South East London Cancer Research Network

Transcription

1 South East London Cancer Research Network Annual Progress Report Written and Compiled by: Kerrie Montoute, Research Network Manager and Professor Stephen Devereux, Clinical Research Lead The South East London Cancer Research Network is part of the National Institute for Health Research Clinical Research Network, which supports research to make patients, and the NHS, better. 1

2 Table of Contents Page Executive Summary 3 Glossary of Terms 4 Research Profile 6 1. Organisation and Development of Network Background and Context Key Achievements in Integration with Cancer Service Network Interaction with other Research Infrastructure Financial Statement Portfolio and Recruitment Total Annual Network Recruitment 2001/2 to 2012/ SELCRN Portfolio Trust Performance Referral of Patients Follow-Up Workforce Infrastructure Development Patient and Public Involvement Network Initiatives 42 Appendices Appendix 1: Portfolio and Recruitment for Appendix 2: Delivery of NIHR Cancer Research Network Adopted Commercial Studies Appendix 3: SELCRN Follow-Up Activity Appendix 4: SELCRN Summary of Activity Sheet Appendix 5: SELCRN Staff Listing Appendix 6: List of Chief Investigators in the Network Appendix 7: Executive Summary of the Pan London and South East England Regional T&E Group Annual Report

3 Executive Summary The National Institute of Health Research (NIHR) South East London Cancer Research Network (SELCRN) was established in 2001 and is hosted by Guy s and St Thomas NHS Foundation Trust (GSTFT). The Network is comprised of four NHS Trusts Guy s and St Thomas NHS Foundation Trust (GSTFT), King s College Hospital NHS Foundation Trust (KCHFT), South London Healthcare NHS Trust (SLHT) and Lewisham Healthcare NHS Trust (LHT) together with research colleagues at St Christopher's Hospice, Greenwich and Bexley Community Hospice, Harris HospisCare with St Christopher s, Trinity Hospice, Demelza Hospice and academic partners King's College London (KCL), University of Greenwich and London Southbank University (LSBU). The Network serves a population of 1.5 million across the boroughs of Bromley, Bexley, Greenwich, Lambeth, Southwark and Lewisham. In 2012/13, the SELCRN was successful in recruiting 38% (2619 patients) with 7.8% (540 patients) recruited into Randomised Controlled Trials (RCTs) treating cancer and premalignant patients. The Network has also been successful in achieving the national clinical trials target for the third consecutive year in spite of funding and resource challenges. The Green Shoots Site Initiative has helped the Network to expand the NIHR Industry Badged/commercial trials portfolio and facilitated the opening of these studies at King s College Hospital NHS Foundation Trust, South London Healthcare NHS Trust and Lewisham Healthcare NHS Trust which is a great achievement particularly for the Acute NHS Trusts. Significant changes in the organisational landscape - the dissolution of the South East London Cancer Network (SELCN), emergence of the Integrated Cancer Systems and Academic Health Science Networks (AHSNs) as well as the organisational restructuring of South London Healthcare NHS Trust have occurred in the past year. In addition to this, the Network is now in a period of transition as it prepares for the development of the new Local Clinical Research Networks. The SELCRN Management Team has worked closely with key stakeholders to navigate through the changes and develop appropriate action plans to ensure the Network s strategic and operational objectives are achieved. The Network s staffing levels in 2012/13 remained stable at 91.7 WTE with 60 WTE working on NIHR cancer clinical trials. There has been a change in the source of funding for staff due to the reduced allocation of CLRN funding for cancer research teams in the Network; however, the stability of the cancer research infrastructure appears to be uncompromised. The SELCRN Management Team continues to work with key stakeholders to highlight the areas of improvement which include for example, performance against NIHR Higher Level Objectives, accuracy in conducting feasibility and forecasting patient recruitment and attendance at the SELCRN Steering Group Committee Meeting. In spite of the many challenges faced, the Network s ability to achieve the clinical trial targets over the past year would not be possible without the SELCRN Management Team s continuous engagement with key stakeholders and partnership working with Network Trusts. It is critical that this is maintained during this period of transition as stakeholder engagement is and will continue to be key in the development of the new Local Clinical Research Networks. 3

4 Glossary of Terms AHSN AHSC BRC CCL CLRN CSG ECMC GSTFT HLO ICC IMP KCHFT KCL LCA LCRN LHT LSBU NIHR NCRN POSCU PCRN PPI PTC RAG RCT R&D SGC Academic Health Science Network Academic Health Science Centre Biomedical Research Centre Children s Cancer and Leukaemia Comprehensive Local Research Network Clinical Study Group Experimental Cancer Medicine Centre Guy s and St Thomas NHS Foundation Trust Higher Level Objective Integrated Cancer Centre Investigational Medicinal Product King s College Hospital Foundation Trust King s College London London Cancer Alliance Local Clinical Research Network Lewisham Healthcare NHS Trust London South Bank University National Institute of Health Research NIHR Cancer Research Network Paediatric Oncology Shared Care Unit Primary Care Research Network Patient and Public Involvement Primary Treatment Centre Red, Amber, Green Randomised Controlled Trial Research and Development Steering Group Committee 4

5 Glossary of Terms SLHT SELCN SELCRN WTE South London Healthcare NHS Trust South East London Cancer Network South East London Cancer Research Network Whole Time Equivalent 5

6 SELCRN Research Profile Section # Indicator Network value Minimum National median and range 25th Percentile Median 75th Percentile Maximum 1 Network Population (NCRN) (millions) Cancer incidence (NCRN) Size 3 Number of new cancer patients treated/year (CWT data ) Funding 4 NCRN funding (Core + Research and Capability Funding) ( ) 676, , , , , ,220, Financial returns submitted on time (Y/N) Y All returns submitted on time 6 Spend to approved NCRN Core budget Y 0.00% Funding Management 7 Spend to approved Research and Capability Funding budget Y 0.00% 8 Total wte NCRN funded staff Total wte CLRN funded staff Total wte staff funded from RCF in Staffing 11 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 Portfolio 17 Response rate for Company Identified Site Reviews for NIHR CRN commercial studies Portfolio Delivery 18 HLO 1 Total number of participants recruited (NIHR cancer portfolio studies) Proportion of cancer patients recruited (NIHR cancer portfolio studies) (as % of NCRN cancer 19 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

7 24 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 closed nationally in HLO 2A Proportion of NIHR CRN commercial cancer study sites within the LRN delivering to time & target in % 0% 42% 55% 64% 75% 27 Proportion of studies attaining forecast recruitment 48% 28 Number of studies recruiting in that did not have a forecast Proportion of Cancer Research Network Peer Review Measures met 100% 30 Number of NCRI Clinical Studies Group Members Quality 31 Number of Chief Investigators for NIHR CRN portfolio studies 42 Workforce Development 32 Attendance at regional Workforce Development Group meetings 0% Patient & Public 33 Number of CLG members (Full and Associate members) Involvement 34 Proportion of survey respondents from across the network reporting having discussed research (Q27)

8 1. Organisation and Development of the Network 1.1 Background and Context The National Institute of Health Research (NIHR) South East London Cancer Research Network (SELCRN) was established in 2001 and is hosted by Guy s and St Thomas NHS Foundation Trust (GSTFT). The Network is comprised of four NHS Trusts Guy s and St Thomas NHS Foundation Trust (GSTFT), King s College Hospital NHS Foundation Trust (KCHFT), South London Healthcare NHS Trust (SLHT) and Lewisham Healthcare NHS Trust (LHT) together with research colleagues at St Christopher's Hospice, Greenwich and Bexley Community Hospice, Harris HospisCare with St Christopher s, Trinity Hospice, Demelza Hospice and academic partners King's College London (KCL), University of Greenwich and London South Bank University (LSBU). The Network serves a population of 1.5 million across the boroughs of Bromley, Bexley, Greenwich, Lambeth, Southwark and Lewisham. In terms of partnerships and alliances in the region, Guy s and St Thomas NHS Foundation Trust and King s College Hospital NHS Foundation Trust (KCHFT) form the Integrated Cancer Centre (ICC) and are also a part of King s Health Partners (KHP), the Academic Health Science Centre (AHSC). There have been three significant changes in the Network in 2012/13. Firstly, the South East London Cancer Network was dissolved on the 31 st March 2013 as part of the wider changes to the NHS which came into effect on the 1 st April Secondly, in September 2012, Professor Stephen Schey indicated that he would be stepping down from the Clinical Research Lead post on the 31 st March In light of this, the Clinical Research Lead post was advertised and interviews held. Professor Stephen Devereux, Consultant Haematologist at KCHFT was announced as the new Clinical Research Lead for the SELCRN and will be starting in the role from the 1 st April The third change is related to South London Healthcare NHS Trust as the Trust Special Administrator (TSA) was called in and, based on the recommendations of the TSA Report on South London Healthcare NHS Trust (SLHT), a decision has been made to dissolve the organisation. This has resulted in Lewisham Healthcare NHS Trust taking over the SLHT Queen Elizabeth Hospital, Woolwich site, and King s College Hospital NHS Foundation Trust taking over the SLHT Princess Royal University Hospital site in what is being described as a merger acquisition. These new arrangements will be effective from the 1 st October 2013 and the number of Trusts in the Network reduced from four (4) NHS Trusts to three (3) NHS Trusts. In 2012/13, there were 91.7 WTE with 60 WTE working on NIHR studies. When compared to 2011/12, the staffing levels have remained stable with very minor variances 1. The organisational structure of the SELCRN can be described as mixed due to the central and devolved line management arrangements of cancer research staff across the region. The SELCRN Lead Research Nurse is responsible for the line management of staff primarily in South London Healthcare NHS Trust and Lewisham Healthcare NHS Trust while research staff in the ICC are line managed by their respective organisations (i.e. Clinical Trials Manager/Lead Cancer Nurse). Cancer research staff in the ICC are funded primarily by NIHR Comprehensive Local Research Network (CLRN), Commercial, Trust and Grant funding, whereas staff in the Acute NHS Trusts are primarily funded by NIHR Cancer 1 There was an increase of 1 WTE in the overall staffing complement with an increase of 0.3 WTE dedicated to NIHR studies. 8

9 Research Network (NCRN) Core and Research Capability Funding (RCF). An outline of the funding source for staff in the Network is outlined in Section Key Achievements of the Network in In 2012/13, the SELCRN was successful in recruiting 38% (2619 patients) with 7.8% (540 patients) recruited into Randomised Controlled Trials (RCTs) treating cancer and premalignant patients. In light of the funding challenges faced by the research teams in 2012/13 and closure of high recruiting studies (for example REACT), the Network has been able to achieve both the national and RCT clinical trial targets for the third consecutive year. In addition to the development of the research infrastructure in the Acute NHS Trusts, the stability of the leadership and management structures and support of the R&D and Service Support Departments have been critical to this success. The SELCRN Research Team based at Lewisham Healthcare NHS Trust, under Principal Investigator Dr John O Donohue, was recognised by the Clinical Trials Office as the fastest and 2 nd highest recruiter to the SEAFOOD colorectal trial in the UK. As a result of this, the team was invited to contribute to the SEAFOOD Newsletter 2 to share the secrets of their success. With the launch of the NCRN s Green Shoot Site Initiative, the Network has made steady progress with the development of the NIHR Industry Badged/Commercial Studies portfolio with Dr Hartmut Kristeleit opening the PERTAIN (NCRN 335) study as well as successfully recruiting to the LUX-BREAST and SAFEHER studies. Dr Anna Rigg has also been successful in opening and recruiting to the PERUSE (NCRN354) study at KCHFT. At the time of writing this report, three (3) sites in the Network were selected to run the GSK Zoster studies in solid oncology and haematology studies at SLHT (PRUH and QEW Sites) and LHT. 1.3 Interaction with Cancer Service Network and emerging structures The dissolution of the Cancer Service Network, as a consequence of the restructuring of the NHS, has had an impact on the line management and accountability arrangements in the Network. With the SELCN Director, Nurse Director and Medical Director roles no longer in existence, alternative arrangements for line management and professional accountability have to be arranged. In the case of the Clinical Research Lead, there would be lines of accountability to the NIHR Cancer Research Network Coordinating Centre (NCRN CC) with the post holder undertaking line management responsibility for the SELCRN Manager until the new Local Clinical Research Networks come into effect on the 1 st April There are also plans for the SELCRN Lead Research Nurse to have lines of accountability within the nursing management structure within the Host Trust; however, this has not yet been finalised. The landscape for cancer services commissioning and provision in London has changed with the introduction of Integrated Cancer Systems (ICS) which has taken over the key responsibilities previously assigned to the Cancer Service Networks. The North and North East London Cancer Research Networks are now governed by London Cancer while the South East, South West and West London Cancer Research Networks are part of the 2 The article is scheduled to be published in April

10 London Cancer Alliance (LCA). In the past year, the Research Network Managers of the three (3) Networks within the LCA have worked on producing joint clinical trials portfolio and patient recruitment maps for the established Pathway Groups. The RNMs have also attended the established Pathway Group Meetings to inform the group of the NIHR Clinical Research Network performance management objectives as well as provide information on the impending changes in the NIHR Clinical Research Network. Another key message the RNMs have been communicating to the active groups 3 is around the nomination/recruitment of a Research Lead as it is believed this appointment would help them navigate in the new environment. The three (3) Cancer Research Networks in the LCA will be governed by two (2) Academic Health Science Networks (AHSNs) and by extension Local Clinical Research Networks (LCRNs). South East and South West London Cancer Research Networks will be governed by South London AHSN with West London covered by Imperial Health Partners AHSN. As the AHSNs are still in their early stages in their development, there has been very limited engagement with this emerging organisation with the SELCRN Manager attending only one stakeholder event in late It is expected that this engagement will be more robust in the new financial year when appointments have been confirmed and official designation of AHSNs known. In 2011/12, the service reconfigurations in the Network were centred on the transfer of the Bone Marrow Transplant (BMT) service from GSTFT to KCHFT; streamlining of the Urology MDT and chemotherapy administration for breast patients at SLHT. Discussions were also ongoing in relation to the transfer the breast and lung oncology service from GSTFT to LHT. With regard to the BMT service, this is still being embedded at KCHFT with clinical trials that require BMT have been opened at the site. The BMT Research Clinic is not yet operational; however, it is expected this service will be up and running in the new financial year. The streamlining of the Urology MDT between the PRUH and QEW Sites has facilitated in the development of clearer patient pathways and, for example, led to an increase in intranetwork patient referrals from SLHT (PRUH Site) to GSTFT and increase in patient recruitment to the STAMPEDE trial (See Section 2.5). The first phase of the move of the oncology service to LHT started in Year 12 with the lung service with plans for breast service to be moved in the next financial year. In terms of Children s Cancer and Leukaemia (CCL) studies, the SELCRN has two (2) Paediatric Oncology Shared Care Units (POSCUs) - King s College Hospital NHS Foundation Trust (Level 2 Unit) and South London Healthcare NHS Trust (QEW Site) (Level 1 Unit). The two Primary Treatment Centres (PTCs) are The Royal Marsden NHS Foundation Trust (RMH) and Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) for children under 1 year of age or for those weighing less than 10 pounds. RMH and GOSH fall under the North and South West Cancer Research Networks respectively. The Pan London and SE England Managers Group is used to address any issues with CCL studies in the London region particularly as it relates to any issues with the POSCUs. 3 It is important to highlight that the Pathway Groups are in varied stages of development. 10

11 The Network was required to conduct self-assessment in 2011/12 and achieved 100% compliance in all measures. However, attendance to the Steering Group Committee (Single Group) was raised as a serious concern. This has been highlighted to the respective Cancer Management/Senior Management Teams and there are plans for the Clinical Research Lead to have one-to-one meetings with the Research Leads. It is hoped that this would help to improve attendance to these meetings in 2013/ Interaction with other Research Infrastructure The SELCRN Manager continues to attend the Comprehensive Local Research Network (CLRN) London South Board Meetings. The SELCRN Management Team were also invited, along with the CLRN London South and Primary Care Research Network (PCRN) Greater London, to give a presentation to Professor Jonathan Montgomery, Chairman of the Health Research Authority (HRA) when he visited the organisation in October As part of the SELCN handover process, the SELCN Director and SELCRN Manager scheduled regular meetings with the GSTFT Assistant Director of R&D to highlight the upcoming organisational changes and the support the Network may require in the transition. The Host Trust has been very supportive during this process and has indicated that they would consider setting up an HR team specifically to deal with any issues arising out of the transition. The Network continues to engage with the NIHR Biomedical Research Centre on the South East London Consumer Research Panel for Cancer. The SELCRN PPI Lead and the BRC Patient and Public Involvement Coordinator are responsible for coordinating the work of the panel which continues to be jointly funded by both organisations. The activities of the panel have facilitated the development of a patient led service which helps to provide advice and support to researchers during the various phases and processes involved in research (See Section 4). 1.5 Financial Statement The core budget for the SELCRN was 566,084 with Research Capability Funding of 110,886 for the same period. As in 2011/12, the major risk to the Network s overall financial position is related to the freeze on the core funding allocation and the staff increments incurred every financial year. This continues to have an adverse impact on the amount the SELCRN Management Team is able to spend on both pay and non-pay and is reflected in the reduced number of staff (-2.8 WTE) funded by the Network s core allocation in 2012/13. The Network s Research Capability Funding (RCF) has been utilised to primarily fund Research Nurse and Clinical Trials Officer posts. The administration of commercial funding for the Integrated Cancer Centre is done via King s Health Partners Clinical Trials Office. The Network provides support for the set-up of NIHR Industry Badged/commercial studies in the Acute NHS Trusts and has established an invoicing system for the time NCRN funded staff work on these studies. This funding stream has been utilised primarily to support the training, education and staff development activities in the Network. 11

12 2. Portfolio and Recruitment Figure 2.1. Total Annual Network Recruitment 2001/2 to 2012/13 12

13 2.2 SELCRN Portfolio The NIHR cancer clinical trials portfolio in the SELCRN encompasses Phase I to Phase IV studies. Within the Network, there is an NIHR Biomedical Research Centre (BRC) and an Experimental Cancer Medicine Centre (ECMC). The majority of Phase I and Phase II clinical trials are conducted at GSTFT and KCHFT with the Acute NHS Trusts recruiting primarily to Phase III/IV studies. Studies in the common tumour groups breast, lung, colorectal, upper GI and haematology are offered to patients across the Network with clinical trials in bladder, brain, gynaecology, head and neck, renal and palliative care offered at the Integrated Cancer Centre. Patients requiring radiotherapy treatment are referred to GSTFT and are given the opportunity to enrol in radiotherapy clinical trials at this site (See Section 2.5). The SELCRN Clinical Trials Project Facilitator (CTPF) is responsible for setting up all NIHR non-commercial studies in the Network 4 and works closely with the Principal Investigators and R&D Departments to ensure studies are opened within the stipulated national guidelines. The Clinical Trials Officers and Administrators also work in conjunction with the CTPF to, for example, obtain signatures from Service Support Departments. The Network also utilises the EDGE Clinical Trials Management System 5 and has developed the pending trials tracker to keep updated on the status of trials in the pipeline. In 2012/13, the NIHR cancer clinical trials portfolio consisted of 186 studies 138 noncommercial and 48 commercial studies. Of the 186 studies on the portfolio, 95 studies (51%) were RCTs and 91 studies (49%) were non-rcts. There has been a 38% increase (26 studies) in the number of RCTs and 63% increase (35 studies) in non-rcts open to recruitment when compared to 2011/12. In Year 12, 151 studies (81%) were open and actively recruited to with 44.3% (67 studies) recruiting to at least 90% of forecast; 8% (12 studies) recruited 66-89% of forecast and 14% (21 studies) recruited to less than 65% of forecast. Fifty-one (51) studies (34%) did not have patient recruitment projections and as a result are not RAG rated. Overall, there has been a 20% increase in the number of studies open and recruiting in Year 12 when compared to the data for Year 11. For the third consecutive year, the SELCRN has been successful in achieving the national clinical trial targets with 38% (2619 patients) recruited to clinical trials, with 7.8% (540 patients) recruited to RCTs treating cancer and pre-malignant patients. Although the Network has seen a slight decrease in overall patient recruitment (13%) and recruitment to RCTs (7%), nationally the Network s performance is within the 75 th percentile region. The other indicators where the Network ranked within the 75 th percentile region relate to the proportion of cancer patients recruited; proportion of cancer patients recruited to intervention studies and the total number of participants recruited to NIHR CRN commercial cancer studies. As in Year 11, the number of commercial cancer studies that recruited to time and target (HLO2A) was 64%. This is clearly an area for improvement and will have to be addressed alongside the 48% attributed to studies obtaining forecast recruitment (down from 59% last year) and the number of studies (51) recruited to in Year 12 that did not have a forecast. The SELCRN Management Team has and will continue to highlight the importance 4 The SELCRN Lead Research Nurse and Clinical Trials Project Facilitator provide support in the set-up and costing of NIHR Industry Badged Studies to the Acute NHS Trusts. 5 As outlined in the SELCRN Work Programme 2012/13, the Network was upgraded to EDGE Version 2 in December

14 of conducting robust feasibility for studies to Research Leads and Principal Investigators as well as the wider research teams through quarterly R&D/Research Management Meetings. The NIHR Industry Badged clinical trials portfolio consisted of 38 open studies with 13 studies closed in year to recruitment. Of the 13 studies closed, 7 studies (54%) recruited to at least 90% of the target with the other 6 studies (46%) recruited to less than 65% of target with three (3) studies having zero recruitment. With the open studies, 10 studies (27%) recruited to 90% of the target; 3 studies (8%) recruited to 66%-89% of target and 21 studies (57%) recruited to less than 65% of the target. It is important to highlight that this data relate to performance in the recruitment year and not the length of the study so the study can still recruit to the targets set before the trial closes. The majority of NIHR Industry Badged Studies are open in the Integrated Cancer Centre (ICC), the SELCRN Management Team continues to emphasise to key stakeholders the importance of ensuring studies recruit to time and target. The clinical trials portfolio in the SELCRN ranges from Phase I to Phase IV. Within the Network, there is an NIHR Biomedical Research Centre and an Experimental Cancer Medicine Centre (ECMC). The majority of Phase I and Phase II clinical trials are conducted at GSTFT and KCHFT with the Acute NHS Trusts recruiting primarily to Phase III/IV studies. Studies in the common tumour groups breast, lung, colorectal, upper GI and haematology are offered to patients at all sites across the Network with clinical trials in bladder, brain, gynaecology, head and neck, renal and palliative care to name a few offered at the Integrated Cancer Centre. The NIHR breast cancer portfolio is large and diverse covering all aspects of breast cancer, including screening. In Year 12, there were 33 studies open to recruitment with 12 (36%) being RCTs and 21 studies (64%) classified as non-rctsl. Of the 33 studies open to recruitment, 15 studies (45%) were recruited to at least 90% of forecast; three (3) studies (9%) recruited to at least 66-89% of forecast and three (3) studies (9%) recruited to less than 65% of forecast. In terms of recruitment, 1022 patients (151 patients RCTs; 871 non-rcts) have been recruited to breast cancer clinical trials in 2012/13. The highest recruiting RCT breast trials were POETIC, PERSEPHONE and OPPORTUNE. The breast surgical teams in the Network have done exceptionally well this year in terms of their recruitment to studies. In particular, Mr Jonathan Roberts, Consultant Breast Surgeon at KCHFT was the highest recruiter to the POETIC study and Professor Arnie Purushotham at GSTFT to the OPPORTUNE Study. The PERSEPHONE trial is open across four (4) sites 6 in the Network and has recruited 27 patients in the past year. In terms of non-rcts, the three top recruiting studies were PERSONALISING SCREENING WITH MAMMOGRAM CAD AND RISK DATA; BOCS (FBCS) and ICICLE. When examining the performance of the breast tumour group nationally, the number of intervention studies open and the recruitment appear to be in the mean, with the number of studies and recruitment to non-intervention studies in the 75 th percentile (See Table 2.2). Recruitment to colorectal clinical trials portfolio has not shown much improvement from Year 11 as there are no NCRI portfolio clinical trials in advanced colorectal cancer in either 1 st or 2 nd line. There were 7 studies 3 RCTs and 4 non-rcts open to recruitment in Year 12. Overall, the colorectal tumour group recruited 111 patients with 16 patients recruited to 6 SLHT (PRUH Site) was the highest recruiter to this study. 14

15 RCTs and 95 patients recruited to non-rcts. As in Year 11, the top recruiting RCT study was SCOT with NSCCG being the highest recruiting non-rct study. It is expected that patient recruitment in the colorectal tumour group would improve in the next recruitment year when the FOXTROT 7 (primary colon cancer neoadjuvant study), FOCUS-4 and ADD ASPIRIN trials are opened. In particular, the FOCUS-4 trial as a 1 st line study is expected to be a good recruiter. In February 2013, the Colorectal Research Lead hosted a Colorectal Protocol Half-Day where the study was discussed in depth and the patient referral pathways for the study discussed. At GSTFT, there will be collaboration with the ECMC to function as a Level 1 site with SLHT (QEW Site) and LHT being allocated as Level 2 sites. Nationally, in terms of the number of studies and recruitment to both intervention and non-intervention studies, the Network s performance is significantly below the mean. The Upper GI Tumour Group experienced modest recruitment in 2012/13 when compared to 2011/12 due to the closure of the BOSS study. The lack of a palliative study for oesophagogastric cancer has also had an adverse impact on the portfolio and recruitment. Seventyeight (78) patients were recruited in Year 12, with 38 patients recruited to RCTs and 40 to non-rct studies. Of the fourteen (14) studies open to recruitment, six (6) studies recruited to at least 90% of the target with top recruiting RCTs being the TACE-2 8, STO3, NCRN 104 (BIBF) and ABC03. Recruitment to NIHR Industry Badged studies in HCC has performed well in the past financial year and as with the colorectal tumour group, it is expected that pending trials in oesophago-gastric, pancreatic, neuro-endocrine and hepatocellular cancer will help to improve Upper GI recruitment in the next financial year. When compared with the national data, the performance of the Upper GI tumour group is also significantly below the mean for both intervention and non-intervention studies. Patient recruitment for NIHR lung clinical trials continues to be below the national average due to the gap in that national portfolio in small cell lung cancer studies and the limited number of studies open in the Acute NHS Trusts. In Year 12, this tumour group recruited 29 patients with the top recruiting studies being ADAM (RCT) and MALCS (non-rct). The Network remains one of the top recruiters to the current national first line NSCLC trial (ET), although recruitment to this became more complicated with standard-of-care EGFR mutation testing competing for clinicians' attention in this setting. The aim for this tumour group is to maintain a broad mix of trials across the thoracic oncology indications, in particular, in trials where standard treatments are lacking. There are plans to open the STOMP trial in the next financial year and it is hoped that this would be a good recruiting study as the IMP is oral therapy combined with standard chemotherapy. The haematology tumour group performed well in Year 12 with total recruitment of 223 patients in the Network. Of the 30 studies opened, 21 were RCTs recruiting 76 patients with 9 studies being non-rcts recruiting 147 patients. Nationally, the group was in the 75 th percentile in terms of number of intervention studies open to recruitment and was above the mean in recruitment to intervention studies. However, the group ranked significantly below the mean in non-intervention recruitment. Overall, the top recruiting RCTs were the TEAMM, MUK ONE and AML 17 studies with the top non-rct performing studies being THE CAUSES OF CLONAL BLOOD CELL DISORDERS; CLEAR and MDSBIO. The lymphoma tumour group also maintained its performance when compared with Year 11 7 This study will be opened at SLHT (QEW Site) and LHT. 8 KCHFT is one of only three (3) sites in the UK recruiting to the TACE-2 trial 15

16 recruiting 133 patients. The clinical trials portfolio consisted of 14 studies (7 RCTs and 7 non-rcts) with the REMODL-B, NSHLG and NCRN 246 studies recruiting to at least 90% of forecasted recruitment. Nationally, the group scored above the mean for the number of non-intervention studies open to recruitment but performed below the mean in the number of intervention studies open, intervention recruitment and non-intervention recruitment. When compared with the other Tumour Groups in the Network, the haematology and lymphoma tumour groups continue to perform well. 16

17 Table 2.2 Table of Network Portfolio and Recruitment of Participants benchmarked to National Performance

18 18

19 Please note the studies listed in Table 2.2 do not correlate to Appendix 1 due to differences with national and local classifications. Studies that did not recruit in Year 12 are not factored in the above table (for example, gynaecology studies). 19

20 2.3 Trust Performance Figure 2.3 Annual Participant Recruitment by Trust (2010/11, 2011/12, 2012/13) 20

21 Guy s and St Thomas NHS Foundation Trust Guy s and St Thomas NHS Foundation Trust has the largest clinical trials portfolio in the Network. In 2012/13, the Trust had an NIHR cancer clinical trials portfolio consisting of 103 studies (51 RCTs; 52 non-rcts). In Year 12, GSTFT recruited 1342 patients to NIHR cancer clinical trials representing an increase of 14% from Year 11. Of the 1342 patients recruited, 297 patients (22%) were recruited to RCTs; 1045 patients recruited to non-rcts (78%) 9. When compared to Year 11, the Trust has increased patient recruitment to RCTs by 27%; non-rcts by 11%. Overall, GSTFT has increased its patient recruitment to NIHR cancer clinical trials by 14% (See graph below). In 2012/13, the GSTFT R&D Department applied the national formula for the weighting of CLRN patient recruitment (1:3:14 for Large observational: observational: interventional) and allocated funding accordingly. This resulted in a 500k decrease in funding from 2011/12. This prompted a restructure of the team which led to an agreed plan to remove a number of Senior Clinical Research Nurse posts from within the team and increase the number of nonclinical, multi-skilled Clinical Trial Co-ordinator roles. This would allow the expensive clinical resource to focus purely on the support of the patients throughout their time on study whilst the co-ordination and administrative duties could be undertaken by the CTCs. In addition to this, small teams were to be amalgamated into larger ones, allowing greater cross cover across tumour groups, more support for new staff and critical mass for those senior staff with line management responsibilities. Through liaison with the GSTFT R&D department slotting in opportunities were identified in advance for all staff that would be placed at risk following implementation of the proposed change so no staff member would face redundancy as a result. The changes were implemented from 1 st October 2012 and despite an anticipated 9 Please note this does not include recruits classified under Other. 21

22 drop in both activity and team morale, no adverse effects were seen. Quality and efficiency were monitored throughout the change and implementation of the new structure and no changes in performance were measured at any point. Overall, 46.3 WTE supported recruitment to cancer research in Year 12 with 20.6 WTE working on NIHR studies. In Year 12, there was an increase in patient recruitment in the Brain, Breast, Bladder, Head and Neck, Melanoma, Palliative and Supportive Care, Prostate, Renal and Testis Tumour Groups (See CSG Pie Chart). The brain tumour group has performed very well this year and has seen an 81% increase in patient recruitment. As the neuro-oncology service is run across the ICC, increased patient recruitment to brain studies in the Network can be attributed to the hard work and dedication of Dr Lucy Brazil (Consultant Clinical Oncologist, GSTFT) and Mr Keyoumars Ashkan (Consultant Neurosurgeon, KCHFT) and their respective Research Teams. The breast tumour group has seen an increase of 38% in overall recruitment which is primarily due to the breast surgical group and genetics studies. In 2012/13, the Department of Breast Surgery at GSTFT had ten (10) studies on the portfolio, three (3) of which were RCTs. All studies are Investigator led or commercial collaborative studies focused on a mixture of device related, CTIMP and observational studies. The top recruiting studies run by the breast surgical group were the SENTIMAG MULTICENTRE STUDY; OPPORTUNE and the 70+ STUDY. Recruitment to POETIC at GSTFT was held off due to the OPPORTUNE study being prioritised as it was seen as a groundbreaking window study. The PLACE study also experienced problems with recruitment in Year 12 due to differences in interpreting clinical lymphodema. As in 2011/12, BOCS (formerly known as FBCS) and EMBRACE were the top non-rct studies in the breast tumour group. 22

23 The tumour groups that showed a decrease in patient recruitment when compared to Year 11 were the Colorectal, Haemato-Oncology, Lung, Lymphoma, Psychosocial Oncology and Upper GI Tumour Groups. In the case of the colorectal tumour group, three (3) trials have been open to recruitment at GSTFT FOXFIRE, SCOT and ARISTOTLE. FOXFIRE is a niche trial that recruits effectively for patients who attend GSTFT for chemotherapy but has limited recruitment from across the Network. It would not be possible to open this study at other sites within the Network. SCOT is a long running adjuvant study which continues to recruit slowly despite the critical question being asked. ARISTOTLE is also recruiting well below its potential and is the 2 nd chemo-radiation trial in recent years to recruit poorly. The primary obstacle is that appropriate patients will be identified at all sites within the Network however; patients usually prefer to have surgery locally with the diagnostic team. There are plans to open this study at SLHT (QEW Site) and KCHFT in the next financial year which should help to boost patient recruitment. The lack of portfolio studies can also be attributed to the decrease in recruitment to the Psychosocial Oncology and Lung Tumour Groups. GSTFT continues to benefit robust intra and inter-network patient referrals across which are detailed in Section 2.5. The intra-network patient referrals originate primarily from the Acute NHS Trusts. In 2012/13, inter-network patient referrals came from hospitals in the Kent and NHS Trusts in London, Birmingham and Devon to name a few. Follow up of patients continues to be a significant workload for the GSTFT Cancer Research Team and a breakdown of this can be found in Section 4. The SELCRN Management Team schedules meetings with the GSTFT Cancer Management Team every two months which are also attended by a representative from the R&D Department. Discussions at the meeting are centred on portfolio management, patient recruitment to targets, data management, HR and recruitment issues. These meetings will continue in the next financial year and are also used to communicate key updates on the NIHR transition programme. 23

24 King s College Hospital NHS Foundation Trust In 2012/13, the NIHR cancer clinical trials portfolio at King s College Hospital NHS Foundation Trust (KCHFT) consisted of 43 studies 19 RCTs and 22 non-rcts across twelve (12) tumour groups. The Trust recruited 284 patients 121 RCTs and 163 non-rcts in Year 12 which represents a 6% increase in overall recruitment when compared to Year 11 (See Graph Below). Patient recruitment to RCTs has decreased by 20% however; recruitment to non-rcts has increased by 42%. As in 2011/12, the top recruiting Tumour Groups were Breast, Palliative and Supportive Care and Haemato-Oncology. The development of the breast clinical trials portfolio at KCHFT has been very successful especially with pre-surgical studies such as POETIC and EPHOS-B. Led by Principal Investigator Jonathon Roberts KCHFT recruited 26 patients into the POETIC study and was the highest recruiting site. Dr Anna Rigg, was successful in securing the PERUSE (NCRN 335) study as a New Investigator under the Green Shoots site initiative. The study has recruited two (2) patients to date and is expected to achieve the study target of five (5) patients. Other top recruiting intervention studies were CLEAR (Haematology), GALA 5 (Brain), TACE-2 (Liver) and the DEVELOPMENT OF KCH BREATHLESSNESS SERVICE (Palliative Care). In terms of non-rcts, the highest recruiters were the PERSONALISING SCREENING WITH MAMMOGRAM CAD AND RISK DATA STUDY (Breast), TOMMY (Breast), NBT (Brain), and NSHLG (Lymphoma) (See CSG Pie Chart). In terms of staffing, KCHFT has 22.9 WTE working in cancer research with 16.9 WTE working on NIHR Studies. The Haematology Clinical Trials Unit at KCHFT recruits to both NIHR Industry Badged and non-commercial studies and currently has a portfolio of 21 trials. There are currently eight (8) studies in setup and overall there has been a 20% increase in the number of studies open to recruitment when compared to Year 11. In the past year, twelve (12) members of staff worked on NIHR studies; however there have been a number of staff changes and 24

25 periods of short staffing due to sickness and maternity absences, staff leave as well as pending appointments of new staff. Despite these challenges, overall recruitment to the NIHR portfolio has increased by approximately 50% in the Haemato-oncology group with a 30% increase in the lymphoma group when compared to the previous year. Commercial trials have also risen by 50% in haematology and three-fold in lymphoma which is helpful as the group faced a 50k reduction in CLRN funding 10. Although the activity based funding for the group was affected, the haematology research team remains committed to achieving national clinical trial targets and recruiting to rare and Phase I trials. As with GSTFT, KCHFT benefits from intra-network referrals particularly with the Brain, Haematology and Lymphoma Tumour Groups (See Section 2.5). The Palliative Care Research Team works across KCHFT and GSTFT and has had a successful recruitment year. All palliative care studies are locally developed investigator led studies which have been adopted onto the NIHR portfolio. In 2012/13, a larger number of studies have been a mix of diagnoses (both cancer and non-cancer conditions) or specifically addressing non cancer conditions (since there is less palliative care research in this population). The Band 7 Research Nurse post, initially funded through the SELCRN s bid to the CLRN in 2009/10, has now been made substantive 11 and the Band 6 Research Nurse continues in post until January This has enabled a greater number of MDM s and clinics to be attended to screen patients and identify potential participants for the clinical 10 The KCHFT R&D Department utilises the same performance based model as the CLRN. Total recruitment in haematology has increased due primarily to observational rather than interventional studies which has had an adverse impact on the allocation. 11 This post is now funded via the Trust s CLRN allocation. 25

26 teams to approach. The Research Nurses have been instrumental in coordinating with other sites as required, particularly for the Myeloma and IARE studies. 26

27 South London Healthcare NHS Trust South London Healthcare NHS Trust (SLHT) covers three (3) hospitals Queen Elizabeth Hospital, Woolwich; Princess Royal University Hospital, Bromley and Queen Mary s Hospital, Sidcup. In Year 12, there were twenty (20) NIHR cancer clinical trials 13 RCTs and 7 non-rcts open across five (5) Tumour Groups. The Trust has recruited 170 patients 88 patients in RCTs; 81 patients in non-rcts; 1 patient in other non-rcts (See Graph Below). The top recruiting Tumour Groups in Year 12 were the Breast, Haemato- Oncology and Lymphoma. The Trust has seen a decrease in patient recruitment to both RCTs (38%) and non-rcts (63%) which is primarily due to the closure of studies such as REACT, BOSS, ACHEW, GLACIER and ICICLE. Patient recruitment to the NSCCG study has also been adversely affected due to the change in the eligibility criteria which requires patients to have a family history of colorectal cancer. The top recruiting RCT studies in 2012/13 were the POETIC, REACT, PERSEPHONE and TEAMM studies with top recruiting non-rcts being the ICICLE, NSCCG, CLEAR and NSHLG Studies. Dr Hartmut Kristeleit was selected as one of the New Investigators under the Green Shoots Site Initiative and has been instrumental in opening both NIHR Industry Badged (PERTAIN NCRN 335) and commercial studies (LUX-BREAST; SAFEHER) at the site. As a result of this, he has been selected as the Chief Investigator for the GSK Zoster-028 Study (NCRN 426) which will be open to recruitment in the next financial year. The Consultant Haematologists and Research Team 12 at the SLHT (PRUH Site) have had a very successful year and were the top recruiters to the TEAMM, RIALTO and SPIRIT 2 studies in the 12 The SELCRN secured funding from the CLRN London South to employ a Band 6 Research Nurse to work on haematology and lymphoma studies at KCHFT and SLHT (PRUH Site). 27

28 Network. The Consultant Haematologists have also been very proactive and have secured two (2) NIHR Industry Badged Studies in the past year. Dr Corinne Delord was successful in opening and recruiting the GILEAD 116 (NCRN 375) and Dr Anil Lakhani has also been selected as the Principal Investigator for the GSK Zoster-039 Study (NCRN 436) at the SLHT (PRUH Site) (See CSG Pie Chart). The SELCRN Management Team has worked closely with the SLHT R&D Department to develop the research infrastructure at the Trust. With the planned restructuring of the two active research sites QEW and PRUH being taken over by Lewisham Healthcare NHS Trust and King s College Hospital NHS Foundation Trust respectively, the priority for the SELCRN Management Team would be to ensure the restructuring does not adversely impact on the work done over the past four years by the Principal Investigators, R&D and Service Support Departments. The Network will also continue to work with Principal Investigators to explore additional studies that can be opened at the respective sites as the merger acquisition would present further opportunities for treating patients closer to home. Part of these discussions would also be centred on the resources supporting cancer clinical trials at the site which currently stands at 13.5 WTE (See Appendix 4). South London Healthcare NHS Trust continues to be the major contributor to patient referrals to the Integrated Cancer Centre and there needs to be an exploration of the studies that can be opened and recruited at these sites. 28

29 Lewisham Healthcare NHS Trust In Year 12, Lewisham Healthcare NHS Trust had a portfolio of 15 NIHR cancer clinical trials across eight (8) Tumour Groups. The Trust has recruited 83 patients 31 into RCTs; 31 into non-rcts and 21 into other non-rcts in 2012/13 (See Graph below). The Trust has seen a decrease in patient recruitment to RCTs (38%) and non-rcts (24%). The decrease in patient recruitment is due primarily to key studies closing in the past year. The highest recruiting Tumour Groups at LHT in Year 12 were the Colorectal, Gastroenterology and Lymphoma Tumour Group (See CSG Pie Chart). LHT is the highest recruiter in the Network to the SCOT and SEAFOOD studies. The success of these studies can be attributed to the hard work of the Research Team led by Principal Investigators Dr George Mikhaeel and Dr John O Donohue. Dr Naheed Mir, one of the New Investigators selected as part of the Green Shoots site initiative was also selected for the GSK Zoster-039 Study (NCRN 436) which is due to start recruiting in the new financial year. There are also plans to open the FOXTROT trial and the ADD ASPIRIN study which should also help to boost patient recruitment at the site. As with South London Healthcare NHS Trust, the SELCRN Management Team has worked closely with the R&D Department in developing the research infrastructure on site. With the planned merger acquisition with the SLHT (QEW Site), the SELCRN Management Team will have discussions with the respective teams to ensure resources dedicated to cancer research are maintained. In Year 12, there were 3.4 WTE of staff dedicated to recruiting to NIHR cancer clinical trials (See Appendix 5). The SELCRN Management Team is also keen to explore new opportunities for developing the NIHR cancer clinical trials portfolio particularly in light of the transfer of the breast and lung chemotherapy service to LHT. In the past year, the site has been able to open the ET trial and it is hoped that the breast clinical trials portfolio could be developed further in the upcoming year. 29

30 The SELCRN Management Team is committed to helping the Trust within developing its clinical trials portfolio. With the expansion of the Trust in the next financial year, this work will remain a top priority. The Network organises Research Meetings at the Trust which facilitate discussions with key stakeholders about the clinical trials portfolio, performance of studies as well as resources on site. These meetings are well attended and have also been utilised as a forum to discuss the NIHR transition programme. 30

31 Table 2.4 SELCRN Patient Referral Activity The table below provides a comprehensive overview of the intra and inter-network patient referral system in the Network. Study Acronym CSG Recruiting site Referring site No of patients referred Total number of referred patients No of referred patients subsequently recruited Total no of patients recruited in 2012/13 Percentage of total recruitment LaMB Bladder Cancer Group GSTFT SLHT QEW % KCHFT Maidstone Hospital % KCHFT Medway Maritime Hospital % GALA-5 Brain Tumour Group KCHFT SLHT PRUH % KCHFT GSTFT KCHFT Tunbridge Wells Hospital % GSTFT KCHFT % 6 40 NBT Brain Tumour Group GSTFT SLHT PRUH 1 0 0% KCHFT Darent Valley Hospital % FAST-Forward Breast Cancer Group GSTFT SLHT PRUH % 11 8 GSTFT SLHT QEW % IMPORT HIGH Breast Cancer Group GSTFT SLHT PRUH % SentiMAG Multicentre Trial Breast Cancer Group GSTFT KCHFT 4 0 0% GSTFT LHT 9 0 0% TARGIT Breast Cancer Group GSTFT KCHFT % GSTFT KCHFT % TNT Breast Cancer Group GSTFT LHT % GSTFT SLHT QMS % BRCL Breast Cancer Group GSTFT KCHFT % 4 11 GSTFT LHT % ICICLE Breast Cancer Group GSTFT SLHT QMS % 70+ Study Breast Cancer Group GSTFT LHT % GSTFT KCHFT % GSTFT LHT % MBEDL Breast Cancer Group GSTFT SLHT QMS % 31

32 SCOT FOXFIRE NSCCG ACT CHOP-OR CLEAR DEC-MDS NCRN269 NCRN440 PADIMAC RIC UCBT Study Acronym CSG Recruiting site Referring site The Causes of Clonal Blood Cell Disorders No of patients referred Total number of referred patients No of referred patients subsequently recruited Total no of patients recruited in 2012/13 Percentage of total recruitment Colorectal Cancer GSTFT KCHFT 3 0 0% 4 3 Group GSTFT SLHT PRUH 1 0 0% Colorectal Cancer GSTFT KCHFT 3 0 0% 4 2 Group GSTFT SLHT QEW % GSTFT KCHFT % Colorectal Cancer Group GSTFT LHT % GSTFT SLHT PRUH % Immunology and KCHFT GSTFT % 3 2 Inflammation KCHFT LHT % KCHFT Maidstone Hospital % 2 2 Oncology Group KCHFT Medway Maritime Hospital % KCHFT GSTFT % Oncology Group KCHFT Kent & Canterbury % KCHFT LHT % KCHFT East Kent Hospitals % 2 9 Oncology Group KCHFT SLHT QEW % Oncology Group GSTFT SLHT QEW % KCHFT Brighton and Sussex % KCHFT GSTFT % Oncology Group Oncology Group Oncology Group Oncology Group KCHFT Heatherwood and Wexham Park % KCHFT Maidstone Hospital % KCHFT Medway Maritime Hospital % KCHFT SLHT PRUH % KCHFT SLHT QEW % GSTFT SLHT QEW % KCHFT GSTFT % GSTFT KCHFT % 32

33 Study Acronym CSG Recruiting site Referring site ADI-PEG 20 trial / ADAM EORTC MAPPING Lung Cancer Group Lung Cancer Group No of patients referred Total number of referred patients No of referred patients subsequently recruited Total no of patients recruited in 2012/13 Percentage of total recruitment GSTFT KCHFT % GSTFT North Devon District Hospital % GSTFT SLHT PRUH 1 GSTFT KCHFT 1 0 0% 5 1 GSTFT SLHT PRUH % ET Trial Lung Cancer Group GSTFT LHT % IDEAL-CRT Lung Cancer Group GSTFT KCHFT % GSTFT LHT % GSTFT SLHT PRUH 1 NCRN225 Lung Cancer Group GSTFT SLHT PRUH % GSTFT KCHFT % GSTFT LHT % NCRN410 Lung Cancer Group GSTFT SLHT PRUH % GSTFT SLHT QMS 1 0 0% GSTFT Royal National Orthopaedic Hospital 1 0 0% MALCS Lung Cancer Group GSTFT SLHT QEW % NCRN246 GALLIUM Lymphoma Group KCHFT SLHT PRUH % NCRN422: ALCANZA Lymphoma Group GSTFT Milton Keynes Hospital % NSHLG Lymphoma Group GSTFT LHT % KCHFT Conquest Hospital % 26 KCHFT SLHT PRUH % NCRN322 TERRAIN Prostate Cancer Group GSTFT SLHT PRUH % RADICALS (MRC PR10) Prostate Cancer Group GSTFT KCHFT % STAMPEDE UK Genetic Prostate Cancer Study (UKGPS) Prostate Cancer Group Prostate Cancer Group GSTFT KCHFT % GSTFT LHT % GSTFT SLHT PRUH % GSTFT SLHT QEW 2 GSTFT SLHT PRUH 1 0 0% % GSTFT SLHT QEW % 14.3% 5.1% 33

34 FLT PET Study Acronym CSG Recruiting site Referring site Radiotherapy Group 111 Trial (formerly BEP 111) Testis Cancer Group TRISST UKGTCS ABC-03 Testis Cancer Group Testis Cancer Group UGI Cancer Group No of patients referred Total number of referred patients No of referred patients subsequently recruited Total no of patients recruited in 2012/13 Percentage of total recruitment GSTFT SLHT PRUH % 2 7 GSTFT LHT % Chelsea and Westminster GSTFT % Hospital GSTFT SLHT PRUH % 2 6 GSTFT SLHT QEW % GSTFT SLHT PRUH % GSTFT SLHT QEW % GSTFT University Hospital Birmingham % GSTFT KCHFT % GSTFT LHT % GSTFT SLHT PRUH 1 BILCAP UGI Cancer Group GSTFT KCHFT % ESPAC-4 UGI Cancer Group GSTFT KCHFT % NCRN104 NCRN214 BAGPAC UGI Cancer Group UGI Cancer Group GSTFT KCHFT % 2 7 GSTFT SLHT PRUH % GSTFT KCHFT % 3 4 GSTFT SLHT QEW % NCRN333 - RADIANT-4 UGI Cancer Group GSTFT KCHFT % ST03 UGI Cancer Group GSTFT Darent Valley Hospital 1 0 0% GSTFT KCHFT 1 0 0% GSTFT SLHT PRUH % GSTFT SLHT QEW % GSTFT SLHT QMS 1 ViP UGI Cancer Group GSTFT KCHFT % OCCAMS UGI Cancer Group GSTFT KCHFT % GSTFT Maidstone Hospital % GSTFT SLHT PRUH % GSTFT SLHT QEW % GSTFT SLHT QMS % 16.7% 6.7% 34

35 2.5 Follow-Up Effective follow-up of patients is actively being addressed by various Tumour Groups in the Network. At GSTFT, all patients recruited to adjuvant/neo-adjuvant breast oncology trials who have completed the active phase of a particular trial are reviewed in the Monthly Research Followup Clinic. Approximately fifteen (15) patients are seen each month and all trial related data are completed and dispatched in a timely fashion. The Network has also developed a Nurse Led Follow-Up Form to help with the management of patients on follow-up (See Section 5). A summary of follow up by Tumour Group can be found in Table 2.5 with a further breakdown utilising the NCRN Patient Status Definitions found in Appendix 3. Table 2.5 Follow-Up by Tumour Group Primary CSG GSTFT KCHFT LHT SLHT (PRUH Site) SLHT (QEW Site) Network Total Breast Cancer Group Colorectal Cancer Group Gynae Gastroenterology 0 Oncology Group Head and Neck Cancer Group Lung Cancer Group Lymphoma Group Upper Gastro-Intestinal Cancer Group Total

36 3. Workforce 3.1 Infrastructure The organisational structure of the SELCRN changed from being centralised to mixed due to the restructuring in 2009/10. The mixed model of management is attributed and reflective of the central and devolved line management arrangements of cancer research staff across the Network. In Year 12, there were 91.7 WTE employed working in cancer research with 60 WTE dedicated to NIHR studies. In terms of the staffing profile, when compared to 2011/12, there has been an increase in the WTE in the Management Team (+1.2 WTE) and Clinical Trials Practitioner/Officer categories (+25 WTE) with a decrease shown the Service Support (-4.6 WTE); Data Manager (-2.6 WTE) and Administrator (-1 WTE) categories. It is important to highlight that the large increase in the Clinical Trials Practitioners/Officers is due to the coding of all the Band 5 Clinical Trials Coordinators and Clinical Trials Officers in this category as opposed to previous years where they were split between the Data Manager and Clinical Trials Assistant categories. In Year 12, staff categorised under the Data Manager category tend to be Band 4 Clinical Trials Administrators and Band 3 Data Managers (See Table 3.1). Table 3.1 Overview of SELCRN Staffing Profile Staff Role WTE WTE spent on NIHR Studies Percentage of Total Management Team % Research Nurses % Clinical Trials Practitioner/Officer % Service Support % Data Manager % Administrator 3 3 3% Total % In spite of the funding cuts faced by the GSTFT Cancer Research Team and KCHFT Haematology Research Team, the overall manpower of the Network has remained relatively stable. However, there has been a significant increase in the Other funding category which is an amalgamation of Commercial, Trust and Grant funding sources. It would not be unreasonable to suggest that staff previously funded by the CLRN are now being funded by Other funding sources due to the significant increase (+17 WTE) which represents 62% of the in 2012/13 as opposed to 43% in 2011/12 (See Table 3.1.2). The number of staff funded by the Network has also been adversely affected (-2.9 WTE) which is due to the fixed core allocation of the Network and increasing staff increments. In the past year, the SELCRN Management Team has had to utilise its RCF allocation and submit bids to the 36

37 CLRN London South for funding in order to ensure sites were properly resourced. In 2012/13, the SELCRN was successful in obtaining strategic funding for one (1) Band 6 Research Nurse to support haematology studies at KCHFT and SLHT (PRUH Site). The Network was also successful in obtaining CLRN Contingency Funding for 6 months for two (2) Band 6 Research Nurses and one (1) Band 5 Clinical Trials Officer post. Table Source of Staff Funding for NIHR Activities Funding Source WTE Percentage of Total Staff NCRN % NCRN FSF 6 6% CLRN 18 20% Other % Total %. In Year 12, the Network continued to fund the Highly Specialist Pharmacist (also referred to as the SELCRN Research Pharmacist) for two (2) days per week. The Network has found this post to be very useful in providing support to the Clinical Trials Pharmacists in the Network. The SELCRN Research Pharmacist attends all the Network R&D/Research Meetings which are also attended by the Clinical Trials Pharmacists on site. As outlined in the SELCRN Work Programme for , providing support with preparation of clinical trials documentation 13 as well as supporting quality assurance functions. Quality assurance work streams continue to be a high priority and the SELCRN Pharmacist works closely with the Clinical Trials Pharmacists to ensure SOPs are up-to-date and quality systems for the storage and management of Investigational Medicinal Products (IMPs) are fit for purpose and adhere to sponsor requirements. In addition to the SELCRN Research Pharmacist post, the SELCRN continues to fund the SELCRN PPI Lead post (See Section 4) and contribute to Pan London and South East England Regional Training Facilitator post. 3.2 Workforce Development New members of staff joining the SELCRN are required to complete the SELCRN In-House Induction Programme which covers a range of topics such as Discussing Trials With Patients; Preparing for MHRA Inspections and Audits and Understanding Research Governance to name a few. In 2012/13, three (3) new topics Tracking Concomitant Medication, Interpretation of Patients Visit Schedules and Research and Development Operations at Site were added to the programme. In addition to the In-House Programme, members of staff are also given a personalised Induction Folder which contains information about the Network and other pertinent documents related to the individual s role. With the migration of EDGE Version 2 in December 2012, the Network was involved with training all EDGE users on the system. Users had to be trained before being able to have access to the system. In order to address this, training sessions were held in the Network s 13 To ensure studies open within the HLO requirements 37

38 Offices which were conducted by the Clinical Trials Project Facilitator and Clinical Trials Coordinator with oversight by the SELCRN Manager. The entire process for the migration and training of users took approximately six (6) weeks. Within the training programme, provisions are made for new members of staff as well as those who require refresher training. With the success of the Daily Guide for Research Nurses and in order to help in the cover of staff in cases of annual leave and sickness absence, members of the team developed a universal CRF diary and a Clinical Trials Officer/Clinical Trials Administrator Handbook. The guidelines outlined in the handbook have helped to create a more efficient and simple way to hand over work to other members of staff with regard to data capture and completion. This has facilitated less disruption to the day-to-day running of key data management functions when team members were unavailable. These guidelines have also been deemed very useful in helping new members of staff understand their role and that of others in the team to help in the capturing and completion of study data. The SELCRN Lead Research Nurse (LRN) is the Network Training Link and is the representative on the Pan London and South East England Regional Training and Education Group. In addition to this, the LRN is also a member of the NCRN Senior Research Professionals Planning Group; the GSTFT Senior Research Nurses Group and the UKCRF Pan London Group. The LRN was also invited to present at the 14 th Annual Clinical Trials Supply Conference which was held in February 2013 and gave a presentation on the topic Communication for Logistical Transportation of Biological Samples. The presentation was very well received and the LRN was asked to present again at another event in May The Network continues to share the pre-screening trackers with colleagues across the Network and with pharmaceutical colleagues. As a result of this, the LRN was invited by York Teaching Hospital Foundation Trust to give a presentation 14 on the utilisation of the trackers. 14 This presentation will take place in April

39 4. Patient and Public Involvement The Patient and Public Involvement work streams in the Network are aligned to the NIHR Clinical Strategic Aim (No. 1 - to engage with patients, carers and the wider public as partners in all aspects of research delivery) and the NCRN s Impact Strategic Theme. The SELCRN continues to fund the SELCRN Patient and Public Involvement Lead who is responsible for facilitating and coordinating the work of the SELCRN PPI Group and is the Network s representative on the South East London Consumer Research Panel (SELCRP) for Cancer. The SELCRN PPI Group is a partnership group comprised of patients, Research Nurses and other healthcare professionals and works on activities to raise awareness about clinical trials, improve access to clinical trials and the patient experience of clinical trials including providing good information, and support is available for patients and their families. Members of the SELCRN PPI Group also attend the SELCRN Steering Group Committee Meetings in line with Peer Review measures. Performance of the Network Trusts in the three (3) questions in the National Cancer Patient Experience Survey (NCPES) was varied. For the first question (Q. 27), all NHS Trusts in the Network performed above the national average with GSTFT performing above the Network average. With Q.28, three of the four Network Trusts all performed above the Network average but slightly below the national average. With the third question, two out of the four Network NHS Trusts were above both the national and network average. The results of the NCPES for the Network were timely and aligned to the survey developed and administered by the SELCRN PPI Group. The focus of the survey was to better understand the needs of patients/carers undertaking clinical trials and to improve their experience at point of care. The survey was successfully administered by the Research Nurses at KCHFT, SLHT (PRUH and QEW Sites) and LHT and approximately eighty (80) responses were received. Due to the positive feedback obtained from the survey, the SELCRN PPI Lead and Group have started work on developing a Patients Supporting Patients (PSP) project. The group made an application to Macmillan Cancer Support to pilot the PSP project which was successful with plans to launch the project in the next financial year. 60% Q27: Taking part in research discussed with patient. Highest score for all trusts: 62% 50% 40% 30% 20% 10% 0% South London Healthcare NHS Trust Lewisham Healthcare NHS Trust King's College Hospital NHS Foundation Trust Guy's and St Thomas' NHS Foundation Trust Trust score National average Network average 39

40 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Q28: Patient glad to have been asked about taking part in cancer research. Highest score for all trusts: 100% South London Healthcare NHS Trust Lewisham Healthcare NHS Trust King's College Hospital NHS Foundation Trust Guy's and St Thomas' NHS Foundation Trust Trust score National average Network average 70% Q29: Patient would like to have been asked about taking part in cancer research. Highest score for all trusts: 72% 60% 50% 40% 30% 20% 10% 0% South London Healthcare NHS Trust Lewisham Healthcare NHS Trust King's College Hospital NHS Foundation Trust Guy's and St Thomas' NHS Foundation Trust Trust score National average Network average The South East London Consumer Research Panel for Cancer is a collaboration between SELCRN and the NIHR Biomedical Research Centre (BRC). The panel is now well established and comprised of trained core members who undertake a range of work advising and supporting researchers with design of studies and patient information. This group works to ensure that there is a user perspective into all stages of the research pathway which 40

41 includes for example, the design, feasibility and recruitment strategies of studies. In 2012/13, group members have provided feedback and ideas on eleven (11) research proposals which include a first-in-man trial for head and neck cancer and a study to explore Whole Body MRI Staging of Oesophageal Cancer. In March 2013, the group hosted its second open evening for researchers which was well attended by clinicians, healthcare professionals and academic researchers. 41

42 5. Network Initiatives Development of Nurse-Led Follow-Up Forms Active patient follow-up continues to impact on clinic space at some Trusts, for example, SLHT (PRUH Site) and KCHFT. The Network has explored implementing Nurse-led clinics; however, this initiative has not been feasible at these Trusts due to varying Trust Policies. As a result, a Nurse-led Follow-up Form was developed which is on trial at KCHFT (Breast Tumour Group) for three (3) months. The form is utilised by the Research Nurses working alongside Principal Investigators (PIs) and they take the lead on the non-clinical assessments to ease the clinic congestion thereby cutting down on the time the patients spend with PIs who still have to see non-trial patients. It is evident that non-clinical trial patients make up the majority of the clinic lists therefore once the PIs time with trial patients is minimised, this would decrease the time trial patients spend in Oncology Outpatients Clinic and reduce congestion. Quality Assurance Work Stream Long Term Scheduling Tool The Lead Research Nurse formed a Quality Assurance Working Group which is in the process of developing a long term scheduling tool which will be used to plan resources staff, equipment, rooms, laboratory time, medical cover etc. The tool is useful for feasibility and assessing capacity and gives a view of the weeks ahead. This has been implemented due to past issues with medical cover at the Acute NHS Trusts particularly when the PIs are on annual leave. The tool therefore helps the Research Teams to plan in advance which patients to bring into clinic on the days when the PIs are not available. This also ensures trial patients receive the quality of care from medical staff who have received appropriate training on the trial/s. Quality Assurance Work Stream Data Clarification Tool Following the occurrence of missing data on Source Documents and issues with data management, the SELCRN Lead Research Nurse and Clinical Trials Officers and Administrators developed a Data Clarification Tool which would be provided to the respective PIs and Research Nurses to support them in providing the required trial data following patient consultations. The tool is aimed at improving CRF completion and also reduces the number of queries received from Trials Offices. It is also hoped that the tool will improve the quality of the data being captured. In 2012/13, there was also an increase in the development of study specific source documentation being created which also made the missing data more transparent than before and also meant that more accurate data were in turn captured at the source. Cancer Database Audit In an effort to identify reasons for the lack of patient recruitment in haematology studies, a decision was made to conduct an audit of the cancer database at one of the Network sites on a trial basis. The audit was completed on the 16 th April The data are extracted on patients that are diagnosed with specific haematological malignancies and then compared against our current patient recruitment figures in the respective disease groups to obtain a clear idea on the number of patients who failed to enter trials. This process has now helped us to re-focus on improving our strategies on patient identification at point of care. This may 42

43 have an impact on the communication strategies employed or facilitate the creation of a formal communication structure between the Research Nurses, Ward Nurses and Clinical Nurse Specialists. 43

44 Appendix 1: Portfolio and Recruitment for (Compared against Forecast Recruitment) LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation Study Design Recruitment CLARET 0 1 Age and Ageing Geriatric oncology liaison pilot intervention Closed in follow up Forecast Recruitment CCRN (supported by NCRN, PCRN) Non randomised Interventional Bladder Cancer Group BOLERO Closed in follow up NCRN (supported by CCRN, PCRN) Randomised Interventional 10 Bladder Cancer Group LaMB Open NCRN Randomised Interventional 7 5 Brain Tumour Group Feasibility of 5 ALA and Carmustine wafers for Glioblastoma (GALA 5) Open NCRN Non randomised Interventional 11 5 Brain Tumour Group NBT Open NCRN (supported by CCRN) Non randomised Observational Breast Cancer Group Abiraterone Acetate in Advanced or Metastatic Breast Cancer Open NCRN Non randomised Interventional 3 2 Breast Cancer NCRN (supported by Group AFFECT Open CCRN) Non randomised Observational 3 5 Breast Cancer Group An Investigation of Breast Cancer Related Lymphoedema Open NCRN Non randomised Observational 11 7 Breast Cancer Group ARTemis Closed in follow up NCRN Randomised Interventional 4 2 Breast Cancer Group Barriers to early diagnosis with breast cancer Open NCRN Non randomised Observational 27 5 Breast Cancer NCRN (supported by Group BOCS (formerly FBCS) Open CCRN) Non randomised Observational Breast Cancer NCRN (supported by Group COPE Open CCRN) Non randomised Observational 4 Breast Cancer Group EPHOS B Open NCRN Randomised Interventional 3 3 Breast Cancer Group Exploring the needs of breast cancer survivors after treatment Open NCRN Non randomised Observational 7 Breast Cancer Group FAST Forward Open NCRN Randomised Interventional 8 10 Breast Cancer Group Genome Profiling in ER Negative Breast Cancer Open NCRN Non randomised Observational 8 5 Breast Cancer NCRN (supported by Group GLACIER Closed in follow up CCRN) Non randomised Observational 5 44

45 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment Forecast Recruitment Breast Cancer Group ICICLE Open NCRN (supported by CCRN) Non randomised Observational Breast Cancer Group IMPORT HIGH Open NCRN Randomised Interventional 6 5 Breast Cancer Group Management of breast cancer for women aged 70+ in Greater Manchester Open NCRN Non randomised Observational Breast Cancer Group Breast Cancer Group Breast Cancer Group Multifrequency Bioimpedance in the Early Detection of Lymphoedema Open NCRN Non randomised Observational NCRN354 PERUSE: Pertuz+Traz +Taxane in 1st line HER2+ advanced Br ca Open NCRN Non randomised Interventional 2 NCRN409 BELLE2: Fulvestrant + P13k inhibitor in ER+/Her2 MTORi naïve adv /MBC refractory to an AI Open NCRN Randomised Interventional 1 Breast Cancer Group NCRN463 TDM1 in Her2+ advanced / MBC Open NCRN Non randomised Interventional 3 Breast Cancer NCRN (supported by Group NeoExcel Open CCRN) Randomised Interventional 0 3 Breast Cancer Group OPPORTUNE Open NCRN Randomised Interventional 10 5 Patient perception of success and Breast Cancer benefit in self care BCRL Group treatment. Open NCRN Non randomised Observational 7 Breast Cancer Group Persephone Open NCRN Randomised Interventional Personalising screening with mammogram CAD and risk data: Pilot study Closed in follow up NCRN Non randomised Observational 355 Breast Cancer Group Breast Cancer Group POETIC Open NCRN (supported by CCRN) Randomised Interventional Breast Cancer Group REACT Randomised European Celecoxib Trial Closed in follow up NCRN Randomised Interventional Breast Cancer Group SentiMAG Multicentre Trial Open NCRN Non randomised Interventional 78 Breast Cancer Group TARGIT Closed in follow up NCRN Randomised Interventional 5 Breast Cancer Group TNT Open NCRN Randomised Interventional

46 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment Breast Cancer Group Breast Cancer Group Breast Cancer Group Breast Cancer Group Forecast Recruitment TOMMY trial:comparison of TOMosynthesis with digital MammographY Closed in follow up NCRN Non randomised Interventional TPI in vivo study in breast cancer and sentinel lymph nodes Open NCRN Non randomised Both 6 Variation in Treatment of Older Women with Operable Breast Cancer Open NCRN Non randomised Observational 3 Young onset breast cancer decision tool for informed Closed follow up surgical choice complete NCRN Non randomised Observational 5 12 Children's Cancer and Leukaemia FACT study Open NCRN (supported by CCRN) Non randomised Observational 11 Colorectal Cancer Group Bowel Screening Follow Up Study Open NCRN Non randomised Observational 21 Colorectal Cancer NCRN (supported by Group CORGI Open CCRN) Non randomised Observational 5 Colorectal Cancer Group FOXFIRE Open NCRN Randomised Interventional 2 5 Colorectal Cancer NCRN (supported by Group New EPOC Closed in follow up CCRN) Randomised Interventional 0 6 Colorectal Cancer NCRN (supported by Group NSCCG Open CCRN) Non randomised Observational Colorectal Cancer Group PROSPECT Improving the prediction of metastatic disease in primary colorectal cancer Open NCRN (supported by CCRN) Non randomised Interventional 1 30 Colorectal Cancer Group SCOT Open NCRN Randomised Both The seafood Polyp Prevention CCRN (supported by Gastroenterology Trial Open NCRN) Randomised Interventional 12 Genetics Communication About Hereditary Cancer Open Genetics EMBRACE Open CCRN (supported by NCRN) Non randomised Observational 10 CCRN (supported by NCRN) Non randomised Observational Oncology Group AML 16 Closed in follow up NCRN Randomised Interventional 1 8 Oncology Group AML 17 Open NCRN Randomised Interventional

47 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment Oncology Group ARCTIC Closed in follow up NCRN Randomised Interventional 3 5 Oncology Group Oncology Group CHOP OR: Study of CHOP with Ofatumumab in patients with Richter's Syndrome Open NCRN Non randomised Interventional 2 1 Forecast Recruitment CLEAR: CLL Empirical Antibiotic Regimen Open NCRN Non randomised Interventional Oncology Group CLL210 (CamDexRev) Suspended NCRN Both Interventional 0 3 Oncology Group COSMIC Version 2.0 Open NCRN Randomised Interventional 0 3 Oncology Group DEC MDS Open NCRN Non randomised Interventional 9 5 Oncology Group EBV associated NK/T cell malignancies Open NCRN Non randomised Observational 0 1 Oncology Group MAJIC Open NCRN Randomised Interventional 11 Oncology Group MDSBio Open NCRN Non randomised Observational 24 9 Oncology Group MUK one Closed in follow up NCRN Randomised Interventional 5 4 Oncology Group Myeloma X Relapse (Intensive) Closed in follow up NCRN Randomised Interventional 1 4 Oncology Group MYELOMA XI Open NCRN Randomised Interventional 0 13 NCRN191 POMALIDOMIDE IN SUBJECTS WITH MPN Oncology Group ASSOCIATED MYELOFIBROSIS Closed in follow up NCRN Randomised Interventional 1 1 Oncology Group Oncology Group NCRN237 extension study Pomalidomide For Subjects With Refractory Or Relapsed And Refractory MM Closed in follow up NCRN Non randomised Interventional 1 NCRN269 placebo vs Siltuximab in High risk Smoldering Multiple Myeloma Open NCRN Randomised Interventional 1 Oncology Group NCRN289 JAKARTA Closed in follow up NCRN Randomised Interventional 4 47

48 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment NCRN306 SAR in polycythemia vera or ess. thrombocythemia resistant/intolerant to Oncology Group hydroxyurea Open NCRN Randomised Interventional 7 Oncology Group Oncology Group Oncology Group NCRN357 Bortezomib + Dexamethasone +/ LY in Myeloma Open NCRN Randomised Interventional 1 NCRN375: CAL Rituximab for Previously Treated CLL Open NCRN Randomised Interventional 1 NCRN440: Ibrutinib versus ofatumumab in relapsed/refractory CLL or SLL Open NCRN Randomised Interventional 9 Oncology Group PADIMAC Open NCRN Non randomised Interventional 16 4 Oncology Group PT1 Closed in follow up Forecast Recruitment NCRN (supported by CCRN) Randomised Both 2 6 Oncology Group REVEAL Open NCRN Randomised Interventional 0 2 Oncology Group RIAltO Open NCRN Randomised Interventional 3 4 Oncology Group RIC UCBT Open NCRN Non randomised Interventional 4 1 Oncology Group SPIRIT 2 Closed in follow up NCRN Randomised Interventional 6 7 Oncology Group Oncology Group TEAMM: Tackling early morbidity and mortality in myeloma Open NCRN Randomised Interventional The Causes of Clonal Blood Cell Disorders Open NCRN (supported by CCRN) Non randomised Observational Oncology Group UKALL 14 Open NCRN Randomised Interventional 0 2 Head and Neck Cancer Group ART DECO Open NCRN Randomised Interventional 1 2 Head and Neck Cancer Group BoHEMIaN Study Open NCRN Non randomised Interventional 1 Head and Neck NCRN (supported by Cancer Group HOPON Open CCRN) Randomised Interventional

49 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment Head and Neck Cancer Group NCRN319 E7080 in refractory thyroid cancer Closed in follow up NCRN Randomised Interventional 2 Head and Neck NCRN (supported by Cancer Group PET NECK study Closed in follow up CCRN) Randomised Interventional 3 2 Immunology and Inflammation A phase III randomised study to investigate the use of adoptive cellular therapy (ACT) Open CCRN (supported by NCRN) Randomised Interventional 2 Lung Cancer Group ADI PEG 20 trial / ADAM Open NCRN Randomised Interventional 7 5 Lung Cancer Group EORTC MAPPING Open NCRN Randomised Interventional 1 2 NCRN (supported by Lung Cancer Group ET Trial Open CCRN) Randomised Interventional 3 5 Lung Cancer Group IDEAL CRT Open NCRN Non randomised Interventional 7 8 Lung Cancer Group Lung Cancer Group Lung Cancer Group Lymphoma Group Lymphoma Group MALCS (Mesothelioma and Lung Cancer Study) Open NCRN Non randomised Observational 7 5 NCRN225 EGF cancer vaccine in inoperable, late stage (IIIB/IV) NSCLC patients Open NCRN Randomised Interventional 1 NCRN410: Efficacy and Safety of MetMAb + Erlotinib in MET positive NSCLC Advanced Disease Open NCRN Randomised Interventional 3 Developing a model of best practice for Cutaneous T cell lymphoma Forecast Recruitment Closed follow up complete NCRN Non randomised Observational EORTC Lenalidomide maintenance: Phase III v1.0 Open NCRN Randomised Interventional 1 8 Lymphoma Group IELSG32 Open NCRN Randomised Interventional 0 3 Lymphoma Group MiniAllo Open NCRN Non randomised Interventional 0 1 Lymphoma Group NCRN246 GALLIUM Untreated NHL Comparing Ga101 with Ritux followed By Ga101 Or Ritux maintenance Open NCRN Randomised Interventional 3 2 Lymphoma Group NCRN422: ALCANZA Open NCRN Randomised Interventional 1 Lymphoma Group NSHLG National Study of Hodgkin's Lymphoma Genetics Open NCRN Non randomised Observational Lymphoma Group PACIFICO Open NCRN Randomised Interventional

50 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment Lymphoma Group PAIRed Open NCRN Non randomised Interventional 0 1 PET after 2 cycles in NHL (substudy) Lymphoma Group Closed in follow up NCRN Non randomised Interventional 0 3 Lymphoma Group RATHL Closed in follow up NCRN Randomised Interventional 4 9 Lymphoma Group R CODOX M/IVAC Closed in follow up NCRN Non randomised Interventional 0 1 Lymphoma Group ReACH Forecast Recruitment Closed follow up complete NCRN Non randomised Interventional 0 1 Lymphoma Group REMoDLB Open NCRN Randomised Interventional 11 6 Melanoma Group NCRN398 IMAGE: Observational Study in Patients with Unresectable or Metastatic Melanoma Open NCRN Non randomised Observational 8 Melanoma Group NCRN415: MELABIS Open NCRN Non randomised Observational 7 Melanoma Group NCRN423: BRAF+MEK vs vemurafenib in BRAF mutated unresctable or advanced melanoma Open NCRN Randomised Interventional 1 Metabolic and Endocrine (not diabetes) AIP Open CCRN Non randomised Observational 9 Nervous System Disorders Non Malignant Haematology Non Malignant Haematology Evaluation of MET PET in the diagnosis of NF1 MPNST HLA Epitope Matched Platelet Transfusion Study Study of haematology in newborns with Down syndrome Open Open Open Palliative & Supportive Care Group The IARE Study Open CCRN (supported by NCRN) Non randomised Interventional 4 CCRN (supported by NCRN) Randomised Interventional 1 CCRN (supported by NCRN) Non randomised Observational 8 NCRN (supported by CCRN) Non randomised Observational Prostate Cancer Group Histoscanning for detection and localisation of prostate cancer Open NCRN Non randomised Observational 3 Prostate Cancer NCRN (supported by Group IMPACT Open CCRN) Non randomised Observational 5 5 Prostate Cancer Group Prostate Cancer Group Impact of Zoledronic acid and IL2 on gamma delta T cells Open NCRN Non randomised Observational 6 Managing hot flushes and night sweats following prostate cancer Open NCRN Randomised Interventional 47 50

51 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment Forecast Recruitment NCRN322 TERRAIN: MDV3100 Prostate Cancer Group (ASP9785) vs. Bicalutamide Metastatic Prostate Cancer Open NCRN Randomised Interventional 9 Prostate Cancer NCRN (supported by Group RADICALS (MRC PR10) Open CCRN) Randomised Interventional Prostate Cancer Group STAMPEDE Open NCRN Randomised Interventional 46 5 Prostate Cancer UK Genetic Prostate Cancer NCRN (supported by Group Study Open CCRN) Non randomised Observational Psychosocial Oncology Group Psychosocial Oncology Group Psychosocial Oncology Group Radiotherapy Group ADVOCATE Closed follow up complete NCRN Non randomised Observational Biliary Tract Cancer QoL Validation Open NCRN Non randomised Observational 4 5 Quality of life in multiple myeloma and follicular lymphoma Open NCRN Non randomised Observational FLT PET to assess tumour proliferation during radical radiotherapy Open NCRN Non randomised Interventional 7 10 Radiotherapy Group RAPPER Open NCRN Non randomised Observational 10 Renal European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy Open CCRN (supported by NCRN) Randomised Interventional 1 2 Renal Salivary Markers for Renal Cancer Open CCRN (supported by NCRN) Non randomised Observational 55 Respiratory Development of KCH breathlessness service Respiratory NMES in Severe COPD Open Closed follow up complete CCRN (supported by NCRN) Randomised Interventional CCRN (supported by NCRN) Randomised Interventional 14 Testis Cancer Group 111 Trial (formerly BEP 111) Open NCRN Non randomised Interventional 1 2 Testis Cancer Group The UK Genetics of Testicular Cancer Study Open NCRN (supported by CCRN) Non randomised Observational Testis Cancer Group TRISST Open NCRN Randomised Interventional 6 5 The Teenage and Young Adults Clinical Studies Development Group BRIGHTLIGHT: The 2012 TYA Cancer Cohort Study Open NCRN Non randomised Observational 3 51

52 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment Forecast Recruitment Upper Gastro Intestinal Cancer Group ABC 03 Closed in follow up NCRN Randomised Interventional 5 5 Upper Gastro Intestinal Cancer Group BILCAP Open NCRN (supported by CCRN) Randomised Interventional 1 2 Upper Gastro Intestinal Cancer Group ESPAC 4 Open NCRN Randomised Interventional 1 1 Upper Gastro Intestinal Cancer Group NCRN104 BIBF 1120 vs sorafenib in Adv HCC Open NCRN Randomised Interventional 7 1 Upper Gastro Intestinal Cancer Group Upper Gastro Intestinal Cancer Group Upper Gastro Intestinal Cancer Group NCRN214 BAGPAC: BAY gemcitabine in locally advanced inoperable or metastatic pancreatic ca Closed in follow up NCRN Non randomised Interventional 4 NCRN256 Axitinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma therapy Closed in follow up NCRN Randomised Interventional 0 1 NCRN301 ADI PEG 20 + BSC vs Placebo + BSC in 2nd line advanced HCC Open NCRN Randomised Interventional 2 Upper Gastro Intestinal Cancer Group NCRN333 RADIANT 4 Open NCRN Randomised Interventional 2 Upper Gastro Intestinal Cancer Group Upper Gastro Intestinal Cancer Group Upper Gastro Intestinal Cancer NCRN379 BEZ235 vs. everolimus in Advanced Pancreatic Neuroendocrine Tumours Open NCRN Randomised Interventional 2 OCCAMS Evaluation of revised staging system for GOJ adenocarcinoma Open Group PET PANC Closed in follow up Upper Gastro Intestinal Cancer Group ST03 Open Upper Gastro Intestinal Cancer Group TACE 2 Open NCRN (supported by CCRN) Non randomised Observational NCRN (supported by CCRN) Non randomised Interventional 6 12 NCRN (supported by CCRN) Randomised Interventional 6 5 NCRN (supported by CCRN) Randomised Interventional

53 LRN Short Name Primary CSG Study Acronym / Short Title Active Status Owning Organisation Randomisation? Study Design Recruitment Forecast Recruitment Upper Gastro Intestinal Cancer Group ViP Open NCRN Randomised Interventional Key Green if the study recruited to at least 90% forecast Amber if the study is recruited to 66 89% of forecast Red if the study is recruited less than 65% forecast Black indicates when the study has no/zero recruitment White indicates where studies have recruitment but no forecast 53

54 Appendix 2: Delivery of NIHR Clinical Research Network adopted Commercial Studies Table A: Studies which closed to recruitment nationally during the reporting year Clinical Studies Group NCRN Ref No. Agreed target (RAG report) (Number by date) Actual Number of patients recruited to date Comments Oncology Group NCRN NCRN NCRN NCRN NCRN NCRN NCRN Head and Neck Cancer Group NCRN Lung Cancer Group NCRN Lymphoma Group NCRN Upper Gastro Intestinal Cancer Group NCRN NCRN NCRN

55 Table B: Remaining studies open to recruitment nationally during the reporting year Clinical Studies Group NCRN Ref No. Agreed target (RAG report) (Number by date) Actual Number of patients recruited to date Comments Breast NCRN NCRN NCRN NCRN 409 TBC 1 NCRN Colorectal Cancer Group NCRN Gynaecological Cancer Group NCRN Oncology Group NCRN NCRN NCRN NCRN NCRN NCRN NCRN NCRN NCRN NCRN Lung Cancer Group NCRN NCRN NCRN NCRN NULL NCRN 378a 3 0 NCRN

56 Clinical Studies Group NCRN Ref No. Agreed target (RAG report) (Number by date) Actual Number of patients recruited to date Lymphoma Group NCRN NCRN NCRN 487 TBC 0 Melanoma Group NCRN NCRN NCRN NCRN 442 TBC 0 Prostate Cancer Group NCRN NCRN Upper Gastro Intestinal Cancer Group NCRN NCRN NCRN NCRN NCRN Comments Key Green if the study recruited to at least 80% forecast Amber if the study is recruited to 66 79% of forecast Red if the study is recruited less than 65% forecast White indicates where studies have recruitment but no forecast 56

57 Appendix 3: SELCRN Follow-Up Activity Primary CSG Study Acronym / Short Title Active Status Randomisation Type of follow Up GSTFT KCHFT LHT Number of patients on Follow Up 2012/13 SLHT (PRUH Site) SLHT (QEW Site) Breast Cancer Group ARTemis Closed in follow up Randomised Breast Cancer Group attom Closed in follow up Randomised Breast Cancer Group Azure Closed in follow up Randomised Breast Cancer Group Beatrice Closed in follow up Randomised Breast Cancer Group EMILIA Closed in follow up Randomised Breast Cancer Group EPHOS B Open Randomised Breast Cancer Group IBIS Closed in follow up Randomised Breast Cancer Group Breast Cancer Group Management of breast cancer for women aged 70+ in Greater Manchester Multifrequency Bioimpedance in the Early Detection of Lymphoedema Open Open Nonrandomised 1 1 Network Total Nonrandomised Breast Cancer Group NeoExcel Open Randomised Breast Cancer Group NeotAnGo Closed in follow up Randomised Breast Cancer Group OPPORTUNE Open Randomised Breast Cancer Group Option Closed in follow up Randomised Breast Cancer Group Persephone Open Randomised Breast Cancer Group POETIC Open Randomised Breast Cancer Group POSH Closed in follow up Randomised Breast Cancer Group REACT Randomised European Celecoxib Trial Closed in follow up Randomised Breast Cancer Group SentiMAG Multicentre Trial Open Nonrandomised Breast Cancer Group SoFEA Closed in follow up Randomised

58 Primary CSG Study Acronym / Short Title Active Status Randomisation Type of follow Up GSTFT KCHFT LHT Number of patients on Follow Up 2012/13 SLHT (PRUH Site) SLHT (QEW Site) Breast Cancer Group TACT1 Closed in follow up Randomised Breast Cancer Group TACT2 Closed in follow up Randomised Breast Cancer Group tango Closed in follow up Randomised Breast Cancer Group TARGIT Closed in follow up Randomised Breast Cancer Group TNT Open Randomised Breast Cancer Group Zice Closed in follow up Randomised Colorectal Cancer Group PICCOLO Closed in follow up Randomised Colorectal Cancer Group QUASAR 2 Closed in follow up Randomised Colorectal Cancer Group SCOT Open Randomised Gynaecology 6MP Open Nonrandomised Gynaecology CHORUS Closed in follow up Randomised Gynaecology ICON6 Closed in follow up Randomised Gynaecology ICON7 Closed in follow up Randomised Gynaecology Meoc Open Randomised Gynaecology PORTEC 3 Open Randomised Gynaecology SAPPROC Closed in follow up Randomised Oncology Group AML 15 Closed in follow up Randomised Oncology Group AML 16 Closed in follow up Randomised Oncology Group AML 17 Open Randomised Oncology Group ARCTIC Closed in follow up Randomised Oncology Group CHOP OR: Study of CHOP with Ofatumumab in patients with Richter's Synd Open Nonrandomised Network Total 58

59 Primary CSG Oncology Group Study Acronym / Short Title Active Status Randomisation CLEAR: CLL Empirical Antibiotic Regimen Open Oncology Group MDSBio Open Type of follow Up GSTFT KCHFT LHT Number of patients on Follow Up 2012/13 SLHT (PRUH Site) SLHT (QEW Site) Network Total Nonrandomised Nonrandomised Oncology Group Myeloma IX Closed in follow up Randomised Oncology Group PT1 Closed in follow up Randomised Oncology Group RIAltO Open Randomised Oncology Group SPIRIT 2 Closed in follow up Randomised Oncology Group TEAMM: Tackling early morbidity and mortality in myeloma Open Randomised Head and Neck Cancer Group HOPON Open Randomised Head and Neck Cancer Group PET NECK study Closed in follow up Randomised Lung Cancer Group BTOG 2 Closed in follow up Randomised Lung Cancer Group LungStar Closed in follow up Randomised Lung Cancer Group MALCS (Mesothelioma and Lung Cancer Study) Open Nonrandomised Lymphoma Group RATHL Closed in follow up Randomised Lymphoma Group REMoDLB Open Randomised Upper Gastro Intestinal Cancer Group NCRN104 BIBF 1120 vs sorafenib in Adv HCC Open Randomised

60 Primary CSG Upper Gastro Intestinal Cancer Group Upper Gastro Intestinal Cancer Group Number of patients on Follow Up 2012/13 Study Acronym / Short Title Active Status Randomisation Type of follow Up GSTFT KCHFT LHT SLHT (PRUH Site) SLHT (QEW Site) Network Total NCRN256 Axitinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma therapy Closed in follow up Randomised NCRN301 ADI PEG 20 + BSC vs Placebo + BSC in 2nd line advanced HCC Open Randomised Upper Gastro Intestinal Cancer Group TACE 2 Open Randomised Total Please note the following: 1.This report only contains follow up information from the Breast (Oncology and Surgery), Gynaecology and Head & Neck Tumour Groups at GSTFT. 2.This report only contains follow up information from the Liver and Breast and Haematology (for some studies) Tumour Groups. Follow Up Categories: Type 1: Study data are collected by any member of staff designated in the study responsibility log. Study data collection includes clinical investigations which are: 1. Specified in the study protocol 2. Will be used to assess the patient s condition The results of which may be acted upon as required (i.e. the patient s care modified) Type 2: Study data are 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 1 follow up. Type 3: As for type 2 but the study data are not collected by study site personnel. 60

61 Appendix 4: SELCRN Summary of Activity Sheet 2001/2 to 2012/13 Year Incidence Number Patients RCT Non RCT Other recruits Percentage of Percentage of cancer cancer incidence Number incidence RCT Non RCT Total participants

62 Appendix 5: SELCRN Staff Listing Title of post Role WTE Hospital Site supported Funding Source WTE time spent on NIHR studies Clinical Research Lead Management team 0.2 All Network sites NCRN 0.2 Research Network Manager Management team 1 All Network sites NCRN 1 Lead Research Nurse Management team 1 All Network sites NCRN 1 Clinical Trials Manager Management team 1 GSTFT GSTFT 0.5 Lead Research Nurse Management team 0.6 GSTFT GSTFT 0.5 Clinical Trial Manager Management team 0.6 KCHFT KCHFT 0.3 Clinical Trial Manager Management team 1 KCHFT KCHFT 0.2 Set Up Specialist Management team 1 GSTFT GSTFT 0 Quality Manager Management team 1 GSTFT GSTFT 0.5 Clinical Trials Project Facilitator Administrator 1 All Network sites NCRN 1 Clinical Trials Coordinator Administrator 1 All Network sites NCRN 1 Clinical Trials Coordinator Administrator 1 All Network sites CLRN 1 Research Nurse Research Nurse 11.2 GSTFT GSTFT 2.5 Research Nurse Research Nurse 3 GSTFT CLRN 3 Research Nurse Research Nurse 1 LHT NCRN 1 Research Nurse Research Nurse 3 SLHT CLRN 3 Research Nurse Research Nurse 3 KCHFT CLRN 3 Research Nurse Research Nurse 1 SLHT NCRN 1 Research Nurse Research Nurse 2 SLHT RCF 2 Research Nurse Research Nurse 1 KCHFT RCF 1 Research Nurse Research Nurse 0.5 KCHFT CLRN 0.5 Research Nurse Research Nurse 0.5 SLHT CLRN 0.5 Research Nurse Research Nurse 1 KCHFT CLRN 1 Research Nurse Research Nurse 1 SLHT CLRN 1 Research Nurse Research Nurse 1 KCHFT NCRN 1 Comments 62

63 Title of post Role WTE Hospital Site supported Funding Source WTE time spent on NIHR studies Research Nurse Research Nurse 1 LHT CLRN 1 Research Nurse Research Nurse 1 KCHFT RCF 1 Clinical Trials Coordinator Research Nurse 4 KCHFT KCHFT 2 Clinical Trials Coordinator Research Nurse 0.8 KCHFT NHSBT 0.8 Clinical Trials Coordinator Research Nurse 1 KCHFT LLR 1 Clinical Trials Coordinator Research Nurse 1 KCHFT KCHFT 0 Clinical Trials Practitioner / Clinical Trials Coordinator Officer 1 KCHFT MUK 1 Clinical Trials Practitioner / 60% CLRN 40% Clinical Trials Coordinator Officer 1 KCHFT LLR 1 Clinical Trial Co ordinator Clinical Trials 2 Practitioner/Officer GSTFT CLRN 2 Clinical Trial Co ordinator Clinical Trials 1 Practitioner/Officer GSTFT ECMC 1 Clinical Trial Co ordinator Clinical Trials 18 Practitioner/Officer GSTFT GSTFT 6 Clinical Trial Co ordinator Clinical Trials 3 Practitioner/Officer GSTFT KCL 1.5 Clinical Trials Officer Clinical Trials 1 Practitioner/Officer KCHFT NCRN 1 Clinical Trials Officer Clinical Trials 2 Practitioner/Officer SLHT RCF 2 Clinical Trials Officer Clinical Trials 2 Practitioner/Officer SLHT NCRN 2 Clinical Trials Officer Clinical Trials 1 Practitioner/Officer LHT NCRN 1 Clinical Trials Practitioner / Clinical Trials Coordinator Officer 1 KCHFT CLRN 1 SELCRN Research Pharmacist Service support (pharmacy, 0.4 radiotherapy etc) All Network Sites Other 0.4 Comments 63

64 Hospital Site supported WTE time spent on NIHR studies Title of post Role WTE Funding Source Clinical Trials Pharmacist Service support (pharmacy, 0.5 radiotherapy etc) GSTFT GSTFT 0 Clinical Trials Pharmacist Service support (pharmacy, 0.6 radiotherapy etc) GSTFT GSTFT/CLRN 1 Imaging & Histopath Co ordinator Service support (pharmacy, 1 radiotherapy etc) GSTFT GSTFT/CLRN 0.5 Pharmacy Technician Service support (pharmacy, 1 radiotherapy etc) GSTFT CLRN 1 Research Sonographer Service support (pharmacy, 0.4 radiotherapy etc) GSTFT GSTFT 0.2 Trial Pharmacy Technician Service support (pharmacy, 1 radiotherapy etc) GSTFT GSTFT 0.4 Clinical Trials Administrator Data Manager 0.4 LHT Other 0.4 Clinical Trials Administrator Data Manager 2 SLHT Other 2 Data Coordinator Data Manager 1 KCHFT 0.5 CLRN 0.6 Data Coordinator Data Manager 1 KCHFT KCHFT 0.5 Data Coordinator Data Manager 1 KCHFT KCHFT Comments 64

65 Appendix 6 List of Chief Investigators in the Network No Name of Chief Investigator Clinical Studies Group (CSG) Name of Clinical Trial/Study 1 Dr Danielle Harari All Clinical Studies Group Geriatric Oncology Liaison Pilot Intervention 2 Professor Paul Ellis Breast Cancer Group NCRN Professor Andrew Tutt Breast Cancer Group TNT 4 Professor Andrew Tutt Breast Cancer Group Genome Profiling in ER Negative Breast Cancer 5 Mr Michael Douek Breast Cancer Group Sentimag Multicentre Study 6 Mr Anand Purushotham Breast Cancer Group TPI in vivo study in breast cancer and sentinel lymph nodes 7 Professor Emma Ream Breast Cancer Group Barriers to Early Presentation and Diagnosis 8 Miss Eunice Jeffs Breast Cancer Group Patient perception of success and benefit in self care BCRL treatment 9 Ms Christine Jacobs Breast Cancer Group Communication About Hereditary Cancer 10 Professor Vicky Goh Colorectal Cancer Group PROSPECT 11 Professor Amanda Ramirez Gynaecological Cancer Group Symptoms of Cervical Cancer in Young Women 12 Professor Claire Harrison Oncology Group NCRN Professor Claire Harrison Oncology Group NCRN Professor Claire Harrison Oncology Group NCRN Professor Claire Harrison Oncology Group MAJIC 16 Professor Stephen Devereux Oncology Group CLEAR 17 Professor Ghulam Mufti Oncology Group DEC MDS 18 Professor Judith Marsh Oncology Group HLA Epitope Matched Platelet Transfusion Study 19 Dr Majid Kazmi Oncology Group NCRN Professor Stephen Schey Oncology Group NCRN Professor Stephen Schey Oncology Group NCRN Prof Stephen Schey Oncology Group MUK One 23 Dr Teresa Guerrero Urbano Head & Neck Cancer Group BOHEMIAN 24 Dr Rohit Lal Lung Cancer Group NCRN Dr David Landau Lung Cancer Group IDEAL CRT 26 Dr Robert Marcus Lymphoma Group NCRN

66 No Name of Chief Investigator Clinical Studies Group (CSG) Name of Clinical Trial/Study 27 Dr Teresa Beynon Lymphoma Group Developing a model of best practice for Cutaneous T cell lymphoma 28 Professor Sean Whittaker Lymphoma Group NCRN Professor Sean Whittaker Lymphoma Group EORTC Dr George Mikhaeel Lymphoma Group Blinded evaluation of prognostic value of FDG PET after 2 cycles of chemotherapy in Diffuse Large B cell Non Hodgkin s Lymphoma 31 Dr Mark Harries Melanoma Group NCRN Professor John Moxham Palliative & Supportive Care Group Development of KCH breathlessness service 33 Dr Matthew Maddocks Palliative & Supportive Care Group NMES in Severe COPD 34 Professor Irene Higginson Palliative & Supportive Care Group The IARE Study 35 Professor Myra Hunter Prostate Cancer Group Managing hot flushes and night sweats following prostate cancer 36 Dr Simon Chowdhury Prostate Cancer Group NCRN Mr Rick Popert Prostate Cancer Group Histoscanning for detection and localisation of prostate cancer 38 Professor Hardev Pandha Prostate Cancer Group Impact of Zoledronic acid and IL2 on gamma delta T cells 39 Professor Irene Higginson Psychosocial Oncology Group Quality of life in multiple myeloma and follicular lymphoma 40 Dr David Landau Radiotherapy Group FLT PET to assess tumour proliferation during radical radiotherapy 41 Mr Tim O'Brien Renal Cancer Group Salivary Markers for Renal Cancer 42 Dr Paul Ross Upper Gastro Intestinal Cancer Group NCRN

67 Appendix 7 Executive Summary of Pan London and SE England Regional Training and Education Group Annual Report Executive Summary Key achievements and challenges of the Region during The Pan London & South East Workforce Development Regional Group 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 NCRN-led 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 NRCN/CLRN Training & Development Collaborative Course. This was and 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 Group and South East CLRN training cluster. Several members of the Regional Group are Module Champions namely: Helen Graham, Carrie Weller, Nicola Southwell with Gillian Ellis acting as the overall Programme Coach. The Regional Group 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 Group throughout the year namely, Linda Dawson-Athey, Sandra Burt, Helen Graham and Anne Haldeos. Finally, Susan Palmer s efforts to manage the recruitment and appointment of a new Regional Workforce Development Lead in July-September 2012 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 The key priorities for are: To plan a programme of courses within the budget available and to manage the payment and reconciliation and reporting of expenditure. To implement and manage the core cancer, communication and other course programmes. To design, develop and pilot a Team Leader Training Course. To design, develop and pilot an Informed Consent & Pharmacovigilance. Workshop. To manage the changes in workforce development that will come with the organisational re-structuring from April 2014 to ensure a smooth transition and continuity in workforce development provision. 67