North East London Cancer Research Network. Annual Report

Transcription

1 North East London Cancer Research Network Annual Report Financial Year

2 The National Institute for Health Research Cancer Research Network (formerly National Cancer Research Network) was created in response to the need to improve the support within the NHS for cancer clinical research, and to ensure that research is better integrated with cancer care. The NCRN was established by the Department of Health in April 2001 to provide the NHS with an infrastructure to support prospective trials of cancer treatments and other well-designed studies, and to integrate and support research undertaken by cancer charities. Its aim is to improve the speed, quality and integration of research, ultimately resulting in improved patient care. The NCRN increased involvement and recruitment into studies through the creation of 32 Local Cancer Research Networks across England, closely aligned to the Cancer Service Networks. North East London Cancer Research Network forms One of these 32 Local research Networks covering the whole of England. The NCRN was established by the Department of Health in April 2001 to provide the NHS with an infrastructure to support prospective trials of cancer treatments and other well-designed studies, and to integrate and support research undertaken by cancer charities. Its aim is to improve the speed, quality and integration of research, ultimately resulting in improved patient care. The NIHR CRN has established a proven track record and world-class reputation for increasing participation in cancer clinical research. Prior to its creation fewer than four in every 100 newly diagnosed cancer patients were estimated to be entering clinical studies. By 2011, more than 20 out of every 100 newly diagnosed patients took part in cancer studies (23.1%). 2

3 Executive Summary The North East London Cancer Research Network (NELCRN) was established in 2003 and is one of the 32 National Institute for Health Local Research Cancer Networks which cover the whole of the NHS in England. NELCRN serves a population of 1.5 million and represents among the most ethnically diverse and socially deprived areas in England. The Network coordinates cancer clinical research and facilitates study set up, delivery and governance of interventional and non-interventional research studies within the Network using a team of dedicated multi-disciplinary cancer researchers, nurses, trial coordinators and data managers. We currently have a portfolio of 120 studies. More than 17.4% of cancer patients took part in cancer research studies during 2012/13 with 2422 participants enrolled compared with 2143 participants in 2011/12. This compares with enrolment at the time of the setup of the NELCRN when there were only 37 cancer studies with only 2.7% taking part. Our key objectives and priorities for the year have been to maintain a balanced portfolio across all tumour sites and modalities and in particular to increase recruitment into interventional studies with an emphasis on increasing the number of studies and sites supporting the Industry sponsored portfolio in line with the National Institute of Health Research (NIHR) and the National Cancer Research Network (NCRN) objectives. Whereas we remain disappointed by the accrual to target for studies in many disease types and are working with the Clinical Study Groups to achieve more reasonable targets and improve accrual to improve these areas, we have achieved many of these objectives with an increased portfolio of 120 studies. Our patient and carer group membership and active participation has increased and largely in response to the feedback we have received from our patient advocacy and consumers groups, we have also increased recruitment to screening and prevention studies. This was felt to be particularly important in an area with high social deprivation and low cancer survival figures, often related to late diagnosis. We strive to improve patient access to clinical trials and patient choice by running clinical trials in local hospitals wherever possible. We actively encourage and monitor cross Trust referrals so that patients still have access to the whole clinical trial portfolio wherever possible. The success of the Network has relied upon and been dependent upon our ability to plan, agree and deliver the portfolio in the most efficient and sustainable way across the Network. This has been achieved by close working relationships with Provider Organisations. This is necessary for us to achieve our goal of having broader multidisciplinary team awareness of the importance of clinical research as well as involvement in recruitment and treatment of patients within clinical trials. For us to be able to achieve our goals of increase recruitment and the breadth of the clinical trial portfolio is dependent upon collaborative network wide working. There have been major changes that have occurred in the Network within the last year. Three of our Trusts, Barts and the London, Whipp s Cross and Newham merged into the newly created Barts Health NHS Trust. Simultaneously, there have been major organisational changes in cancer care within North London and West Essex, with the establishment of London Cancer, a partnership of NHS, academic, charity and cancer specialists dedicated to providing expert, compassionate care within an Integrated Cancer System. Lastly, we have been a pilot site for the Local Comprehensive Research Networks and have merged with our neighbouring Network in North Central London. This has been a particularly fruitful and rewarding exercise, demonstrating that the transition towards the planned research framework should go ahead smoothly. There is no doubt that incorporating all of these changes in a short time frame have been very challenging for staff, but these offer exciting opportunities for the future and we remain optimistic that we shall surpass our objectives for the coming year. 3

4 Table of Contents Executive Summary... 3 Table 1 North East London Cancer Research Network Profile : Organisation and Development of the Network Interaction with the Cancer Services Network :2 Interactions with other Research infrastructure Work Plan :4 Financial Statement : Portfolio and Recruitment Total Annual Recruitment Table 4 Network Portfolio, recruitment of participants benchmarked to national performance Recruitment by CSG NELCRN Recruitment by CSG and Trust Barking, Havering and Redbridge Recruitment by CSG Barts Health Recruitment by CSG Homerton Foundation University NHS Trust :7 Portfolio and recruitment compared against forecast Industry Follow up : Workforce a) Infrastructure b) Workforce Development Patient and Public Involvement Other Initiatives Appendix 1 Portfolio and recruitment (compared against forecast recruitment)_ Appendix 2 - Table A: Studies which closed to recruitment nationally during reporting year Table B: Studies which closed to recruitment nationally during reporting year Appendix 3 - Follow Data by Tumour Group and Trust Appendix 4. Organogram for NELCRN 2012/

5 Table 1 North East London Cancer Research Network Profile Size Section # Indicator Network value Minimum 25th Percentile National median and range Median 75th Percentile 1 Network Population (NCRN) (millions) Cancer incidence (NCRN) Number of new cancer patients treated/year (CWT data ) Funding 4 NCRN funding (Core + Research and Capability Funding) ( ) 665, , , , , ,220, Maximum Funding Management Staffing Portfolio Portfolio Delivery 5 Financial returns submitted on time (Y/N) Y 6 Spend to approved NCRN Core budget 100% 7 Spend to approved Research and Capability Funding budget 100% 8 Total wte NCRN funded staff 10 9 Total wte CLRN funded staff Total wte staff funded from RCF in Total wte other staff supporting NIHR CRN cancer portfolio in Number of NIHR CRN non-commercial cancer portfolio studies open Number of NIHR commercial cancer portfolio studies open Proportion of total NIHR national cancer portfolio open and recruiting Number of NIHR studies open to recruitment with no recruitment Return rate for expressions of interest for NIHR CRN commercial studies Response rate for Company Identified Site Reviews for NIHR CRN commercial studies HLO 1 Total number of participants recruited (NIHR cancer portfolio studies) Proportion of cancer patients recruited (NIHR cancer portfolio studies) (as % of NCRN cancer incidence) Proportion of cancer patients recruited to intervention studies (as % of NCRN cancer incidence) Proportion of cancer patients recruited to RCTs (as % of NCRN cancer incidence) Number of other (non-patient) participants recruited to NIHR CRN cancer portfolio studies Total number of participants recruited to NIHR CRN commercial cancer studies Proportion of cancer patients recruited to NIHR CRN commercial cancer studies Total number of NIHR CRN commercial cancer sites in the local research network that participated in studies which 25 closed nationally in HLO 2A Proportion of NIHR CRN commercial cancer study sites within the LRN delivering to time & target in % 0% 38% 54% 63% 75% 27 Proportion of studies attaining forecast recruitment 41% 28 Number of studies recruiting in that did not have a forecast Proportion of Cancer Research Network Peer Review Measures met 66.70% 30 Number of NCRI Clinical Studies Group Members Quality 31 Number of Chief Investigators for NIHR CRN portfolio studies 24 Workforce Development 32 Attendance at regional Workforce Development Group meetings 67% Patient & Public Involvement All returns submitted on time 33 Number of CLG members (Full and Associate members) Proportion of survey respondents from across the network reporting having discussed research (Q27)

6 1: Organisation and Development of the Network The North East London Cancer Research Network (NELCRN) was established in 2003 and is one of 32 Cancer Research Networks in England, serving a population of 1.5 million and includes the newly formed Barts Health NHS Trust (BH), Barking Havering and Redbridge University NHS Trust (BHURT) and Homerton Foundation University NHS Trust (HFUT). The Networks key objectives and priorities throughout the year have been to maintain a balanced portfolio across all tumour sites and modalities; 7.5% recruitment into interventional studies with an emphasis on increasing the number of studies and sites supporting the Industry sponsored portfolio in line with the National Institute of Health Research (NIHR) and the National Cancer Research Network (NCRN) objectives has been a very challenging year for the Network. The merger of three trusts, Bart s and the London, Newham and Whipps Cross to form Barts Health on the 1 st October 2012; the replacement of the Cancer Service Network by the newly established Integrated Care System (ICS) London Cancer; the implementation of the Central and East London Harmonisation project in October 2012 and the introduction of the Central and East London Transitional Integrated Local Clinical Research Network Pilot. The implication of these major changes and the strategies adopted by the Network will be discussed in further detail in sections 1.1,1.2, 3.0 and 5.0 Despite the impact of these major changes with each presenting a different set of challenges and opportunities, this has been another very successful year for the North East London Cancer Research Network. The target of entering 7.5% of patients into interventional studies has been surpassed with a total of 8% being achieved in 2012/13, and the number of patients entered into industry supported studies has increased by a further 65% from the previous year. The increase in recruitment despite all the challenges presented has only been possible due to the perseverance and the enthusiasm of a stable and established work force. The Network continues to operate as a hybrid model. The inner trusts which include Barts Health and Homerton are predominantly managed by the Central Research Network team and the outer trust BHRUT continues to be managed locally by the Lead Research Nurse and the Local Cancer Management Team. Organogram appendix 4. The Network staff, continue to use a Tumour Site Specific Team approach in which each team comprising of a Team Leader, Research Nurses, Clinical Trials Practitioners and Clinical Research Assistants, work together on a specific portfolio of studies across all sites within the Network via the established referral pathways between the outer hospital sites and the two cancer centres. As well as promoting a strong multidisciplinary team approach and continuity of care for patients this strategy also provides equity of access to all patients across the Network to high quality NIHR cancer clinical trials and research studies. Table 1 below outlines the size and scale of the current workforce to which there have been no significant changes from the previous year. Table 2 Infrastructure Funding source Number of individuals in post Whole time equivalent/pa % of Total Workforce NCRN % CLRN % RCF % Other % 6

7 1.1 Interaction with the Cancer Services Network Towards the end of the previous financial year the Cancer Service Network had taken on more of a commissioning role and the provider functions including research were integrated within the University College London Partners (UCLP) Provider Network. UCLP encompasses all the trusts within North and North East London. The provider functions being managed through an Integrated Cancer System with the Tumour Advisory Boards being replaced by an Integrated Care Pathway Board led by a Clinical Pathway Director with the remit of improving outcomes and patient care along a designated cancer pathway which has resulted in the redesign of cancer services provision and care pathways across the patch. These groups have restricted membership which includes nominated Research leads with some setting up designated research groups with the remit of working with the networks to support and develop a portfolio of studies within their designated specialities. Both the Clinical Leads from North and North East London sit on the UCLP Research Implementation Board which is responsible for promoting research and ensuing that research has a high profile and visibility across UCLP as well as providing a direct communication channel between the pathways boards and UCLP Directorate Board. The implementation of the ICS has led to the development of collaborative working between North East and North London and includes joint pathway board reports and the development of joint tumour portfolio research study maps. The pathway board reports include all the NIHR metrics as well as local recruitment at a trust, tumour group and Network level. All predicted recruitment at an individual study level is recorded on a year and overall target as defined by the Site Specific Information Form (SSIF). All targets are captured by the rag rating system and are provided to the pathway boards on a monthly or ad Hock basis. The overwhelming demands of cancer research information from the pathway boards led to the development of a single spread sheet capturing all the required data which is now provided to the Lead Pathway Board Coordinator on a quarterly basis for dissemination to the appropriate Boards. As the Pathway Boards mature and with the implementation of integrated research groups across all the pathway boards, it is anticipated that these reports will be evaluated in order to identify areas for improvement and to share best practice across London Cancer. By means of membership and expertise these groups are best positioned to manage the portfolio, identify areas of weakness, areas of good practice and support the network in ensuring the balance and size of the portfolio. It has been agreed that the management teams from both networks would ensure that membership of each board and research group would be supported by a member of the management teams from either North or North East London Cancer Research Network. Not only does this model facilitate collaborative working it also allows for sharing of resources, the establishment of referral pathways across both Networks, facilitate the opening of studies with smaller recruitment targets or in rarer cancers across a limited number of sites as well as supporting the networks in achieving the High Level Objectives set out by the NIHR. The ICS London Cancer model has been further developed locally by the introduction of the Central and East London Transitional Integrated Local Clinical Research Network Pilot. The aim of which is to establish a local Clinical Research Network structure across Central and East London whilst retaining the formal structures (the Local Topic networks) which are already in place locally. This will involve further collaborative working with North London and will include: a centralised model for opening new studies across both networks; relocation of offices for the core management team to UCL; joint pathway reports to London Cancer pathway boards; the appointment of an Industry Manager to support and develop the industry portfolio across both networks; joint steering group meetings, which take into consideration the separate functions of each Network in order to achieve compliance with the Peer Review Measures. 7

8 1:2 Interactions with other Research infrastructure Barts Experimental Cancer Medicine Centre (ECMC), the NELCRN and the Cancer Prevention Clinical Trials Unit form the Experimental Cancer Medicine Centre (CEMC) at Barts. The CEMC is responsible for the management of all cancer research across Barts Health. Joint initiatives include the joint appointments of a Quality Assurance (QA) Manger, Study Monitor and three commercially funded Chemotherapy Research Nurses to support the haematology portfolio. The remit of the QA Manager and Monitor include the development and management of a single set of Standing Operating Procedures, first patient review, monitoring of all non-monitored studies, training and education, support with external Monitoring and the devolvement of common systems and process across the network. A joint management structure had evolved for the management of the haematology portfolio and resources across Barts Health. However, it was soon realised that by merging the nursing workloads to include a mixture of early and late phase studies contributed to high levels of stress and anxiety within the haematology nursing teams. Also as cancer clinical trials are becoming increasingly more complex and targeting smaller more defined disease groups and frequently involve the use of new agents which the trust chemotherapy units were unprepared to administer, this role was increasingly being undertaken by the research nurses. In October 2012 it was agreed that the two groups should be separated although joint working in relation to an awareness of both portfolios was still encouraged, with the NCRN Lead Nurse taking on the role of managing this very large portfolio with the support of two Senior Team leaders, one leading on the lymphoma portfolio and the other the haematology portfolio. 1.3 Work Plan The key objectives for the work plan were to: To Increase percentage of studies recruiting to time and target both commercial and noncommercial The appointment of an Industry Manager to support and manage the Industry portfolio To develop a robust staff development and training programme To ensure timely and accurate data returns To maintain 7.5% recruitment to interventional studies and 10% into non-randomised studies. To increase on the number of participants entered into screening and prevention studies. Increasing recruitment to time and target has been unachievable due to the closure of many of the studies on the haematology and lymphoma portfolios in year. Following the merger of the three trusts BLT, Newham and Whipps X a number of posts were frozen including the Industry Manager post. However, a robust training programme is now available to all staff across the network. A marked increase in the timeliness and accuracy of data returns across the patch has been achieved following on from the internal monitoring, first patient review and the appointment of the CRAs at BHR. Both the 7.5% recruitment into interventional studies and 10% into non randomised studies has been surpassed and there has been a marked increase in the number of participants entered into screening and prevention studies. 8

9 1:4 Financial Statement The core budget for the North East London Cancer Research Network for was with Research Capability Funding (RCF) of , the expenditure for the same period was The success of this Network in being able to appoint an appropriately trained and stable workforce would not have been possible on the core budget alone. Prior to the advent of RCF and Comprehensive Local Research Network (CLRN) funding streams the Networks core budget was the only source of infrastructure funding available at Barts and the London NHS Trust, other than three commercially funded Haematology Research Nurses who ran the non-portfolio studies across this site. The Network was viewed as being solely responsible for the infrastructure funding to cover portfolio studies and not as an additional resource as intended. We anticipate that the loss of these funding streams will have a detrimental effect on the ability of the Network to attain future national and local priorities as well as to ensure the safe management of patients recruited onto portfolio studies. Loss of the NCRN core and RCF and the independent governing structures that manages these funds could potentially return this site to its pre NCRN research status. 2: Portfolio and Recruitment With reference to the tables and charts below the NCRN targets are based on the number of patients recruited with a diagnosis or cancer or pre-malignancy. The percentage of patients recruited is calculated using the expected number of cancers for the network population. The incidence used is 4600 new diagnosis per 1 million population. North East London has an estimated population of 1.5 million and the expected incidence is 6,900per year. Other recruits refer to volunteers recruited into screening and prevention studies from the general population and do not count towards this target. As they form an important part of the portfolio they are recorded separately as other recruits. The NELCRN is made up of a population that is generally younger, economically deprived and more ethnically diverse than England as a whole, with 35% of the overall population being made up from ethnic minorities, although this figure rises to 61% for Newham PCT and falls to 5% for Havering. The mix of socio-economic deprivation and ethnic diversity leads to variable cultural attitudes to clinical research and poses pragmatic challenges particularly in relation to language barriers. The below average age demographic also has an effect on actual compared to cancer incidence as demonstrated in indicator 3 of the NELCRN Research Profile. (Table 1 pg. 5) Definitions: Patient recruits with cancer or a pre-malignancy. Contributes to 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 studies). 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 9

10 2.1 Total Annual Recruitment Table 3 Total Annual accrual Incidenc e Numbe r RCT % of cancer incidence Patients Numbe r non-rct Other recruits % of cancer incidence RCT non-rct Total participant s As seen in the NELCRN profile (pg.5) the Network has an expected cancer incidence of 6,900, whilst the Cancer Waiting Time data for 2011/12 indicates that only 5,705 new patients were treated within the network during this period. This data is consistent with a link between ethnicity and the generally younger population. However this does pose many challenges in attaining the NCRN 10% target from a pool of over 1,000 patients less than the NCRN expected incidence of 6,

11 Fig 1 Total Annual Accrual As can be seen from table 2 and Fig.1 an upward trend in recruitment is demonstrated from 2008/9 with the Network achieving its highest recruitment levels in 2012/13. Although 2012/13 has seen a small decrease in the number of patients entered into randomised studies this is counterbalanced by the increase in the number of patients entered into complex non-randomised interventional studies as demonstrated in the NELCRN Research Profile. The decrease in the number of patients entered into non randomised studies is due to the closure of a large recruiting lymphoma study which recruited over 700 patients. Recruitment to screening and prevention studies has remained a priority area with an increase in recruitment of over 50% from the previous year. The Network work target of achieving 7.5% to interventional studies has been surpassed with a total of 8.0% of patients being entered into interventional studies in a small increase from the previous year. (Research Profile pg5 indicator 20) A further 9.4% were entered into non-randomised studies, giving an overall total recruitment of 17.4% for this financial year The charts on the following pages provide a comprehensive breakdown of patient recruitment across the local portfolio by clinical study groups and trusts. The tables also enable the Network and the site specific teams to compare themselves against the National recruitment rates. (Table 4 pg 12) 11

12 Table 4 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 Intervention Number studies Above average recruitment, the chief investigator for Bladder Cancer Lamb is based within the NELCRN and accounts for Above Recruitment majority of the recruitment within this tumour group Number studies The highest recruitment is due to Co-adopted Intervention Recruitment below Metabolic and Endocrine study Brain Tumour Number studies Breast Cancer Colorectal Cancer Highest Observation Recruitment Number studies Intervention Recruitment Below Number studies Below Observation Recruitment Number studies Intervention Recruitment Below Number studies Below average recruitment in this area is due to long delays in opening new studies which reflected in the below average number of studies open in this tumour group Gynaecological Cancer Haematological Oncology Head and Neck Cancer Lung Cancer Observation Intervention Recruitment above Number studies Recruitment above Number studies below Observation Recruitment Number studies Intervention Recruitment above Number studies above Observation Recruitment Number studies Currently there remains only one Head & Neck study Intervention Recruitment average open across the network SEND which is managed by Number studies the Saving Faces team based within BLT below Observation Recruitment Number studies Intervention Recruitment above Number studies Interventional studies are priority area for the network and this is reflected in the above average recruitment within this tumour group Despite of all the staffing issues within this tumour group, recruitment to haematology remains above national average Observation Recruitment below 12

13 Local Research Network totals compared to NCRN median CSG Indicator Network total NCRN lowest NCRN RANGE (graphic) NCRN highest Number studies Intervention Recruitment above Lymphoma Number studies Despite suspension of recruitment to all Lymphoma studies at Barts, recruitment remains above the national average Melanoma Prostate Cancer Renal Cancer Observation Recruitment Number studies Intervention Recruitment average Number studies above Observation Recruitment Number studies Intervention Recruitment below Number studies below Observation Recruitment Number studies Intervention Recruitment above Number studies below The above average recruitment within this CSG is due to the high recruitment of a single commercially adopted study. A focus has been to open more studies within this tumour group The largest proportion of patients were recruited from BHR and the majority into STAMPEDE. Attempts to open this study within Barts Health as been delayed due to an amendment Interventional studies are a priority area for the network and this is reflected in the above average recruitment within this tumour group Sarcoma Observation Intervention Recruitment below Number studies Recruitment Number studies Referred to specialist MDT at UCL Testis Cancer Observation Intervention Recruitment Number studies Recruitment above Number studies The above national average recruitment within this CSG is due to the high recruitment of a single commercially adopted study Upper Gastro-Intestinal Cancer Observation Intervention Recruitment Number studies Recruitment below Number studies Observation Recruitment Barts Health is a speacialist MDT for hepato-biliary cancers and recruitment has increased by 42% from the previous year. The remainder of the portfolio remained limited in the year 13

14 Local Research Network totals compared to NCRN median CSG Indicator Network total NCRN lowest NCRN RANGE (graphic) NCRN highest Number studies The only study open within this CSG is a phase 1 study with a All Clinical Studies Groups Intervention Recruitment global sample size of 40 Number studies Observation Recruitment Number studies Biomarker and imaging studies are included in the relevant Biomarkers and Imaging Intervention Recruitment CSG's Number studies Observation Recruitment Number studies All childrens cancers are referred to UCL and GOSH Children's Cancer and Leukaemia Intervention Recruitment Number studies Observation Recruitment Number studies No studies currently open within this CSG Palliative & Supportive Care Intervention Recruitment Number studies Observation Recruitment Primary Care Number studies No studies currently open within this CSG Observation Recruitment Number studies No studies currently open within this CSG Psychosocial Oncology Intervention Recruitment Number studies Observation Recruitment Number studies The majority of studies that fall within this CSG are captured Radiotherapy Intervention Recruitment within other tumour groups Number studies Observation Recruitment Teenage and Young Adults Number studies Brightlights has recently opened to recruitment Observation Recruitment Grand total Intervention Observation Number studies Recruitment Number studies Recruitment Key 25-75th Percentile Indivudual Network Total NCRN Median 14

15 2.2 Recruitment by CSG NELCRN Fig 2 For the purpose of visual clarity Figs 2A and 2B below have been broken down into two separate pie charts CSG s recruiting above 50 patients and CSG s recruiting less than 50 patients. Fig 2A Fig 2A shows the breakdown of recruitment into CSG s recruiting less than 50 patients. It should be noted that the network is above the national average recruitment in six of these CSG s, bladder, gynae, Melanoma, radiotherapy, renal and testes, four of which have Chief Investigators based within Barts Health. 15

16 Fig 2B Fig 2B shows the breakdown of recruitment into CSG s recruiting above 50 patients. Haematology, Lymphoma, Brain and Lung are recruiting above the national average. Lung, Lymphoma and Haematology have a number of Chief Investigators based within Barts health. It can also be seen in Fig 2 that the NELCRN has a broad but balanced portfolio across all tumour sites with the exception of sarcoma and children s cancers. The rarer and more complex studies are managed within the two cancer centres which provide both chemotherapy and radiotherapy services. There is very limited access to chemotherapy services at Newham, Whipps Cross and none at Homerton. Patients from these sites are referred into St Bartholomew s hospital for these treatment modalities via the previously established referral pathways. The majority of the studies on the NELCRN portfolio are composed of NIHR multicentre studies led by other national trials centres, however, the number of locally developed, adopted NIHR portfolio studies is steadily increasing. Interventional studies both randomised and non-randomised remain a priority area and make up 82% of the portfolio. The portfolio has continued to develop throughout the year with a total of 120 studies open to recruitment compared to 110 from the previous year. The Networks key objectives and priorities have been to maintain a balanced portfolio across all tumour sites and modalities; 7.5% recruitment into interventional studies with an emphasis on increasing the number of studies and sites supporting the Industry sponsored portfolio in line with the NIHR and NCRN objectives. Other priority areas have been to develop the upper GI, lung and skin portfolios in order to increase recruitment in these underperforming areas and to ensure a relevant portfolio of NHIR studies are open at all the trusts within the network in order to comply with HLO 6: Increase the percentage of NHS Trusts participating in NIHR CRN Portfolio studies... In compliance with the NHS Improving Outcomes Guidance North East London hosts a Specialist Pancreatic MDT based at Barts and the London, The MDT currently has eight open studies which include BILCAP, CRUK Mk-0752, CHR 2845, ESPAC 4, NCRN 301,Tace 2, VIP and PET PANC. A total of 33 patients have been recruited within this portfolio an increase of 42% from the previous year. In addition Barts and the London is a level four site for haematology. Patients are referred in from neighbouring Essex for consideration into most of the studies on the local haematology, lymphoma and melanoma portfolios. 16

17 Children s cancers and sarcomas are referred into the specialist MDT s located within the North London Cancer Research Network 2.3 Overall Recruitment by Trust It can be seen in the following tables and charts that all the Trusts within the Network are actively recruiting to the NIHR Cancer portfolio Recruitment by CSG and Trust Barking, Havering and Redbridge Fig 3A Fig 3B 17

18 BHURT is one of two Cancer Centres located within the network and accounts for 50% of the population within North East London. Although has been a challenging year for the research teams at BHRUT, the positive measures instigated has harnessed and resulted in very positive results at this site, demonstrated in the increased percentage of patients entered into breast and haematology studies. Engagement of the Research Dosimetrist in the latter part of the year has also seen a large increase in the number of patients recruited into radiotherapy studies. Please note this recruitment is not visible in fig 3B as this data is captured within the Breast CSG. The original staff capacity issues have now been resolved through the recruitment of three Clinical Research Assistants (CRA), who have supported study set up, amendments and follow ups. This has helped free up the Research Nurses time, to enable them to concentrate on recruitment, data processing and care of research participants. These highly skilled CRAs have proved a very valuable resource in supporting recruitment and the quality of research data timelines. The Research Nurse turnover at a critical time led to the trust engaging the services of agency research staff for an extended period, a situation which impacted on staff morale. Staff morale greatly improved following the appointment of the CRAs resulting in no further staff resignations since November 2012 and the discontinuation of agency support from January Areas of focus and plans for include: Increase the uptake of commercial trials at this green shoot site; Increase the portfolio within less active tumour groups, (lung and GI) whilst sustaining and fortifying the capacity and recruitment within the breast and Haematology portfolios and to increase the presence and capacity at King George Hospital. Table 5 Infrastructure Funding source Number of individuals in post Whole time equivalent/pa % of Total Workforce NCRN % CLRN % FSF 0 0 Other 1 1 8% 2.5 Recruitment by CSG Barts Health Fig 4A 18

19 Fig 4B Following the Merger of Barts and the London, Newham and Whipps Cross in October 2012 to form Barts Health, for the purpose of this report these trusts will reported as a single trust with all relevant data collated for the full year. As can be seen from Fig 4B haematology and Lymphoma make up approx. 50% of the overall portfolio and this reflects the commitment and enthusiasm of the teams within this trust. As previously discussed in section 1:2 a joint management structure had evolved for the management of the haematology and Lymphoma portfolios and resources across Barts Health. Following the depletion of the ECMC Nursing teams midyear and numerous local portfolio review meetings a decision was made to suspend recruitment to all but 5 studies within these portfolios, as well as putting a hold on the opening of all new studies. This strategy was implemented to facilitate the burden of follow up, ensuring patient safety, to deal with outstanding data collection and to prevent any further resignations of staff supporting this portfolio. To date all the outstanding issues have now been resolved and all the studies within these portfolios have re-opened to recruitment and the block on opening up new studies has been lifted, with priority being given to the commercial portfolio studies which were put on hold and subsequently affected attainment of the NIHR high level objectives at this site. Resolution of this situation has only been possible due the recruitment of additional CRA support and three dedicated research chemotherapy nurses funded from the available commercial income to support this large and very resource intensive portfolio. The change in Non RCT activity at Barts Health from the previous year as seen in Fig 4A is due to the closure of a large recruiting haematology study and the increase in other Non RCT is due to a large recruiting breast screening and prevention study. Table 6 Infrastructure Funding source Number of individuals in post Whole time equivalent/pa % of Total Workforce NCRN % CLRN % 19

20 RCF % Other Recruitment by CSG Homerton Foundation University NHS Trust. Fig 5A Fig 5B As seen in Fig 5A recruitment at this site doubled following the appointment of the FSF/joint trust funded Research Nurse in 2009/10 and a trust funded CRA in The loss of both posts at the beginning of the financial year has seen a gradual decline in recruitment at this site. Failure to appoint a Research Nurse 20

21 led to the trust appointing two CLRN funded CRA s with the remit of supporting the doctors with consent and data management. Breast remains the main recruiting CSG and includes a mix of both randomised and non-randomised studies. All the patients from this site entered into chemotherapy or radiotherapy studies are captured within the St Bartholomew s recruitment data. Future plans include the appointment of a Clinical Trials Practitioner to support recruitment at this site. As seen in Fig6 above the change in other non randomised activity from the previous year is due to the closure of icicle. Table 7 Infrastructure Funding source Number of individuals in post Whole time equivalent/pa % of Total Workforce NCRN % CLRN % FSF Other 2:7 Portfolio and recruitment compared against forecast Table 8 Total forecast patient recruitment for Total actual patient recruitment for Number of studies Reasons Total number of studies rated green (recruiting above forecast +/- 5%) Total number of studies rated amber (recruiting below forecast up to 20%) Total number of studies rated red (recruiting below forecast by more than 20%) 35 The majority of these studies are open across more than one site within the network. 3 Resource issues within Urology and Lung portfolios at BHR 48 Staffing issues resulting from the suspension of recruitment and the opening of new studies within the haematology and Lymphoma portfolios at Barts health Delay in opening new studies within Barts health as result of difficulties in obtaining ARSAC licences Very rare tumour groups or subtypes Resource issues within the Urology and Lung portfolios at BHR. 21

22 Accrual predictions were provided for a total of 86 studies either open or due to open in (Please see appendix 1 Out of these 86 studies 41% recruited to target or above forecast, 3% recruited below forecast up to 20% and 56% recruited below target by more than 20%. The reasons for the latter are listed in Appendix 1 and table 8 above. Performance to target continued to be monitored closely throughout the year, discussed monthly with the individual trusts, presented at each of the three steering group meetings, as well as being provided to London Cancer to be dissemination to each of the pathway boards on a three monthly basis. 2.8 Industry Appendix two includes recruitment against annual forecast for industry studies. These studies can be identified by the unique NCRN ID number. Appendix two contains details of recruitment to time and target. Table A includes studies which have closed to recruitment within the financial year and table B, studies which are open to recruitment in the same period. The industry report uses a RAG rating model: green, amber, red and black, the black denoting those studies which are open nationally but not open to recruitment at a local site level. As shown in the Research Profile indicators, 25 and 26 and appendix 2, thirteen studies closed during this period, with 54% recruiting to time and target. However, this percentage includes NCRN 262, an ECMC study which was suspended due to staffing issues, the NELCRN agreed to support this breast study which was approaching its closure date. Excluding this ECMC study the percentage of studies recruiting to time and target rises to 61.5% which falls above the national average target of 54%. Although the Network, falls above the national average recruitment level, more work needs to done in this important area in order to reach the NIHR 80% target. Plans in appointing an Industry Manager did not come to fruition until the beginning of the next financial year, however it is anticipated that with our recent successful appointment of a very experienced and committed individual this target will become achievable in the near future. In additional the post holder will be jointly funded by the NELCRN and North London Cancer Research Network, with the post holder working across both Networks and therefore promoting collaborative working across all the sites that fall within the boundaries of London Cancer. The Green Shoot initiative includes seven investigators from within the NELCRN. During 2012/13 BHURT were selected for three commercial studies, NCRN 178, NCRN 463 and NCRN 487. NCRN 178 recruited to time and target, NCRN 463 is recruiting above target and NCRN 487 is not anticipated to open until September BHRUT were unsuccessful in being selected as a site for NCRN261 due to the local Harmonisation Pilot project which mandated a single fixed overhead tariff for all the sites across North and North East London, which consequently made it more expensive for industry to open studies within the outer London trusts. This single tariff did not take into account the lower staffing overheads costs in the outer London sites. Subsequently, this issue has now been addressed and the overheads have been adjusted to avert industry from declining a site again as a result of overinflated prices. The Harmonisation project will be discussed in further detail in section 5 other initiatives A total of 17 studies remained open to recruitment in An update on current recruitment can be found in appendix 2 table B. 2.9 Follow up There are currently 1,934 patients on follow up across the NELCRN and a breakdown by trust is provided in appendix 3. For the purpose of this report, follow up has been defined as Study data that is collected from patients that have completed treatment but are still being followed up by any member of staff designated in the site file study responsibility log. (i.e. survival data yearly follow ups). It is anticipated that 22

23 once Edge is fully operational across the network all follow up data will be collected in line with the national definitions. Given the increasing levels of data management involved in long term follow up and continued recruitment, Clinical Research Assistants have been employed with the remit of managing long term annual survival and disease progression data, alleviating some of the administrative burden on the Research Nurses. In addition Band 5 Clinical Research Assistants have also been appointed, to support the nurses in clinic, recruit to epidemiology, surgical and screening and prevention studies as well as assist with the management of patients on follow up. This strategy has allowed the Research Nurses to focus their clinical expertise towards patients on active treatment and the intensive input needed when discussing trials with potential new patients and during the screening period. Clinical Research Assistants have now been appointed to support all the trusts within the Network, with three new posts being created at BHR alone and demonstrating a positive impact as discussed in section 2.4 (Page 17). 3: Workforce a) Infrastructure Funding source Number of individuals in post Whole time equivalent/pa % of Total Workforce NCRN % CLRN % FSF Other 1 1 2% The Network manages a total staffing of 39.6 W.T.E which include Research Nurses, Clinical Trials Practitioners, Clinical Trials Assistants and Data Managers, funded by Core, CLRN, commercial and RCF monies. The Nursing workforce has remained reasonably stable with the exception of the vacant Research Nurse Post at HFUT which we have been unable to recruit to. Future plans include the central appointment of a Clinical Trials Practitioner working 50% at this site and 50% within Barts Health. Retaining Recruiting Clinical Trials Assistant has been very challenging. The majority following training and gaining experience have been able to secure band 6 Practitioner posts within the other London Networks. In order to maintain a stable workforce the Clinical Trials Practitioner role has recently been introduced in NELCRN. b) Workforce Development NELCRN is part of the Pan London Work Force Development Group that provides programmes of training and education. (For further information on the Pan London Training Group and the group s annual report, please follow the attached link ( The Lead Nurse is an active member of this group and has been local lead and facilitator for the Communicating Randomised Control Trials study course. There have been two courses run at the Barts site in 2012/13 which were well attended and a further due in July 2013 and to date all staff have attended this course. (Pan London Annual Report 2012/2013) All staff currently employed by the NELCRN have access to participate in all courses provided by the Pan London Work force development programme and uptake has been excellent. On induction all new staff receives an individualised induction programme adapted to suit their requirements within the team. The work force is dived into teams led by a Band 7 Research Nurse Team leader who with the Lead Research Nurse is responsible for supervising the induction programme and identifying the learning needs of their staff. Within the first 6 months of employment all staff will have a learning plan and places booked on all relevant courses delivered by the Pan London Workforce 23

24 development Group for the coming year. Support visits are provided to all staff based within the outlying Network sites although they are not directly line managed by the Network. An induction plan and training is identified by the local Lead Nurse and these staff members are given the opportunity to attend all relevant NCRN courses. Regular GCP and Research Governance training courses are delivered within all the trusts and all NELCRN staff are expected to attend. Other Network Training & Development Initiatives.include the opportunity for staff to access and obtain places on cancer courses run at the Royal Marsden Hospital. This has been opportunity has arisen from the close interdisciplinary networking of the Lead Research Nurse and attendance at the relevant senior nurse meetings 4.0 Patient and Public Involvement All staff within the NELCRN are aware of studies available across the different trusts and hospital sites and close collaboration between the research teams and MDTs ensures patients are referred to the appropriate centres for access to the most suitable trials within the portfolio. In relation to patient involvement the NELCRN successfully obtained support from three patients to attend the Steering Group Committee meetings. In addition, the Network has access to the North East London Cancer Research Partnership Group and the ECMC Patient Group if additional consumer issues need to be addressed or further input required. Representatives of the NELCRN staff from across the network worked very closely with the Research and Development Teams from all trusts and hospitals within the network to ensure high profile coverage of International Clinical trials Day. Staff were involved in maintaining a presence at several high profile information points across the hospital sites to promote clinical trials and research with patients and public. This included an area where Charity organisations based within the Trust were invited to set up information stands (Saving Faces and Orchid). There was a refreshment area dedicated to a video loop on research within the Trust. All staff, working at St Bartholomew s Hospital are currently participating in a patient survey in collaboration with pharmacy to gather information on the experience of research patients on oral Chemotherapy /target therapies with same day prescribing. This is to explore how to streamline the service of same day phlebotomy, clinical review and prescribing Feedback from the National Cancer Patient experience Survey 2011/2012 put Barts Health at the forefront of patient satisfaction in the area of research involvement in certain areas. Results were disseminated to network staff at the team monthly meeting and areas where enhancement could be made were identified to enable staff to improve further on patient satisfaction and increase recruitment. In relation to working with colleagues and communicating research across multi-disciplinary teams the lead nurse attends the trust Senior Nurse meetings. This forum enables all new trials to be highlighted on a regular basis to the senior nurses and clinical nurse specialists to widen the awareness of trials available for patients 24

25 Other Initiatives The First Patient Review initiative has now been implemented across Barts Health. The QA monitor meets with all members of the research team following entry of the first patient to any new study (regardless of status i.e. commercial/non-commercial). For randomised studies, the review is performed after entry of the first patient to the experimental arm. This review is an opportunity to disentangle any logistical issues that may have arisen as the study has got underway such as IMP supply issues, unexpected issues with patient recruitment and staff resource issues. It is hoped that by reviewing study conduct at such an early stage, we can iron out any critical issues and ensure successful delivery and conduct of the study. In relation to the outer trusts a number of site file review have been undertaken and monitoring visits for studies where issues have been identified. Other joint ventures with the ECMC include monthly training and education seminars. Future initiatives will include the roll out of the first patient review to all sites and the development and implementation of a core set of SOP s. The implementation of the ICS has led to the development of collaborative working between North East and North London and includes joint pathway board reports and the development of joint tumour portfolio research study maps. The pathway board reports include all the NIHR metrics as well as local recruitment at a trust, tumour group and Network level. All predicted recruitment at an individual study level is recorded on a year and overall target as defined by the Site Specific Information Form (SSIF). All targets are captured by the rag rating system and are provided to the pathway boards on a monthly or ad Hock basis. The overwhelming demands of cancer research information from the pathway boards led to the development of a single spread sheet capturing all the required data which is now provided to the Lead Pathway Board Coordinator on a quarterly basis for dissemination to the appropriate Boards. The appointment of a Senior Clinical Trial Coordinator (CTC) responsible for the set up of all new studies across Barts Health has seen a marked improvement in this area. Previously this role had been undertaken by the site specific CRA s but due to increasing work pressures the set up and opening of new studies were not given a very high priority. The appointment of a Senior CTC towards the end of the financial year has resulted in the opening of a total of 19 new studies to recruitment within a four month period. A close working relationship with the Research and Development Department and the Harmonisation teams has led to a high proportion of these studies opening and recruiting the first patient within the 30 day target. The opening of a recent commercial study resulted in the team recruiting not only the first patient within the 30 day target but also the first patient in Europe. The implementation of Edge has now been rolled out across the Network with all sites now entering patient recruitment data. The uploading of the protocols onto the system has now commenced following the appointment of the Information Officer towards the end of the financial year. 25

26 The Introduction of The Harmonisation Project with its aim of streamlining the NHS permission processes across UCL Partners for all commercial studies from 29th October The Harmonisation Project works by having only one NHS permission for all sites within UCLP, this includes one costing, one contract, one Pharmacy and one medical exposure review allowing commercial organisations to open more sites at the same time with only one review thereby opening their research to a wider population. However, Harmonisation resulted in the Network obtaining 6 NHS permissions within a 7 months period. Out of these studies only three studies are currently open to recruitment. The remaining four studies are on hold pending local Radiology approvals. The introduction of harmonisation initially led to numerous communication issues with studies being granted NHS permissions without checking the feasibility of running the study at the site. Two weekly meetings have now been set up between the Harmonisation teams and Network staff in order to improve communication and resolves any issues encountered at a much earlier stage. The FSF funding was used to appoint a band 5 recruiting Clinical Research Assistant to support surgical and screening and prevention studies. The benefits of this role became evident in following a significant increase in recruitment to these priority areas within the breast portfolio. In over 620 research participants (other) were recruited into studies within this priority area, an increase of over 50% from the previous year. In addition good relationships have continued between the Network and the Screening and Prevention Unit based at Queen Mary University London. The Network continues to be approached for input at a very early stage of feasibility and protocol development. The most recent involvement have included input into a quality of life questionnaire to assess the risk and life style factors associated with the risk of developing breast cancer.. 26

27 Appendix 1 Portfolio and recruitment (compared against forecast recruitment)_ Study Acronym / Short Title Randomisation? Study Design Recruitment Forecast Recruitment Comments re 2012/13 forecast All Clinical Studies Groups A Phase I trial of GSK A in patients with advanced solid tumours Non-randomised Interventional 3 BOXIT Bladder Cancer Group Randomised Interventional 2 3 Resource issues LaMB Randomised Interventional PLUTO (PAZOPANIB VERSUS PACLITAXEL IN RELAPSED UROTHELIAL TUMOURS) Randomised Interventional 6 SUCCINCT Non-randomised Interventional 1 ARomatase Inhibition + SaracaTinib as Advanced breast CAncer Therapy (ARISTACAT) Breast Cancer Group Randomised Interventional 0 6 Delay in opening the study ARTemis Randomised Interventional 8 12 study closed early Barriers to early diagnosis with breast cancer Non-randomised Observational 10 7 Exploring the needs of breast cancer survivors after treatment Non-randomised Observational 21 7 FAST-Forward Randomised Interventional FH02 Non-randomised Observational Delay in opening study ICICLE Non-randomised Observational NCRN052 - CEREBEL Randomised Interventional 1 3 Closed early because of safety reasons NCRN122 BOLERO 3 - everolimus + trastuzumab + vinorelbine in HER2+, locally adv/ MBC Randomised Interventional patient enrolled but withdrawn from the trial due to disease progression NCRN250 APHINITY - Traz + Pertuzumab in HER2+ as adjuvant therapy in HER2+ Br Ca Randomised Interventional 6 5 NCRN354 PERUSE: Pertuz+Traz +Taxane in 1st line HER2+ advanced Br ca Non-randomised Interventional 1 NCRN402 BEACON: NKTR-102 vs TPC in met breast ca treated with taxane,anthracycline or capcetabine Randomised Interventional 1 NCRN463- TDM1 in Her2+ advanced / MBC Non-randomised Interventional 1 OPPORTUNE Randomised Interventional 0 3 Delay in opening of the study as there is no PI Persephone Randomised Interventional POETIC Randomised Interventional SEARCH Non-randomised Observational 4 SUPREMO Randomised Interventional 13 8 TNT Randomised Interventional 4 4 TOMMY trial:comparison of TOMosynthesis with digital MammographY Non-randomised Interventional Colorectal Cancer Group Aristotle Randomised Interventional 3 10 Limited number of patients meeting eligibilty criteria CReST Randomised Interventional 2 3 Limited number of patients meeting eligibilty criteria FOxTROT Randomised Interventional 1 3 Limited number of patients meeting eligibilty criteria Improving assessment and cancer treatment for older people in NEL Non-randomised Observational NCRN165 -FOLF(HA)iri in 2nd/3rd line irinotecan-naïve patients with metastatic colorectal ca Randomised Interventional 3 5 Eligibilty criteria New EPOC Randomised Interventional 4 4 NSCCG Non-randomised Observational Protocol amendment altered eligibility criteria Predisposition to serrated neoplasia and tumours (PRESENT) study Non-randomised Observational 2 SCOT Randomised Both Streamline C Non-randomised Interventional 1 Timing of Surgery after preoperative radiotherapy 6 vs 12 weeks Randomised Interventional 1 2 Limited number of patients meeting eligibilty criteria 27

28 Study Acronym / Short Title Randomisation? Study Design Recruitment Forecast Recruitment Comments re 2012/13 forecast Gastroenterology ChOPIN Non-randomised Both 0 10 Loss of PI interest study not opened MicroRNA Expression in Ulcerative Colitis and UCCancer Non-randomised Observational 6 CIRCCa Randomised Interventional 1 2 Early closure of the study DEPICT Non-randomised Interventional 3 2 DESKTOP III Randomised Interventional 0 3 Delay in opening of the study as there is no PI ICBP MODULE 4: Root causes of diagnosis and treatment delay in cancer Non-randomised Observational 2 ICON8: Weekly Chemotherapy in Ovarian Cancer Randomised Interventional No further suitable patients identified(bhr) Barts-Majority of Patients usually get referred from Queens but as the trial opened at Queens there is no referrals and No eligible patinets MAPPING Non-randomised Both 0 15 Due to lack of clinician with an ARSAC licence who can administer IMP meoc Randomised Interventional 1 PETROC/OV21 Randomised Interventional 3 2 PORTEC3 Randomised Interventional 8 8 RT3VIN Randomised Interventional 2 Haematological Oncology Group AML 16 Randomised Interventional 1 4 overestimated and study closed in May AML 17 Randomised Interventional AML 18 Pilot Non-randomised Both 3 6 Delay in opening of the study due to protocol amendment ARCTIC Randomised Interventional 1 4 Study closed early by sponsor Early Diagnosis of Invasive Aspergillosis Non-randomised Observational 16 LenaRIC Non-randomised Interventional 1 LI-1 Randomised Interventional 10 4 MAC UCBT Non-randomised Interventional 0 1 resource issues MARALL Non-randomised Interventional 1 4 overestimated recruitmement target MDSBio Non-randomised Observational Molecular Investigation of Haematopoietic Malignancy Non-randomised Observational MUK one Randomised Interventional 2 2 MUK six Non-randomised Interventional 3 Myeloma X Relapse (Intensive) Randomised Interventional 1 MYELOMA XI Randomised Interventional Overestimated recruitmement target NCRN132 - KW Bortezomib in Relapsed / Refractory Multiple 5 Myeloma Non-randomised Interventional 3 4 resource issues NCRN236 -Poma + Low-dose Dex vs High-dose Dex in Refractory/Relapsed & Refractory Multiple Myeloma Randomised Interventional 2 4 No further suitable patients identified NCRN237 extension study Pomalidomide For Subjects With Refractory Or Relapsed And Refractory MM Non-randomised Interventional 1 NCRN298 - Lenalidomide/dex +_ Elotuzumab in Relapsed or Refractory MM Randomised Interventional 3 4 No further suitable patients identified NCRN368: Panobinostat + Vidaza in MDS, chronic myelomonocytic CMML and AML Non-randomised Interventional 5 PADIMAC Non-randomised Interventional 13 5 RIC UCBT Non-randomised Interventional 0 1 resource issues SPIRIT 2 Randomised Interventional 6 16 Study closed early by sponsor TEAMM: Tackling early morbidity and mortality in myeloma Randomised Interventional Over estimated recruitment target UKALL 14 Randomised Interventional

29 Study Acronym / Short Title Randomisation? Study Design Recruitment Forecast Recruitment Comments re 2012/13 forecast Head and Neck Cancer Group NCRN363: Vandetanib in metastatic medullary thyroid carcinoma Randomised Interventional 3 SEND Randomised Interventional 8 12 Lung Cancer Group ADI-PEG 20 trial / ADAM Randomised Interventional CONVERT Randomised Interventional 3 5 No PI available ET Trial Randomised Interventional 3 11 Not opened due to pharmacy capacity at BHR IDEAL-CRT Non-randomised Interventional 0 3 Partly conflicts with ET- closed and reopened MALCS (Mesothelioma and Lung Cancer Study) Non-randomised Observational REST - Chest Irradiation in Extensive Disease Small Cell Lung Cancer Randomised Interventional 2 2 Lymphoma Group Health problems in long term survivors of lymphoma and leukaemia Non-randomised Observational 14 IELSG32 Randomised Interventional 0 5 Resource issues NCRN173-GADOLIN:Bendamustine + GA101 in Rituximab refractory, indolent NHL Randomised Interventional 4 2 NCRN178 - SABRINA - rituximab SC vs rituximab IV in untreated follicular lymphoma Randomised Interventional 3 NCRN198 - INOTUZUMAB OZOGAMICIN + RITUXIMAB IN RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NHL Randomised Interventional 2 1 NCRN246 GALLIUM - Untreated NHL Comparing Ga101 with Ritux followed By Ga101 Or Ritux maintenance Randomised Interventional 8 3 NCRN253 - CAL-101 Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents Non-randomised Interventional 2 NSHLG - National Study of Hodgkin's Lymphoma Genetics Non-randomised Observational Resource issues PACIFICO Randomised Interventional 0 4 Resource issues PAIRed Non-randomised Interventional 0 1 Resource issues R2W: Randomised phase 2 trial in Waldenstrom macroglobulinaemia Randomised Interventional 1 RATHL Randomised Interventional 11 8 R-CODOX-M/IVAC Non-randomised Interventional 6 2 REMoDLB Randomised Interventional 5 12 Resource issues Melanoma Group NCRN234 BOLT - LDE225 in patients with locally advanced or metastatic basal cell carcinoma Randomised Interventional 2 NCRN415: MELABIS Non-randomised Observational 17 AIP Non-randomised Observational 535 Study of haematology in newborns with Down syndrome Non-randomised Observational 6 Prostate Cancer Group MELCAP Non-randomised Interventional 9 PROMPTS Randomised Interventional 4 RADICALS (MRC PR10) Randomised Interventional STAMPEDE Randomised Interventional UK Genetic Prostate Cancer Study Non-randomised Observational Resource issues 29

30 Study Acronym / Short Title Randomisation? Study Design Recruitment Forecast Recruitment Comments re 2012/13 forecast Radiotherapy Group QUARTZ Randomised Interventional 0 4 RAPPER Non-randomised Observational SCORAD III Randomised Interventional 6 5 Few suitable patients identified but not intrested to participate in the trial and recruitment target is high Renal Cancer Group NCRN302 ROVER: DC-0980 VERSUS EVEROLIMUS IN mrcc PROGRESSED ON/FOLLOWING VEGF-TARGETED THERAPY Randomised Interventional 1 2 Resource issues SORCE Randomised Interventional 5 Group of ineligible patients at the end of recruitment period because of falling out of recruitment window after surgery resulting in unable to hit 8 the target STAR Standard vs Modified Drug Therapy in Renal Cancer Randomised Interventional 8 TRANSORCE (sub-study of SORCE) Randomised Interventional 7 ZEBRA Randomised Interventional 6 Surgery The HubBLe trial Randomised Interventional 2 Testis Cancer Group 111 Trial (formerly BEP 111) Non-randomised Interventional 3 4 Resource issues Quality of life of long-term survivors of testicular cancer 1 Non-randomised Observational 1 TRISST Randomised Interventional 9 5 Upper Gastro-Intestinal Cancer Group BILCAP Randomised Interventional 0 1 Changes to standard of care Cancer Research UK MK-0752 Non-randomised Interventional 3 CHR2845 in HCC Non-randomised Interventional 1 ESPAC-4 Randomised Interventional 1 4 No further suitable patients identified NCRN301 - ADI-PEG 20 + BSC vs Placebo + BSC in 2nd line advanced HCC Randomised Interventional 1 3 Resource issues PET-PANC Non-randomised Interventional 23 ST03 Randomised Interventional ViP Randomised Interventional 3 6 Delay in opening study 30

31 Appendix 2 - Table A: Studies which closed to recruitment nationally during reporting year Clinical studies Group NCRN Ref No. Agreed mcta target(number by date) Actual number of patients Recruited Comments Trust Table A:Studies which closed to recruitment nationally during reporting year Breast Cancer Group NCRN BLT Breast Cancer Group NCRN High number of screen failures BLT Breast Cancer Group NCRN ECMC study suspended because of resource issues BLT Haematology Oncology Group NCRN BLT Haematology Oncology Group NCRN BLT Haematology Oncology Group NCRN BLT Haematology Oncology Group NCRN BLT Colorectal Cancer Group NCRN Patient Population BLT Head and Neck Cancer Group NCRN BLT Renal Cancer Group NCRN BLT Lymphoma Cancer Group NCRN Research Nursing Capacity BLT Lymphoma Cancer Group NCRN Research Nursing Capacity BLT Melanoma Cancer Group NCRN BLT 31

32 Table B: Studies which closed to recruitment nationally during reporting year Clinical studies Group NCRN Ref No. Agreed mcta target(number by date) Actual number of patients Recruited Comments Trust Table B:Studies which open to recruitment nationally during reporting year Lymphoma Cancer Group NCRN BLT Lymphoma Cancer Group NCRN BHR Lymphoma Cancer Group NCRN BLT Lymphoma Cancer Group NCRN BLT Lymphoma Cancer Group NCRN Imaging Questionnaire to be completed to get site activated BLT Lymphoma Cancer Group NCRN 487 TBC 0 Lack of PET scanners BHR Lymphoma Cancer Group NCRN 487 TBC 0 Imaging Questionnaire to be completed to get site activated BLT Breast Cancer Group NCRN BLT Breast Cancer Group NCRN Delay in opening of the study BLT Breast Cancer Group NCRN Delay in opening of the study BLT Breast Cancer Group NCRN Research Nursing Capacity BHR Haematology Oncology Group NCRN Research Nursing Capacity BLT Haematology Oncology Group NCRN BLT Haematology Oncology Group NCRN 431 TBC 0 Study never opened BLT Upper GI Oncology Group NCRN Loss of PI intrest in the study BLT Melanoma Cancer Group NCRN BLT Melanoma Cancer Group NCRN Delay in opening of the study BLT 32

33 Appendix 3 - Follow Data by Tumour Group and Trust Tumour Group BLT BHR Homerton Newham Whipps Radiotheraphy Upper GI Cancer Group Lymphoma Cancer Group Gynaecological Cancer Group Urology Cancer Group Lung Cancer Group Haematology Cancer Group Breast Cancer Group

34 Appendix 4. Organogram for NELCRN 2012/