfolio Manager and Lead Research Nurse. The overall recruitment in - has decreased by around 6% in comparison to last year. However, some areas have shown relevant improvement in the recruitment numbers; the upper-gi group had a significant increase predominantly due to the CUP ONE trial and a couple of commercial. Melanoma and haematology also improved their activity over the year, the commercial melanoma NCRN4 MELABIS and NCRN4 BRAF+MEK and the haematology AML-7 and the commercial NCRN6 are responsible for this welcome increase. Activity in the breast study has been maintained. The remaining areas observed a decrease in activity, renal and lymphoma showing the most significant reduction. to the renal study TRANSORCE had reduced by nearly % and the renal trial COSAK has been closed. The lymphoma study NSHLG had also recruited fewer patients this year. Staff turnover has been a particular challenge within the study team. Research Nurses and Clinical Trials Practitioners working at full capacity alongside the implementation of the UCLP Harmonisation process has been somewhat challenging in the pilot phase but gradually the process is being better understood and the benefits reaped. The difficulty in recruiting to vacant posts was evident and is now being considered at Board level. The Harmonisation project has added a new dimension to this as study set up is out pacing the ability to recruit suitable staff. Despite this, the team open trials within 8- weeks of TFC discussion, and managed to work at capacity when the unit had prolonged resources issues and therefore, current staff number was expanded to approximately members. The nursing and CTP

39 Portfolio and Overview - team have implemented a new strategy to cross cover in the face of sustained staffing shortages. The NLCRN has provided data management and QA support over -. The quality system has been improved with the implementation of new SOPs. Table E: Patient Referral from RFH to other NLCRN Trusts - Referring Hospital Royal Free London NHS Foundation Trust Patient referred to University College London Hospitals TOTAL Patient Total 4 Examples of most common trial referrals HYMN, TRISST 4 Focus -4 The Royal Free team aims to explore further revenue streams to increase the data management resource available in the Oncology and Haematology Clinical Trials Unit to ensure that trial set-up/approval timelines are kept within 8- weeks from TFC discussions. One of the new objectives is streamlining the processing of commercial clinical trials payments and invoicing. The team will work with R&D to implement a mechanism for better allocation of clinical trial funding to service support departments. A closer working relationship within the NLCRN, R&D, UCL-P colleagues, pharmaceutical companies, service support departments to deliver clinical trials that will benefit patients is also expected. The team is seeing an increasing number of novel intravenous IMP's for trial. They plan to work closely with the chemotherapy day unit to achieve the best way of supporting administration of these and to support trial patients treated in the off-site infusion centre at Finchley Memorial Hospital.

40 Portfolio and Overview - University College London Hospital NHS Foundation Trust Children's Cancer and Leukaemia % Figure F: University College London Hospital NHS Foundation Trust recruitment of participants for / by CSG All Clinical s % Teenage and Young Adults Testis % Upper GI 7% Sarcoma % % Bladder Brain % % Psychosocial % Prostate 6% Breast 4% Colorectal % Lymphoma 8% Gynaecological % Palliative & Supportive Care % Lung % Head and Neck 4% Haematological 9% Figure F: Summary of Portfolio Activity & Key Achievements - UCLH provides the central hub for trial activity as part of the joint Cancer Centre and as such contributes the largest proportion of patients and has the most diverse trials portfolio. There is a close working relationship between the NLCRN office and the Cancer Clinical Trials Unit at UCLH which is facilitated by the joint role of the Head of Cancer Trials who is also Senior Network Manager for the NLCRN. Overall NIHR activity has increased by nearly 4% compared to last year, with participants being recruited into trials this year. into upper-gi and uro-surgery has doubled, with a significant increase seen in recruitment into NCRN-adopted trials. Activity within sarcoma trials is significantly lower than last year, which is explained by the fewer number of trials that opened within the tumour group. With a further 6 sarcoma in set-up, an increase in trial recruitment is anticipated over the coming year. The increase in the lung portfolio this year is a big achievement in oncology as this was one of the areas we aimed to develop during -. Additionally, the team is keen to increase further activity in head & neck trials as this portfolio has improved since -. This year the NIHR commercial portfolio has increased substantially and there are a number of further new trials in the pipeline, working with the NLCRN IM in feasibility and set-up ensuring that important NIHR metrics are met. The paediatric research team continues to work with young patients and their families across all tumour types, covering NIHR commercial and academic. Although the portfolio

41 Portfolio and Overview - has seen the closure of the national leukaemia study UKALL, it has continued to grow following the opening of UKALL and a new NIHR commercial trial. The past year has seen an expansion of the haematology research portfolio, particularly in CLL. Although there has been a decrease in recruitment to NIHR following closure of a particular lymphoma retrospective observational study, there has been a rise in commercial activity. The most significant achievement this year has been the appointment of Dr Rakesh Popat to lead in developing our portfolio of early phase across haematology. Since his appointment, new Phase / trials have opened, with several more in the pipeline. To ensure a transparent and balanced consideration for academic leadership, scientific competitiveness and patient need, we are currently piloting a Trial Prioritisation Tool to score new trials. The transplant portfolio has also expanded and recruitment has commenced into the first gene therapy study with a second gene therapy study due to open in April. The management teams have been fortunate in securing funding for all staff on fixed term contracts this year. Additionally, funding from the Al-Fayed Charitable Foundation, the Central and East London Comprehensive Local Research Network (CEL CLRN) and a fourth haematology data manager from a commercial company have been secured. The team continue to work closely with the Research and Development (R&D) department to open with minimal delays. This year has seen significant changes taking place in the R&D department requiring the CCTU to adapt the current internal processes. The NLCRN has provided extensive Data Management and QA support in -. A great number of SOPs have been created and GCP audits have been conducted. Table F: Patient Referral from UCLH to other NLCRN Trusts - Referring Hospital University College London NHS Foundation Trust Patient referred to Royal Free London Hospital Patient Total TOTAL Examples of most common trial referrals NCRN4 Focus for -4 The UCLH team plans to continue to reduce study set up times to open within the nationally defined timelines and expand the trial portfolio. A continuous improvement of the haematology trials tracker monitoring progress against planned recruitment target is expected (with adoption in oncology if appropriate); also maintaining in high levels of GCP and SOP compliance, with the ultimate aim of achieving per cent for both. The team aims to make use of the new database to capture intelligent data and use this to improve set-up times and recruitment to time and target. Ensuring funding for existing staff and development of the team as required by seeking all available funding streams is also vital as well as continuing to develop the team leader roles to enhance the support available to the team. Facilitating personal and professional development and providing portfolio management will also take place over -4.

42 Portfolio and Overview - The Whittington Hospital NHS Trust Figure G: The Whittington Hospital NHS Trust recruitment of participants for / by CSG Prostate % Psychosocial % Lung 4% Breast 8% Haematological 7% Colorectal 6% Figure G: Summary of Portfolio Activity & Key Achievements - The overall recruitment has remained stable. However, activity increased in different areas, such as the haematology, prostate and the psychosocial portfolio. Within the prostate tumour group, the UK Genetics Prostate Cancer Study (UKGPCS) recruited a large number of patients. POETIC and PERSEPHONE continued to recruit, but the closure of TARGIT-A and REACT has reduced the number of patient participants to breast trials. The activity within the colorectal tumour group increased with twelve patients in -. Within the lung tumour group, MALCS continued to recruit patients; however, accrual to the ET Trial fell after a major eligibility amendment excluded all patients with squamous histology. The cross-cutting psychosocial study CanTalk opened to recruitment and the first patient was randomised. In addition, the PulMiCC trial opened after significant delays. Finally, the BRIGHTLIGHT Teenage & Young Adult study opened to recruitment just prior to year-end. A notable challenge during - was the vacancy of the CLRN Research Nurse post for a full calendar quarter. The lack of regular data support remained an ongoing challenge, as in prior years. Collaborative work between WH and RFH continued due to consultants oncologists and surgeons working across both sites. The NLCRN provided Lead Nurse and QA support and also a CTP based at WH.

43 Portfolio and Overview - Table G: Patient Referral from WH to other NLCRN Trusts - Referring Hospital Whittington Hospital NHS Trust Patient referred to University College London NHS Foundation Trust TOTAL Patient Total 6 Examples of most common trial referrals BRIGHTLIGHT, CONVERT 6 Focus for -4 One focus over the coming year is to expand the portfolio of active and increase recruitment. WH has expressed interest in opening commercial trials and NIHR industryadopted trials. Since the closure of ATTRACT- in Autumn, there has been no commercial trials activity and so this area is ripe for expansion. to the UK-GPC Study is expected to rise significantly due to a recent substantial amendment which enables patients to be approached and consented in clinic, rather than being referred. WH also hopes to open a few new over the next coming year.

44 Portfolio and Overview - Follow Up Follow up data is not routinely monitored by the network office as it does not directly relate to the opening of new. In instances when a backlog has occurred the research network was able to allocate some central data management resources. The research teams at the respective sites are able to provide an overview which is summarised in the Appendix. The NLCRN uses the NCRN Patient Status Definitions for follow up type : study data is collected by any member of staff designated in the site file study responsibility log. Study data collection does not include clinical investigations as described in type follow-up. UCLH have the highest level of follow-up activity (87 patients) compared to the other sites which is predominantly due to the size of its portfolio, GOSH comes in second with 64 patients in follow-up, mainly due to leukaemia and high survival rates in this group of patients. Barnet and Chase Farm and Princess Alexandra sites had the lowest number of patients in follow-up, again due to the portfolio size, and consecutively (see Appendix ). Non-Portfolio Activity The NLCRN has additional activity in commercial and local academic across the network s Trusts. This information is captured using the trial management database EDGE, which recently migrated to a new version resulting in a slight lag in recording data for new local academic. The recruitment of active commercial has remained stable in -, recruiting patients. Due to the drive to ensure that locally developed are adopted on to the NIHR portfolio, the activity in this part of the portfolio has not significantly increased. Tumour groups with improved commercial activity include haematology, gynaecology and genetic, with recruitment across multiple sites. The Quality Assurance Manager and the Governance Manager send out frequent reminders to the site staff to update patient data on EDGE version, ensuring that the full activity of research teams is captured.

45 Workforce Section : Workforce Infrastructure The Centralised Team The NLCRN supports a mixed model of staff appointments with a core centralised team and a wider devolved team at the different hospitals. The new RNM/Lead Nurse started in September to work alongside the part-time RNM and by being full-time, has been able to provide additional crucial day-to-day operational management. Currently this post leads on workforce development for the network and is part of the Pan-London Training. One of the strengths of the centralised team is excellent team working and the ability to absorb and cover vacancies whilst still being able to provide an excellent operational service. This has been of particular benefit during this period when we have had a considerable number of vacancies due to staff turn-over. Of note, the Senior Clinical Trials Administrator left her post during the year and so it became crucial to cover this post to minimise the effect on the wider network, the set-up of and ultimately the delivery of clinical trials. One of the newly appointed Data Managers has been successfully covering this role. The centralised team and its far reaching remit are crucial to the success of the wider network, both operationally and strategically. Our centralised trial set-up facilitates and encourages interaction with the wider network and provides day-today contact with Trusts and R&D Departments. With the centrally managed Data Managers and Clinical Trial Practitioners spending half a day a week in our central office, they have office projects such as supporting study set-up and audits, which gives a better understanding of the clinical trials processes and also serves as professional development. The Senior RNM post provides oversight and strategic leadership for the Network as well as supporting the local ECMC functions and providing management for the Cancer Clinical Trials Unit at UCLH. The QA Manager has responsibility to maintain SOP s and undertake audits across all sites whilst the Industry Manager supports the NIHR commercial trials across the network. The job-share RNM works with all sites which results in good communication and allows us to effectively performance manage sites.

46 Workforce Figure 6: Centralised NLCRN Team Organogram Dr John Bridgewater NLCRN Clinical Lead (.WTE) Dr James Lyddiard Senior Research Network Manager (.WTE) Christine Menzies Aderonke Adebiyi Masuma Harrison Network Industry Manager (.4WTE) RCF funded NLCRN & UCL ECMC Manager (.WTE) NLCRN funded NLCRN Manager (.WTE) NLCRN funded Vacant Senior Administrator & Research Governance Manager (.WTE) ECMC funded Guy Schroeter QA Manager (.WTE) NLCRN funded X Clinical Data Managers Emma Douch Clinical Trials Assistant (.WTE) NLCRN funded Gayle D Souza (.WTE), Gita Parmar (.WTE), Vacant (.WTE) NLCRN funded - RCF x Clinical Trials Practitioners Azmina Verjee (WH) (.8WTE) NLCRN funded; Vacant (BCF) (.wte); Vacant All research staff across trusts that are managed locally at site, irrespective of funding source work on both NIHR and non-nihr trials. They are managed within their Trusts by either a research manager or team leader or by a senior research nurse. Where they are the sole members of staff or work within a very small team they are managed by the Lead Nurse for cancer.

47 Workforce Table 6: Whole Time Equivalents across the Whole Research Network Trust Total Nature of posts research of posts resource UCLH Oncology 8.8WTE UCLH Haematology.8WTE UCLH Other 4.8WTE UCLH CRF 7. WTE RFH 4.6 WTE GOSH 7. WTE WH. WTE BCF.8 WTE. WTE Research Managers. WTE Team Leaders 4.8 WTE Research Nurses. WTE Clinical Trials Practitioners.4 WTE Radiographer.6 WTE Data Managers. WTE Administrator. WTE Research Managers.7 WTE Research Nurses. WTE Clinical Trials Practitioners. WTE Data Managers. WTE Administrator.7 WTE Head of Trials.9 WTE CR UK Lead Nurse. WTE BRIGHTLIGHT & BCRT POPP & other. WTE Lead Research Nurse. WTE Clinical Portfolio Manager 7.6 WTE Research Nurses. WTE Clinical Trials Coordinator. WTE Data Managers. WTE Lab Manager. WTE Lab Technician. WTE Administrator. WTE Lead Nurse. WTE Clinical Portfolio Manager.6 WTE Research Nurses 6. WTE Clinical Trials Practitioners. WTE Data Managers. Admin & Technical. WTE Lead Nurse. WTE Research Associate. WTE Research Nurse. WTE Data Managers. WTE Administrator. WTE Research Nurse. WTE Data Manager/Administrator NLCRN component of total resource (inc RCF).9 WTE. WTE WTE 8.6 WTE.8 WTE Clinical Trials.WTE

48 Workforce NMH 6.9 WTE PAH Harlow.84 WTE PAH Epping Centralised staff. WTE Total. WTE Practitioner. WTE Data Manager 4. WTE Research Nurses. WTE Data Manager.7 WTE Administrator.4 WTE Research Nurse.8 WTE Clinical Trials Practitioner/Administrator. WTE Data Manager. WTE Research Nurses. WTE Senior Research Manager. WTE Research Manager. WTE Lead Nurse.4 WTE Industry Manager. WTE QA Manager.9 WTE Clinical Trials Practitioners. WTE Data Managers. WTE Senior Admin & RGM. WTE Administrator 8.WTE.84 WTE 4.WTE 8.98WTE 8.84 WTE Workforce development We remain a part of the South East Region Workforce Development. Aderonke Adebiyi has acted as the nominated representative of the South East Region Training and Education (T&E) for the NLCRN and is responsible for the dissemination of education events held across NLCRN. GCP training is held -4 times a year by an external facilitator. Aderonke Adebiyi has undertaken the NIHR GCP Facilitator training and aims to support GCP training within the network in the future. The NLCRN hold quarterly research forums to which all research staff working on cancer clinical trials throughout the network are invited. The forums include presentations from staff at individual trusts on their varied portfolio s and speakers of wider general interest. The forum is also used as a way to update all staff on local/national measures and also offers opportunities to network and forge relationships. In addition the RNM meets with sites at bi-monthly meetings (particularly the smaller trusts) to encourage staff look at recruitment figures and trouble shoot where necessary.

49 Workforce Additional Local Workforce Initiatives We held a centralised team away day in November It was positively received by all the staff and felt to be of great value to a team that do not necessarily work together on a day to-day basis, developing team building and problem solving. We have also continued with our team staff meetings, Research Forums and Induction sessions throughout the year which have proved to be a great success. Further to the creation of a network quality assurance forum by our QA manager, we were able to hold a half day SOP training session in November hosted by the NLCRN to increase knowledge and importance of SOP s, discuss QA issues in greater depth and learn more about QA principles and methods. There are also plans to audit the SOP s across the network focusing on specific trials. Half-day Good Clinical Practice (GCP) refresher courses are run in-house with an external trainer three or four times a year. The primary reason these are held internally is to provide ease of location and a convenient time for both our clinicians and network staff. Other local GCP courses are available to staff predominantly provided by the Joint R&D Office. The E-Learning Module was successfully introduced at UCLH in to increase the awareness of clinicians about SOPs and complete competency assessments on specific SOPs. There has been a positive response and compliance has greatly improved with 6% of PIs completing the module. From April, the team will only approve new trials through the TFC if the PI has completed the SOP training. Conferences were well attended this year. The network was able to fund (or part fund) places for network staff at ASCO and the NCRI Conference with feedback being given to the wider network at the research forums.

50 Patient and Public Involvement (PPI) Section 4: Patient and Public Involvement (PPI) Patient and public involvement (PPI) is integral to the function of the NLCRN. We have PPI representatives who attend the NLCRN Steering Committee and provide in-sight from a non-professional perspective. Andrew Poulter who has been one of our Steering Committee s Representatives since initiation decided to stepdown in /. We would like to thank Andrew for his important contribution over the years. The NCLRN additionally held a cancer research public open day on Saturday 8th April, the aim of which was to help raise awareness of cancer clinical trials and the exciting new research initiatives associated with the outcome of these trials, showcasing both early and late phase research at UCL/UCLH. As well as being a day aimed at patients and the public in the local area, patients were heavily involved in the planning of the day. A planning group was created between the NLCRN, UCL ECMC and a few consumers, who were also recruited to this group, two from the research network and three from the ECMC. The consumer representatives provided invaluable advice on the structure and content of the day. The day started by exploring the world of cancer research at UCL, learning about how advances in understanding cancer genetics are improving the outcomes for patients with cancer, the role of gene therapy in fighting cancer, and how advances in imaging are helping to improve cancer treatments. Lastly, talks were given from patients perspective by hearing about a patient s experience in participating in a trial. The attendees were able to participate in demonstrations at the venue of their choice (The UCLH Macmillan Cancer Centre, the UCL Cancer Institute and the UCLH Clinical Research Facility). The demonstrations included the opportunity to visit the first PET MRI scanner in the UK and hear a discussion on its involvement in novel research projects, extraction of DNA from strawberries and taking part in practical demonstrations of sample collection and centrifugation in the CRF. With a great number of attendees, the feedback received was extremely positive both on the day and via evaluation forms.

51 Patient and Public Involvement (PPI) Feedback from the PPI open day was gained from a comprehensive questionnaire completed at the end of the day. Attendees were asked to rate each guest speaker along with the afternoon demonstrations for interest as well as giving general feedback on aspects such as the catering, venue and length of day. The overwhelming majority of feedback was positive, with 98% of those who attended saying they would recommend the open day to others and 9% agreeing that the day met their expectations. The afternoon demonstrations proved very popular, especially within the new UCLH Macmillan Cancer Centre where over 9% strongly agreed that they found the session interesting.

52 Patient and Public Involvement (PPI) Social Media and PPI: The NLCRN Twitter Feed Social media refers to the means of interactions among people in which they create, share, and exchange information and ideas in virtual communities and networks. A NLCRN twitter account was set up on nd of March to facilitate communication with regards to the PPI Strategy, as well as a platform to raise awareness of network events and projects. This has been a huge success and our followers are rising every day. We received a lot of publicity by being re-tweeted and being mentioned in other feeds. The QA Manager is working to use this platform to increase public awareness of cancer clinical trials in the North London area as well as enhance the social media profile of the NLCRN, reaching parts of our network that we previously had not. Considering that, some of the tweets are related to new finding in oncology but in a non-technical vocabulary. You can follow us at

53 Other Initiatives Section : Other Initiatives One of the main initiatives within our network this year has been working more closely with NEL and the CEL CLRN in preparation for the LCRN pilot which is due to start in April. This has involved a series of meetings including the clinical leads and management teams from North and North East London and the CEL CLRN. The pilot is aimed at informing the transition process due to start in April 4 in addition to building on the relationship with UCL Partners and London Cancer. Following on from this we have been working collaboratively with NEL to provide localised trial maps and detailed activity reports to all disease specific pathway boards on clinical trials recruitment across London Cancer, this will be useful in ensuring portfolio balance and delivery. The UCLP Harmonisation Project pilot for commercial research, managed by the CELCLRN is something that we also have been heavily involved in the delivery of. Two out of the three Hubs for this pilot are situated in the NLCRN network. The pilot was rolled out across UCLP in October and was aimed at providing a streamlined approach to obtaining NHS permission for commercial trials. Internal auditing of specific trials across the trusts within the network was carried out during -. This was aimed at ensuring that quality and standard measures were met. The feedback from the various sites across the network regarding this exercise was very positive and plans are being put in place to extend this further. In January The NLCRN migrated from EDGE version. over to EDGE version and one of our priorities here has been to ensure all staff across the network are trained in the use of EDGE version, evaluate their use of the database and encourage more comprehensive data collection. We plan to work with North East London in order to cohesively use information on EDGE for use within the LCRN Pilot and across London Cancer. Continual monitoring of NIHR and EDGE database accrual discrepancies takes place every months. The IM put together a newsletter for lymphoma commercial trials as this was an area where a greater number of open commercial trials were under performing compared to other areas. The newsletter listed sites that were performing well within NLCRN, all the open commercial lymphoma trials within the NLCRN, including the main inclusion and exclusion criteria and the contact details of the PIs and research nurses. A NLCRN twitter account was set up on the nd of March to facilitate communication with regards to the PPI Strategy, as well as a platform to raise awareness of network events and projects. This alongside the successful PPI open day has underlined the Network s PPI Strategy.

54 Future Plans Future Plans Looking forward to -4, the network plans to circulate a regular newsletter listing trials that are open within both NEL and NL CRN together with a Quality Assurance section. The hope is that this newsletter will lead to an increase in awareness of specific and therefore referrals across the network to help ensure all the trials meet their target within the recruitment window and highlight the importance of quality issues, e.g. SOP S, audits etc. The network hopes to improve on its recruitment as discussed in the trust by trust Focus for -4 sections (Section : Portfolio and ). to RCT S was down this year so we hope to work in collaboration with NEL to improve recruitment particularly in the rarer tumour groups over the coming year. Attendance at each of the UCLP Cancer Pathway Boards by a member from either the North or North East London. The Cancer Research Network management team will ensure that research is given a high priority on each of the pathway boards. We will be working with North East London and the CEL CLRN in the LCRN pilot in /4. One of the areas we will be focusing on within the pilot is a centralised model for opening all new and processing protocol amendments across both networks. In preparation for the transition we will be working with and supporting the CEL Transition Management Team to help identify any issues /achievements that can be taken forward to inform the transition in 4. We will be running Induction days for new staff within the network every months. This comprises of an overview of the Network by the Network Manager followed by Training on EDGE and SOP Training conducted by the Network s QA Manager. The QA Manager plans to start running more structured EDGE Training in a computer room to help sites to understand and practice in real-time. This will encourage the collection of accurate data by sites and therefore enable the Network to run monthly reports which can then be used in performance management of the portfolio. We would like to expand on the current research forums by taking it a step further and holding a day consisting of talks and opportunities for networking for all the Research Nurses, Clinical Trials Practitioners, Data Managers and administration staff across North and North East London. Research forums in Quality Assurance might also be developed. We aim to carry out Internal GCP audits across Trusts within the network in 4. This will consist of a comprehensive audit programme covering Investigator and Pharmacy Site Files, source data and Case Report Forms, SOPs and EDGE

55 Future Plans completion. We hope to start these audits in July to improve and maintain quality standards in our research. Twitter activity will also be updated weekly with the latest cancer research news. Follow us on

56 Appendices Appendices Appendix : NLCRN Portfolio Activity Table 7: Portfolio and for - (compared against forecast recruitment) Key Recruited at least 9% of forecast Recruited to 66-89% of forecast Recruited less than 6% of forecast Primary CSG Anaesthesia, Intensive Care and Cardiology Bladder Cancer Study Acronym / Short Title MCRN (BUP) Active Status Closed - in follow-up BOXIT Bladder Cancer Study Design Closed - in follow-up POUT Bladder Cancer TOUCAN (Bladder cancer) Bladder Cancer BOLERO Closed - in follow-up 7 8 Bladder Cancer HYMN Brain Tumour NBT Brain Tumour DORIC - Phase II trial of cediranib +/gefitinib for recurrent glioblastoma Feasibility of -ALA and Carmustine wafers for Glioblastoma (GALA-) EORTC 69 (TAVAREC) Closed - in follow-up Phase I trial of IMA9 multipeptide vaccine plus GMCSF in glioblastoma BR4 (EORTC 6-4) Closed - in follow-up 6 4 Brain Tumour Brain Tumour Brain Tumour Brain Tumour Forecast Randomisation

57 Appendices Primary CSG Breast Cancer Active Status Breast Cancer Study Acronym / Short Title Abiraterone Acetate in Advanced or Metastatic Breast Cancer Chemo-NEAR Breast Cancer Endo-NEAR Breast Cancer FAST-Forward Randomisation Breast Cancer SOLD Breast Cancer SUPREMO Breast Cancer Forecast 8 Closed - in follow-up TNT Breast Cancer EPHOS-B Breast Cancer TARGIT Closed - in follow-up 8 Breast Cancer NeoExcel 6 Breast Cancer Closed - in follow-up Breast Cancer REACT- European Celecoxib Trial SEARCH 4 Breast Cancer PARP BRCA trial Breast Cancer ARTemis Closed - in follow-up 6 Breast Cancer Persephone Breast Cancer POETIC Breast Cancer BOCS (formerly FBCS) 4 7 Breast Cancer ICICLE 4 Breast Cancer IMPORT HIGH 6 Breast Cancer AFFECT 4 Breast Cancer COPE Non- Study Design

58 Appendices Forecast Primary CSG Study Acronym / Short Title Active Status Randomisation randomised Study Design Breast Cancer OPTIMA 4 Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia Children's Cancer and Leukaemia CNS 4 (Functional Imaging of Tumours) EPOC Doxorubicin in children Closed - in follow-up Both PK 6 7 (ActD in children) Closed - in follow-up PK 6 9 (Infant PK) Closed - in follow-up CNS 4 (LOW GRADE GLIOMA SIOP-LGG ) FACT study Closed - in follow-up 4 9 ET (EURO-E.W.I.N.G. 99) UKALL NB 6 (High Risk Neuroblastoma) LK 6 (Interfant 6) 9 LT 7 (SIOPEL 6) CNS 4 (Functional Imaging of Tumours) EuroNet PHL-LP Hodgkin's 87 Both GD: Long term continuous infusion ch4.8/cho plus s.c. aldesleukin (IL) Improving Population Outcomes for Renal Tumours of Childhood (IMPORT) 8 Children's Cancer and Leukaemia

59 Appendices Primary CSG Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Colorectal Cancer Genetics Gynaecological Cancer Gynaecological Cancer Gynaecological Cancer Study Acronym / Short Title Follow up to MOSAIC study Study Design Aristotle New EPOC Closed - in follow-up 4 NSCCG 4 EPOC B 6 FOXFIRE Pulmonary Metastasectomy in Colorectal Cancer (PulMICC) ROLARR (RObotic versus LAparoscopic Resection for Rectal cancer) SCOT Both Tumour Angiogenesis CORGI 9 EMBRACE 6 A Phase II Clinical Trial in Patients with BRCA defective Tumours (6MP) CIRCCa Closed - in follow-up DESKTOP III Forecast Randomisation Predisposition to serrated neoplasia and tumours (PRESENT) study FOxTROT Active Status Closed - follow-up complete 4 4

60 Appendices Primary CSG Gynaecological Cancer Gynaecological Cancer Gynaecological Cancer Gynaecological Cancer Gynaecological Cancer Gynaecological Cancer Gynaecological Cancer Gynaecological Cancer Gynaecological Cancer Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Study Acronym / Short Title PARAGON Active Status SaPPrOC Study Design Closed - in follow-up INTERLACE PORTEC meoc PETROC/OV ICON8: Weekly Chemotherapy in Ovarian Cancer GROINSS-V II 4 8 ICBP MODULE 4: Root causes of diagnosis and treatment delay in cancer CLL (CamDexRev) Suspended Both 4 COSMIC Version. EsPhALL InCiTE - Intracranial haemorrhage in thrombocytopenic haematology patients LenaRIC 6 MYELOMA XI 6 RIAltO RIC UCBT Forecast Randomisation

61 Appendices Primary CSG Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Study Acronym / Short Title REVEAL Active Status Randomisation Study Design Forecast AML 6 Closed - in follow-up 6 PT Closed - in follow-up Both 4 SPIRIT Closed - in follow-up TEAMM: Tackling early morbidity and mortality in myeloma MAC UCBT MUK one Closed - in follow-up MUK three 6 WT TCR- LI- 4 6 AML 7 4 Bortezomib Consolidation Trial EBV associated NK/T cell malignancies MARALL Myeloma X Relapse (Intensive) Closed - in follow-up UKALL 4 AML 8 Pilot Both 6 4 PADIMAC 7

62 Appendices Randomisation Study Design 4 Forecast Both ART DECO De-ESCALaTE HPV Both Head and Neck Cancer: molecular, cellular and immunological mechanisms SEND TITAN COSTAR Closed - in follow-up HeadandNeck The LEONIDAS study 7 PET-NECK study Closed - in follow-up Lung Cancer A phase III randomised study to investigate the use of adoptive cellular therapy (ACT) CONVERT Lung Cancer STOMP Both Lung Cancer TIMELY In Set-Up Pending NHS Permission Primary CSG Haematological Oncology Haematological Oncology Haematological Oncology Haematological Oncology Head and Neck Cancer Head and Neck Cancer Head and Neck Cancer Head and Neck Cancer Head and Neck Cancer Head and Neck Cancer Head and Neck Cancer Head and Neck Cancer Head and Neck Cancer Immunology and Inflammation Study Acronym / Short Title ALLR Active Status CMV-ACE/ASPECT LenD (Lenalidomide in CLL) MUK five

63 Appendices Study Acronym / Short Title REST - Chest Irradiation in Extensive Disease Small Cell Lung Cancer ET Trial Active Status Closed - in follow-up Randomisation Study Design Forecast Lymphoma AITL Closed - in follow-up Lymphoma Intestinal t-cell trial (ITCL) Lymphoma MiniAllo Lymphoma ReACH Lymphoma IELSG Closed - follow-up complete Lung Cancer MALCS (Mesothelioma and Lung Cancer Study) Streamline L 6 Lymphoma 8 6 Closed - in follow-up Lymphoma PACIFICO Lymphoma NSHLG - National Study of Hodgkin's Lymphoma Genetics EuroNet PHL-C Hodgkin's 4 Lymphoma R-CODOX-M/IVAC Closed - in follow-up Lymphoma 8 Lymphoma MELT MRI Evaluation of Lymphoma Treatment PAIRed 6 Lymphoma REMoDLB 6 Lymphoma 4 Lymphoma ProT4 (Prophylactic Transfer of CD4 Lymphocytes) RATHL Closed - in follow-up Lymphoma PET after cycles in NHL (sub-study) Closed - in follow-up Primary CSG Lung Cancer Lung Cancer Lung Cancer

64 Appendices Primary CSG Melanoma Study Acronym / Short Title NICAM Active Status Metabolic and Endocrine (not diabetes) Non-Malignant Haematology Palliative & Supportive Care Pharmacy and Pharmacology Prostate Cancer AIP Study of haematology in newborns with Down syndrome Depression and anxiety in prostate cancer MAGIC Closed - follow-up complete Closed - in follow-up Study Design Both 7 4 Prostate Cancer COMPARe study: COMparing treatment options for ProstAte cancer RADICALS (MRC PR) Prostate Cancer UK Genetic Prostate Cancer Study Prostate Cancer IMPACT Prostate Cancer INDEX Prostate Cancer STAMPEDE Prostate Cancer PROMIS Prostate MRI Imaging Study (MRC PR) Biliary Tract Cancer QoL Validation CanTalk V Anti-CD66 Radiotherapy RAPPER Renal European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy Surtime - EORTC 7 Psychosocial Oncology Psychosocial Oncology Radiotherapy Renal Cancer Forecast Randomisation 7

65 Appendices Primary CSG Renal Cancer Study Acronym / Short Title SORCE Active Status Closed - in follow-up Randomisation Study Design Forecast Renal Cancer TRANSORCE (sub-study of SORCE) Renal Cancer CARMENA Closed - follow-up complete Respiratory Sarcoma Magnetic Resonance Imaging of Lung Nodules CASPS Sarcoma OTIS Closed - in follow-up Sarcoma STRASS (EORTC 69-9) Sarcoma VORTEX BIOBANK Sarcoma VORTEX 7 Sarcoma STS 6 4 RMS (ESSG) 6 Sarcoma GeDDiS 4 Sarcoma Axi-STS Sarcoma STS 6 (NRSTS) 6 Testis Cancer Trial (formerly BEP ) Testis Cancer TRISST 6 The Teenage and Young Adults Clinical Studies Development Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer BRIGHTLIGHT: The TYA Cancer Cohort Study Barrett's Oesophagus Closed - in follow-up ESPAC -Tplus Closed - follow-up complete Closed - in follow-up ABC-

66 Appendices Primary CSG Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Upper Gastro-Intestinal Cancer Study Acronym / Short Title ViP Active Status Randomisation Study Design Forecast ST LEO (Lapatinib in Early Oesophagogastric Cancer) Immune responses in Hepatocellular Cancer v. TACE- Both BILCAP 6 ESPAC PET-PANC Closed - in follow-up BOOST 7 4 CUP ONE 9 ABC-4 Closed - in follow-up 6 Evaluation of a NonEndoscopic Device for Barrett's Oesophagus - BEST OCCAMS - Evaluation of revised staging system for GOJ adenocarcinoma TRANSBIL (Biliary MCM Study) 6 9 9

67 Appendices Appendix : Delivery of NIHR Clinical Research Network adopted Commercial Studies Table 8A: Commercial which closed to recruitment nationally during the - reporting year Key Recruited at least 9% of forecast Recruited to 66-89% of forecast Recruited less than 6% of forecast Slashed green if recruitment is % behind time Missing information &/or there is not enough information yet to calculate the % time Study has not reported any recruitment data Clinical Studies Breast Haematology Lymphoma Colorectal Upper GI Children's Cancer & Leukaemia Lung Agreed target (RAG report) ( by date) 4 by // Actual of patients recruited to date 4 by 7// by // 4 by 8/9/ 4 4 by // NCRN4 SPARK NCRN88 by 9// by /6/ 6 NCRN4 BAGPAC NCRN6 by // 4 by /6/ NCRN44 PETEY NCRN48 ARCHER N.Midd by // by 8// 9 NCRN Ref No. NCRN CEREBEL NCRN BOLERO NCRN6 RESILIENCE NCRN KW4784 NCRN98 Comments This study was initiated without Network involvement, feasibility of site was not realistic The study was delayed in set-up due to the CRO and closed 6 months after it was open to recruitment which restricted the opportunity to recruit to target Delays in opening and the study closed early due to results of interim analysis

68 Appendices Clinical Studies Agreed target (RAG report) ( by date) by 8// Actual of patients recruited to date NCRN7 Diacchi by /7/ NCRN8 GOLD NCRN9 TRINOVA by /8/ by 8// NCRN Ref No. NCRN48 ARCHER UCH Renal Gynaecological Comments This study had delays both in the R&D approval process due to complex costing negotiations with the CRO (Ca months) approval process and post approval in opening to recruitment (Ca. months). Additionally feasibility was over-optimistic for this patient group. A trial summary was created and circulated across UCLP to encourage referrals Issues with IRMER approval from the CRO delayed set-up and issues with IMP storage highlighted at the Initiation Visit further delayed the opening of the study at site. As the study also closed early this additionally impacted on performance

69 Appendices Table 8B: Commercial open to recruitment nationally during the - reporting year Clinical Studies Lymphoma Haematology NCRN Ref No. Agreed target (RAG report) ( by date) by // Actual of patients recruited to date NCRN69 ORCHARD UCH NCRN78 SABRINA by // by // NCRN46 GALLIUM PAH NCRN46 GALLIUM R.Free NCRN6 6 by //4 6 by //4 by // NCRN94 RAY by /4/4 NCRN7 BLAST NCRN69 by // by // NCRN6 by /6/ 8 NCRN7 by 8/7/ NCRN69 ORCHARD R.Free Comments This site was added at the end of without input from NLCRN. GSK were looking for additional sites to help ensure the national target was met within the recruitment window. The IM has met with the PI/RN and also representatives from the Sponsor to discuss the issues. A flyer has been sent to all Trusts within NE & NL to try and boost referral numbers This site was added without input from the NLCRN. The Sponsor has since closed this site due to zero recruitment. Should not really have been included in the figures for NLCRN Patient acceptance of study is low ( approached and all did not wish to participate). A flyer has been sent to referring hospitals to encourage further screening. IM liaising with Guy's to identify approach to improve recruitment

70 Appendices Clinical Studies Upper GI Colorectal Breast NCRN Ref No. Actual of patients recruited to date NCRN7 Agreed target (RAG report) ( by date) by 8//4 NCRN4 by // NCRN4 ENDEAVOR R.Free NCRN4 ENDEAVOR UCH NCRN4 BIBF by //4 Comments No recruitment yet nationally R&D approval obtained, delay in set-up of eprescribing system. Formal screening soon to start and likely to meet target TBC Still being set up at UCH (not going through UCLP harmonisation) 6 by /7/ NCRN ADIPEG NCRN9 4 by //4 4 4 by // NCRN8 carcinoid tumours NCRN79 by /4/4 4 by /4/ NCRN8 by 9// Rare patient group unlikely to see eligible patient in current timeframe NCRN477 TBC NCRN86 ALTERNATIVE NCRN APHINITY NCRN4 PERUSE by 7//6 Black nationally Difficult to recruit to study, only patient entered in the UK by // 6 by /9/ by 8//4 NCRN47 BELLE 4 A month delay in opening after other UK sites due to delays in granting R&D permission for study and subsequent amendment challenging as IMP (Pertuzimab) was granted EU approval in March & since May has been listed on the National Cancer Drugs Fund list of treatment

71 Appendices Clinical Studies Gynaecological NCRN Ref No. NCRN49 BELLE NCRN46 TDM R.Free NCRN46 TDM PAH NCRN 4EVER UK NCRN9 TRINOVA NCRN7 Agreed target (RAG report) ( by date) 4 by 9//4 Actual of patients recruited to date by /9/4 by /9/4 4 by // 4 4 by /8/ TBC Study opened for recruitment on //, the st patient consented NCRN8 NCRN4 by 6//4 by 9// NCRN9 HERBY GOSH NCRN9 HERBY UCH NCRN9 NCRN by //4 by //4 by /7/ by //4 NCRN8 LUX Lung 8 NCRN87 NCRN4 by // by //4 by // Head and Neck NCRN9 4 by // Prostate NCRN TERRAIN NCRN464 4 by /8/ 4 by // NCRN4 MELABIS by // Children's Cancer and Leukaemia Lung Melanoma Comments to recruitment no patients screened yet. No recruitment yet nationally Rare patient group. Screened but they were not eligible Rare patient group Rare patient group. opening the study No eligible patients since Screened 7 patients so far, no BRAF +ve patient identified Delays in the set-up & the initiation, PI is screening nd patient patient in screening, expected to be entered by the end of June

72 Appendices Clinical Studies NCRN Ref No. NCRN4 COMBI V (BRAK+MEK) NCRN47 COMBI-AD Agreed target (RAG report) ( by date) by 9/6/ Actual of patients recruited to date Comments by 7//4 Patient screening on-going

73 Appendices Appendix : Follow-up Table 9: Patient Follow-up s Hospital Study University College London Hospital Royal Free Hospital North Middlesex Hospital Whittington Hospital Great Ormond Street Hospital Leukaemia Lymphoma Myeloma BMT Head and Neck Neurology Breast Lung Sarcoma GI Gynae GU Uro-surgery Breast GI Lung Renal Melanoma Urology Neuro-Oncology Surgical Leukaemia Myeloma BMT Lymphoma Breast Urology Head & Neck Breast Lung Colorectal Prostate Cross-cutting Haematology Leukaemia Lyphoma Sarcoma Urology of patients

74 Appendices Barnet Chase Farm Hospitals Princess Alexandra Hospital Upper GI Brain Head & Neck Colorectal Breast Haematology Urology Lung Colorectal Upper-GI Lung Haematology Urology Total

75 Appendices Appendix 4: Executive Summary of Workforce Development Annual Report for London & SE England Key achievements and challenges of the Region during - The Pan London & South East Workforce Development Regional continues to benefit from the commitment and enthusiasm of its members; many of whom have put a considerable amount time and effort into planning, developing and facilitating the courses. The core cancer course programme of externally facilitated cancer courses ran successfully this year. Achievements within the group include, participation in the successfully concluded NCRNled Induction Handbook project by Heather Philipps, Helen Graham, Theresa Meehan and Sean Chinnathumby. This is a very thorough and comprehensive resource for new recruits to the cancer research network. Also, of note is the NCRN/CLRN Training & Development Collaborative Course. This was & is being led by Julia Simister (NCRN) and Emma Saunders (London South CLRN). It is a joint initiative between Pan London & South East Workforce Development Regional and South East CLRN training cluster. Several members of the Regional are Module Champions namely; Helen Graham, Carrie Weller, Nicola Southwell with Gillian Ellis acting as the overall Programme Coach. The Regional continues to particularly value the various communications courses and this is reflected in the regular provision of these courses, facilitated by several members of the Regional, throughout the year, namely Linda Dawson- Athey, Sandra Burt, Helen Graham & Anne Haldeos. Finally, Susan Palmer s efforts to manage the recruitment and appointment of a new Regional Workforce Development Lead in July-September should be recognised. Credit also needs to go to Veronica Sinclair, the Pan London & South East Workforce Development Administrator, who succeeded in keeping the planned training programme on track throughout the three months that no Workforce Development Lead was in post. Key priorities and challenges for the region for -4 The key priorities for -4 are: To plan a programme of courses within the budget available and to manage the payment and reconciliation & reporting of expenditure. To implement and manage the core cancer, communication and other course programmes. To design, develop & pilot a Team Leader Training Course. To design, develop & pilot Informed Consent & Pharmacovigilance workshops. To manage the changes in workforce development that will come with the organisational re-structuring from April 4 to ensure a smooth transition and continuity in workforce development provision.

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