Moondance Programme Annual Project Report

Transcription

1 Moondance Programme Annual Project Report Project Name: R&D Clinical Lead Project Lead: Dr Mererid Evans Funding Approval Date: Project Term: 3 years Financial 63,000 Next Review Award: Date: Project Brief: 7 th July 2016 September 2017 The aim of the R&D Clinical Lead Post is to report to the Clinical Lead for the Moondance Programme and the Moondance Programme Board (MPB), ensuring that annual objectives are set for Moondance projects and reports against these objectives are delivered to the MPB (and be available for the CFC as required). A wider strategic role in radiotherapy research and in the future of Moondance is envisaged. Main Outputs Individual progress review meetings: Dr Evans has held individual progress review meetings held with project leads: Thomas Rackley (SABR) Paul Shaw (Novel Drug and RT) Ceri Powell (SWW Lung SABR Service) James Powel (NCF Study) Libby Crumpton (Programme PA) John Staffurth (PEARL) Geraint Lewis (STRT Development Physicist) As a result of discussions during meetings with Dr Rackley/Powell, the highly successful SABR Wales Conference was arranged in July 2017, attended by radiotherapy teams from VCC and ABMU which has the support of the Programme Clinical Lead to become an annual event Moondance project lead presentations: A meeting for all Moondance Project Leads was held in April 2017, Chaired by Dr Evans. The strategic aims and objectives of Moondance were presented by Dr Evans and the individual project leads presented their Moondance - funded work. The aim was to build collaborations and a common sense of purpose amongst Moondance funded groups. This will become an annual fixture at Dr Evans suggestion with the next all project lead meeting in May The next meeting of the Programme Board will take place on 25 th October Following a condensed Board meeting, a session will follow immediately afterward with each of the project leads giving high level presentations on their project progress. Invites to this meeting have been extended to the VNHST chief executive s office, senior management, R&D, finance and the Moondance Foundation.

2 Moondance Programme Annual Project Report Progress vs Milestones Dr Evans has attended R&D Committee meetings and presented a Programme highlight report, providing feedback to the Programme PA to ensure continued and improved communication with R&D. Although Dr Evans has led the introduction of a system of progress reporting for Moondance projects, she has been unable to take a wider, strategic role in the programme and its future direction due to time constraints (see below). Expenditure Securing backfill for Dr Evans time has proved problematic. Until September 2017, Dr Evans was not able to take up any sessional funding to support her Moondance role. From September 2017, she will take up 1 session/week for her Moondance role. Discussions with VCC management are ongoing to provide further support so she can take up 2 sessions/week to fulfil her role as intended.

3 Moondance Programme Annual Project Report Project Name: R&D Clinical Lead Project Lead: Dr Mererid Evans Funding Approval Date: Project Term: 3 years Financial 63,000 Next Review Award: Date: Project Brief: 7 th July 2016 September 2017 The aim of the R&D Clinical Lead Post is to report to the Clinical Lead for the Moondance Programme and the Moondance Programme Board (MPB), ensuring that annual objectives are set for Moondance projects and reports against these objectives are delivered to the MPB (and be available for the CFC as required). A wider strategic role in radiotherapy research and in the future of Moondance is envisaged. Main Outputs Individual progress review meetings: Dr Evans has held individual progress review meetings held with project leads: Thomas Rackley (SABR) Paul Shaw (Novel Drug and RT) Ceri Powell (SWW Lung SABR Service) James Powel (NCF Study) Libby Crumpton (Programme PA) John Staffurth (PEARL) Geraint Lewis (STRT Development Physicist) As a result of discussions during meetings with Dr Rackley/Powell, the highly successful SABR Wales Conference was arranged in July 2017, attended by radiotherapy teams from VCC and ABMU which has the support of the Programme Clinical Lead to become an annual event Moondance project lead presentations: A meeting for all Moondance Project Leads was held in April 2017, Chaired by Dr Evans. The strategic aims and objectives of Moondance were presented by Dr Evans and the individual project leads presented their Moondance - funded work. The aim was to build collaborations and a common sense of purpose amongst Moondance funded groups. This will become an annual fixture at Dr Evans suggestion with the next all project lead meeting in May The next meeting of the Programme Board will take place on 25 th October Following a condensed Board meeting, a session will follow immediately afterward with each of the project leads giving high level presentations on their project progress. Invites to this meeting have been extended to the VNHST chief executive s office, senior management, R&D, finance and the Moondance Foundation.

4 Moondance Programme Annual Project Report Progress vs Milestones Dr Evans has attended R&D Committee meetings and presented a Programme highlight report, providing feedback to the Programme PA to ensure continued and improved communication with R&D. Although Dr Evans has led the introduction of a system of progress reporting for Moondance projects, she has been unable to take a wider, strategic role in the programme and its future direction due to time constraints (see below). Expenditure Securing backfill for Dr Evans time has proved problematic. Until September 2017, Dr Evans was not able to take up any sessional funding to support her Moondance role. From September 2017, she will take up 1 session/week for her Moondance role. Discussions with VCC management are ongoing to provide further support so she can take up 2 sessions/week to fulfil her role as intended.

5 Moondance Programme Annual Project Report Project Name: Observational study of neurocognitive function in patients undergoing Stereotactic Radiosurgery Project Lead: Dr James Powell Funding Approval Date: Project Term: 2 years Financial Award: 126, Next Review Date: Project Brief: September 2016 Patient recruitment Feb 2017 TBC - July 2017 Radiotherapy treatment for brain metastases has traditionally involved treating the whole brain, called whole brain radiotherapy (WBRT). Technical developments now allow radiotherapy to be targeted precisely to small areas of cancer within the brain, called stereotactic radiosurgery (SRS) and combining WBRT and SRS improves survival compared with WBRT alone. WBRT has significant side effects particularly on short and long term memory and even with SRS alone, around half of patients suffer memory impairment. The mechanism for memory impairment is unknown but it is thought that certain areas of the brain, such as the hippocampus, are particularly sensitive to radiotherapy treatment. Structures within the body are considered to have tolerance levels of radiotherapy meaning that certain amounts of radiotherapy can be given to that part of the body before side effects occur. The radiotherapy tolerance doses for the hippocampus and other structures within the brain important for memory are not clear. Equally, the mechanism for how radiotherapy causes memory impairment is unknown but hypotheses exist for how radiotherapy may affect cerebral blood flow or cause physical changes in size or brain connectivity. In this study we will conduct detailed assessments of patient s memory before and at four time points after SRS treatment which will involve answering questionnaires, remembering lists and tasks involving the hands and we will perform MRI brain scans before treatment and at two time points after SRS. We will also calculate radiotherapy doses received by the brain structures important for memory in each patient and correlate memory changes with radiotherapy dose received by the structures and the structural or physiological changes seen on MRI scans. We predict that by correlating this information we will obtain important new insights into radiotherapy effects on memory and on the radiotherapy tolerance doses for these crucial structures when delivering SRS. Main Outputs Academic presentations (internal and external) Oral presentations (Internal and External) Neurocognition and Stereotactic Radiosurgery. Cardiff University Brain Research Imaging Centre (CUBRIC) NS Iqbal 28/ Neurocognition & Stereotactic Radiosurgery. Wales Cancer Research Centre Clinical Workshop. All Nations Centre, Cardiff. NS Iqbal 23/11/2016 Neurocognition & Stereotactic Radiosurgery. South Wales Radiotherapy Development Day J Powell. Bear Hotel, Cowbridge. 02/12/2016 Neurocognitive effects of Stereotactic Radiosurgery NS Iqbal, Presented at Brain Tumour Charity Day, Haydn Ellis Building, Cardiff University. 05/04/2017 MRI Protocol for the Study Presented to the Trial Steering Group NS Iqbal. CUBRIC, Cardiff 03/05/2017

6 Moondance Programme Annual Project Report Clinical Outcome and Hippocampus Dosimetry in patients treated with Stereotactic Radiosurgery NS Iqbal, UK Radiation Oncology Conference, Manchester 13/6/17 Development of a MRI protocol for an observational study of neurocognitive function in patients undergoing stereotactic radiosurgery M Smyth, All Wales Medical Physics and Clinical Engineering Meeting, Swansea. 16/06/2017 A retrospective review of Clinical Outcome and Hippocampus Dosimetry in patients treated with Stereotactic Radiosurgery NS Iqbal, British Neuro-Oncology Society Meeting, Edinburgh. 22/06/2017 An observational study of neurocognitive function in patients undergoing stereotactic radiosurgery at Velindre Cancer Centre J Powell, British Neuro-Oncology Society Meeting, Edinburgh. 22/06/2017 J Powell Presentation at Wales SABR Day, 7 th July 2017: Stereotactic Radiosurgery for Brain Metastasis. Publications Abstracts Hippocampus Dosimetry in patients treated with Stereotactic Radiosurgery for Brain Metastases across South Wales. Iqbal, NS., Powell, JR., Tilsley, DWO., Bryant, A., Millin, AE., Lewis, DG. and Staffurth, J. ESTRO May 2017 Accepted for poster presentation Clinical outcome and hippocampal dosimetry in patients treated with stereotactic radiosurgery for brain metastases across South Wales. Iqbal, NS., Powell, JR., Tilsley, DWO., Bryant, A., Millin, AE., Lewis, DG. and Staffurth, J. UKRO June 2017 Accepted for oral presentation An observational study of neurocognitive function in patients undergoing stereotactic radiosurgery at Velindre Cancer Centre. Powell JR., Iqbal NS., Smyth M, Johnson A, Smalley M, Wise R, Jones D. Tilsley DWO., Bryant A., Millin AE., Lewis DG. and Staffurth J. BNOS June 2017 Accepted for oral presentation A retrospective review of clinical outcome and hippocampus dosimetry in patients treated with Stereotactic Radiosurgery for Brain Metastases in South Wales. Iqbal, NS., Tilsley, DWO., Bryant, A., Millin, AE., Lewis, DG. and Staffurth, J., and Powell, JR. BNOS June 2017 Accepted for oral presentation Development of a MRI protocol for an observational study of neurocognitive function in patients undergoing stereotactic radiosurgery. Smyth, M., Iqbal, NS., Powell, J., Wise, R., Jones, D., Lewis, G., Staffurth, J. All Wales Medical Physics and Clinical Engineering Meeting June 2017 Accepted for Oral presentation Treatment planning of stereotactic radiosurgery (SRS) for patients with brain metastases: plan quality assessment of hippocampal avoidance. Davies, C., Williams, M., Iqbal, NS., Smyth, M., Chu, M., Bryant, A., Powell, J. and Millin, A. UK SABR Consortium November 2017 Accepted for poster presentation Trial activity: trials opened, patients recruited, trials designed Wales REC Approval Initial Approval 09/12/2016; Final Approval following amendments 09/03/2017 R&D Approval 31/01/2017 SLA between VCC and CUBRIC approved on 07/04/2017 Site Opened 10/04/2017 First patient recruited on 27/07/2017 Number of patients recruited: 6 New posts recruited Assistant Psychologist appointment start date 9/5/17

7 Moondance Programme Annual Project Report Collaboration Meeting with Prof Anthony Chalmers, Prof D Jones and Prof R Wise, CUBRIC, Cardiff. 05/04/2017 Progress vs Milestones There was a delay in gaining Ethics Committee Approval due to lack of staffing in radiation protection. This was overcome quickly. Service level agreement between Velindre Cancer Centre and Cardiff University was another challenge which was finally approved in April We have now opened the study and actively recruiting patients across South Wales. Expenditure Funding to date has been drawn largely for staffing costs including consultant sessions and clinical psychologist support. As of July 2017 patient MRI scans have commenced with at CUBRIC, with VCC and the Programme being charged as such. The cost of these scans, circa 75,000 across three years is the largest portion of project funding. Scans and subsequent invoices will continue as a steady pace throughout the course of the study.

8 Moondance Programme Annual Project Report Project Name: Early Phase Novel Drug-Radiotherapy Combinations Project Term: 3 years Financial Award: Project Brief: Project Lead: Dr Paul Shaw Funding Approval Date: 171,640 Next Review Date: 14 th October 2016 September 2017 Following the success of the Early Phase Trials unit at Velindre, there is a clear and attainable ambition to deliver Early Phase drug and radiotherapy combination trials, as an expansion of this work. The work of the Early Phase Unit has paved the way to deliver the next stage of intended activity. With the key components able to facilitate delivery, we wish to expand the current Velindre Clinical Trials Portfolio (managed by the Clinical Trials Unit (CTU)) by increasing early phase clinical trial activity that will support the combination of novel agent trials with radiation. This is a complex mix as radiotherapy is often already combined with systemic agents, at the edge of its tolerance in the curative setting, with the critical toxicity a late effect. Novel trial designs are often required, with recruitment from a relatively large number of centres. Main Outputs The first combined early phase drug and RT trial is now available in Wales and opened to recruitment at Velindre Cancer Centre In February Paradigm 2- OlaPArib and RADIotherapy or olaparib and radiotherapy plus temozolomide in newly-diagnosed Glioblastoma stratified by MGMT status: 2 parallel phase I studies There is one patient receiving treatment and 2 currently in screening with a band 6 Research Nurse now dedicated to these trials The following press releases were been issued along and circulated via the VCC and WCRC social media pages: Anthony Chalmers CI of the Paradigm trial visited Velindre in April to meet the team Both teams are working well together with monthly meetings to review progress and early phase attendance at the quarterly RT trial meeting to provide trial updates. There are 3 trials in the pipeline set to open this financial year- Orca, Plummb and Chariot with a portfolio of trials at EOI stage- one with a Velindre Oncologist to be Co-CI Copy of Prospective Aug 17.xlsx There has been communication with Swansea by the early phase clinical fellow attending MDT S to promote the phase 1 trials and All Wales Portfolio of RT trials collated via WCRC and circulated quarterly to ensure

9 Moondance Programme Annual Project Report access to these trials for patients beyond SE Wales There is ongoing engagement of VCC Oncologists and CU researcher s to look at and linking basic science with pre-clinical drivers and maximise outputs between Velindre and Cardiff University in the field of radiotherapy around imaging and biology/ drug-rt combinations Other engagement to includes talks at Clinical workshop at WCRC conference in October 2016 and Association of British Pharmaceutical Industry Conference June 2017 Drug/RT trial updates put on monthly consultant meeting agenda with update presentations to be given 6 monthly by RHJ/PS This project has been incorporated into the RT and early phase strategies PS has regular input as CoCI in future CONCORDE trial which will be the first national (possibly international) platform Phase I trial examining novel drug combos in Stage III (IV) NSCLC. We are hopefully going to be funded by AZ and CRUK. Progress vs Milestones No-one yet to take on PS clinical work so unable to give as much time as desires. A consultant position is due to be advertised in September to backfill PS sessions, possibly not in post until January Chariot was due to be the first trial to open- put on hold due to change in drug company, now set to open 2018 Hold up on the Data Manager post due to business case being held in R&D department during period of staff sickness Now at stage to go out for advert Expenditure

10 Moondance Programme Annual Project Report To date, including the month of September, 12, has been recharged to Moondance for the nursing post. This covers May to September 17/18. Position Name WTE Consultant Leadership Research Nurse - band 6 Paul Shaw 0.3 Jill Halpin Data Manager - band Dura tion 0.75 to 1 in year 3 3 Star t dat e Place ment Total Funding 3 year s TBC VCC 90,000 1st May VCC 92,383 3 year s TBC VCC 50,709 Comments Pending consultant sessions being adjusted. Rebecca Wilson started 1st May and is the backfill for Jill Halpin, who is already in post. Out to advert September 2017 role combined with another Moondance funded position to create 1 WTE.

11 VELINDRE NHS TRUST RESEARCH & DEVELOPMENT COMMITTEE REPORT Meeting Date: 6 th December 2017 Agenda Item: Report Author: Executive Sponsor: Presented by: Trust Research Performance Report Michael Morgan, Research Governance Officer Dr Jacinta Abraham, Trust Medical Director Sarah Townsend, Trust R&D Manager & Sponsor Representative RESEARCH & DEVELOPMENT ACTIVITY REPORT ACRONYMS R&D Research & Development SST Site Specific Team 1. PURPOSE & ACTION REQUIRED This report is presented to the R&D Committee to provide accurate data related to the Trust research performance, which is directly used to monitor Trust performance against Welsh Government Key Performance Indicators (KPIs). The R&D Committee are requested to review and note the current status of the Trust Research performance for information purposes. 2. INTRODUCTION It is the Trust R&D Office s responsibility to ensure that all Trust research performance data is accurate and valid. The R&D office works closely with the individual research and Health & Care Research Wales Information teams to interrogate and ensure that all Trust performance data is quality assured, and that the Trust s performance against R&D Division, Welsh Government Key Performance Indicators (KPIs) is correctly reported. This report summarises data captured centrally by the Site Specific Teams and Welsh Government and includes: The current status of the Trust national performance data for all applicable research study activity within the Trust within the time period captured on a cumulative basis. The Welsh Government Key Performance Indicators (KPIs) and the Trust

12 performance against them. 3. CONSIDERATION FOR THE COMMITTEE It should be noted on Page 10, 11, 12 & 13 that; C1. The Trust are on track to meet the Welsh Government target for the number of portfolio studies opening in Velindre NHS Trust. We have achieved 74% of our target (38/52) in quarter 2. D1. The Trust will potentially not meet the Welsh Government target for the number of patients recruited into portfolio studies. We have achieved 40% of our target (134/334) in quarter 2. C2. The Trust is on track to meet the Welsh Government target for the number of commercial studies opening in Velindre NHS Trust. We have achieved 66% of our target (9/14) in quarter 2. D2. The Trust is on track to meet the Welsh Government target for the number of patients recruited into commercial studies. We have achieved 44% of our target (22/50.) E1. The Trust are currently meeting the Welsh Government target for the number of portfolio studies receiving permission within 40 calendar days. We have achieved 100%. The target is 80%. E2. The Trust are currently meeting the Welsh Government target for the number of commercial studies receiving permission within 40 calendar days. We have achieved 100%. The target is 80%. E3. The Trust are on track to meet the Welsh Government KPI for the number of portfolio studies recruiting their first patient within 30 calendar days. We have currently achieved 75% of our target of 80%. E4. The Trust are meeting the Welsh Government KPI for the number of commercial studies recruiting their first patient within 30 calendar days. We currently have achieved 100%. The target is 80%. E5. The Trust are currently not meeting the Welsh Government KPI for the number of OPEN portfolio studies recruiting to time and target. We have currently achieved 43% of our target of 80%. E5. The Trust are currently not meeting the Welsh Government KPI for the number of CLOSED portfolio studies recruiting to time and target. We have currently achieved 33% of our target of 80%. E6. The Trust are currently not meeting the Welsh Government KPI for the number of OPEN commercial studies recruiting to time and target. We have currently achieved 31% of our target of 80%. E6. The Trust are currently not meeting the Welsh Government KPI for the number of CLOSED commercial studies recruiting to time and target. We have currently

13 achieved 0% of our target of 80%. E7. The Trust should meet the Welsh Government KPI for the number of nonrecruiting portfolio studies. 11% of our portfolio studies have not recruited a participant. The Welsh Government target is 10% E8. The Trust are currently not meeting the Welsh Government KPI for the number of non-recruiting commercial studies. 88% of our commercial studies have not recruited a participant. The Welsh Government target is 10% 4. ACTIONS/RECOMMENDATION TO THE COMMITTEE The R&D Committee should note the status of the current Trust Research Performance Report.

14 R&D Committee Performance Report Quarter 1 April - June

15 Velindre NHS Trust - Commercial & Non-Commercial Study Activity Overview Quarter 1 (April - June 2017) Data taken from the R&D Department Recruitment Database on the 11/9/ No of Studies April May June Open & Recruiting /17 for comparison - Open & Recruiting Open & Not Recruiting [Target < 12 per year] * /17 for comparison - Open & Not Recruiting [Target < 12 per year] * Open & Not Recruiting [Target 12 per year] /17 for comparison - Open & Not Recruiting [Target 12 per year] /17 for comparison - Total Active Studies Total Active Studies 2017/ * Please note: Studies with less than 12 recruits per year are not counted in the Welsh Government's recruitment to time and target KPI Q1 Recruitment April May June Recruitment /17 for comparison - Recruitment /17 for comparison - Running Total** Running Total** **Please note that where a section refers to a 'Running Total' this data is cumulative. 2

16 No of Studies April May June Closed to Recruitment and In Follow-up /17 for comparison - Closed to Recruitment and In Follow-up /17 for comparison - Running Total** Running Total** Please note: The above information covers the studies that have closed to recruitment and are in follow up for this period. These figures do not reflect all studies currently in follow up. No of New Studies April May June Approved /17 for comparison - Approved /17 for comparison - Running Total** Running Total** **Please note that where a section refers to a 'Running Total' this data is cumulative. 3

17 Studies Open to Recruitment in Quarter 1 (April - June 2017) by Trials Team Trials Team No. of Commercial Studies No. of Non-Commercial Studies Total No. of Studies Portfolio Non-Portfolio BLOOD BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG LYMPHOMA MULTI SITE * PALLIATIVE RADIOTHERAPY SKIN UPPER-GI UROLOGY Total * Please note: That 'Multi Site' refers to research studies that involve two or more disease sites/trials teams. 4

18 Commercial Non-Commercial Combined Total Interventional Non-Interventional Total Interventional Non-Interventional Total Non Portfolio Portfolio Total No. of Studies Open to Recruitment: Quarter 1 (April - June 2017) by Trials Team Commercial Portfolio Non-Commercial, Non-Portfolio * Please note: That 'Multi Site' refers to research studies that involve two or more disease sites/trials teams. 5

19 Velindre NHS Trust - Study Recruitment by Trials Team Quarter 1 (April - June 2017) Trials Team Total Open Studies Total Recruitment Commercial Non-Commercial No of Studies Recruitment No of Studies Recruitment BLOOD BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG LYMPHOMA MULTI SITE * PALLIATIVE RADIOTHERAPY SKIN UPPER-GI UROLOGY Total * Please note: That 'Multi Site' refers to research studies that involve two or more trials teams. 6

20 25 Study Recruitment Overview by Trials Team in Quarter 1 (April - June 2017) Non-Commercial Commercial * Please note: That 'Multi Site' refers to research studies that involve two or more trials teams. 7

21 Percentage of Recruitment in Quarter 1 (April - June 2017) by Trials Team 26% 3% 12% 5% 11% 2% 20% BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG RADIOTHERAPY UPPER-GI UROLOGY 6% 10% 5% 8

22 Studies Open to Recruitment by Trials Team in Quarter 1 (April - June 2017) Disease Site Total No of Commercial Non-Commercial Studies Recruiting Non-Recruiting Recruiting Non-Recruiting BLOOD BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG LYMPHOMA MULTI SITE * PALLIATIVE RADIOTHERAPY SKIN UPPER-GI UROLOGY Total * Please note: That 'Multi Site' refers to research studies that involve two or more trials teams. 9

23 100% Percentage of Recruiting/Non-Recruiting Studies in Quarter 1 (April - June 2017) R E C R U I T N G N O T - R E C R U I T I N G 80% 60% 40% 20% 0% -20% -40% -60% -80% -100% Non-Commercial Non-Recruiting Commercial Recruiting This graph shows the percentage of recruiting commercial/non-commercial studies against non-recruiting commercial/non-commercial studies. The top half of the graph shows the percentage of studies that have recruited in the time period stated and the lower half shows the studies that have not recruited. Around 80% of studies active within Velindre NHS Trust are expected to recruit less than 12 patients a year. On average these studies recruit between 2-4 patients a year and as such are likely to fall into the non-recruiting category each month. 10

24 Studies Closed to Recruitment and Currently in Follow-Up - Quarter 1 (April - June 2017) Trials Team Commercial Non-Commercial Portfolio Non-Portfolio Total BLOOD BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG LYMPHOMA MULTI SITE* PALLIATIVE RADIOTHERAPY SKIN UPPER-GI UROLOGY Total Please note: The above information covers the studies that have closed to recruitment and are in follow up for this period. These figures do not reflect all studies currently in follow up. * 'Multi Site' refers to research studies that involve two or more trials teams. 11

25 Commercial Studies Non-Commercial Studies Interventional Non-Interventional Total Interventional Non-Interventional Total Combined Total Non Portfolio Portfolio Total Studies that are Closed to Recruitment and are now in Follow-up - by Trials Team Quarter 1 (April - June 2017) Commercial Non-Commercial * 'Multi Site' refers to research studies that involve two or more trials teams. 12

26 Summary of Welsh Government Key Performance Indicators for 2017/18 Note: The Welsh Government have recorded 'N/A' where they do not have the available data from the Sponsor Data Source- Welsh Government NHS Research Performance Report Q1 (April - June 2017) C1 D1 Key Indicator 2016/17 comparison 2017/18 (Cumulative) Q1 Annual % change (TARGET: 10% Increase) 2017/18 Target (10% Increase) % of Target achieved No. Portfolio Studies 30-36% 52 58% /17 Data for comparison 27 No. patients recruited into Portfolio Studies /17 Data for comparison % % C2 D2 Key Indicator 2016/17 comparison 2017/18 (Cumulative) Q1 Annual % change (TARGET: 5% Increase) 2017/18 Target (5% Increase) % of Target achieved No. Commercially sponsored studies % 14 37% 2016/17 Data for comparison 8 No. patients recruited into commercially sponsored studies % 50 32% 2016/17 Data for comparison 25 13

27 E1 E2 Key Indicator % Portfolio Studies receiving NHS research permission within 40 calendar days* 2016/17 comparison 95% Q1 2017/18 Annual % (TARGET: 80%) 100% 100% 2016/17 Data for comparison 100% 95% % Commercially sponsored studies receiving permission within % 100% 100% calendar days* 2016/17 Data for comparison 100% 100% E3 % Portfolio Studies recruiting the first patient within 30 calendar days of approval/ site initiation^ 67% 67% 67% 2016/17 Data for comparison 100% 67% E4 % Commercially sponsored studies recruiting the first patient within 30 calendar days of approval/ site initiation^ 100% 2016/17 Data for comparison N/A 100% N/A N/A * Please note this target is the combined number of days taken to approve a study by Velindre NHS Trust and Health and Care Research Wales. ^ Please note this KPI only applies to studies with a planned recruitment rate of at least 1 patient per month. However, if recruitment has occurred within 30 days despite a target of less than 1 participant or patient per month, this will be included in the data and counted towards the KI. 14

28 E5 - Open Key Indicator 2016/17 comparison Q1 2017/18 Annual % (TARGET: 80%) % Open Portfolio Studies recruiting to time and to target 43% 46% 46% 2016/17 Data for comparison 48% 43% E5 - Closed % Closed Portfolio Studies that recruited to time and to target 22% 29% 29% 2016/17 Data for comparison 50% 22% E6 - Open % Open Commercially Sponsored Studies recruiting to time and to target 14% 33% 33% 2016/17 Data for comparison 30% 14% E6 - Closed % Closed Commercially Sponsored Studies that recruited to time and to target 33% 17% 17% 2016/17 Data for comparison 50% 33% 15

29 E7 Key Indicator 2016/17 comparison Q1 2017/18 Annual % (TARGET: 10%) % of non-recruiting Portfolio Studies within Velindre NHS Trust 28% 14% 14% 2016/17 Data for comparison 13% 28% E8 % of Non-recruiting Commercially Sponsored Studies within Velindre NHS Trust 33% 67% 67% 2016/17 Data for comparison 50% 33% 16

30 R&D Committee Performance Report Quarter 2 July September

31 Velindre NHS Trust - Commercial & Non-Commercial Study Activity Overview Quarter 2 (July - September 2017) Data taken from R&D Department Recruitment Database on the 21/11/ No of Studies April May June July August Sept Open & Recruiting /17 for comparison - Open & Recruiting Open & Not Recruiting [Target < 12 per year] * /17 for comparison - Open & Not Recruiting [Target < 12 per year] * Open & Not Recruiting [Target 12 per year] /17 for comparison - Open & Not Recruiting [Target 12 per year] Total Active Studies 2017/ /17 for comparison - Total Active Studies Q1 Q1 * Please note: Studies with less than 12 recruits per year are not counted in the Welsh Government's recruitment to time and target KPI Recruitment April May June July August Sept Recruitment /17 for comparison - Recruitment Running Total** /17 for comparison - Running Total** **Please note that where a section refers to a 'Running Total' this data is cumulative. Q1 Q1 2

32 No of Studies April May June July August Sept Closed to Recruitment and In Follow-up /17 for comparison - Closed to Recruitment and In Follow-up Running Total** /17 for comparison - Running Total** Q1 Q1 Please note: The above information details the studies that have closed to recruitment and are in follow up for this period. These figures do not reflect all studies currently in follow up **Please note that where a section refers to a 'Running Total' this data is cumulative No of New Studies April May June July August Sept Approved /17 for comparison - Approved Running Total** /17 for comparison - Running Total** **Please note that where a section refers to a 'Running Total' this data is cumulative. Q1 Q1 3

33 Studies Open to Recruitment in Quarter 2 (July - Sept 2017) by Trials Team Trials Team No. of Commercial Studies No. of Non-Commercial Studies Total No. of Studies Portfolio Non-Portfolio BLOOD BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG LYMPHOMA MULTI SITE * PALLIATIVE RADIOTHERAPY SKIN UPPER-GI UROLOGY Total * Please note: 'Multi Site' refers to research studies that involve two or more trials teams. 4

34 Commercial Non-Commercial Combined Total Interventional Non-Interventional Total Interventional Non-Interventional Total Non Portfolio Portfolio Total No. of Studies Open to Recruitment: Quarter 2 (July - Sept 2017) by Trials Team Commercial Portfolio Non-Commercial, Non-Portfolio * Please note: 'Multi Site' refers to research studies that involve two or more trials teams. 5

35 Velindre NHS Trust - Study Recruitment by Trials Team Quarter 2 (July - Sept 2017) Trials Team Total Open Studies Total Recruitment Commercial Non-Commercial No of Studies Recruitment No of Studies Recruitment BLOOD BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG LYMPHOMA MULTI SITE * PALLIATIVE RADIOTHERAPY SKIN UPPER-GI UROLOGY Total * Please note: 'Multi Site' refers to research studies that involve two or more trials teams 6

36 40 Study Recruitment Overview by Trials Team in Quarter 2 (July - Sept 2017) Non-Commercial Commercial * Please note: Multi Site' refers to research studies that involve two or more disease sites. 7

37 Percentage of Recruitment in Quarter 2 (July - Sept 2017) by Trials Team 7% 2% 1% 4% 29% 28% 6% BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG MULTI SITE * RADIOTHERAPY SKIN UPPER-GI UROLOGY 5% 4% 11% 2% 1% * Please note: 'Multi Site' refers to research studies that involve two or more disease sites. 8

38 Studies Open to Recruitment by Trials Team in Quarter 2 (July - Sept 2017) Disease Site Total No of Commercial Non-Commercial Studies Recruiting Non-Recruiting Recruiting Non-Recruiting BLOOD BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG LYMPHOMA MULTI SITE * PALLIATIVE RADIOTHERAPY SKIN UPPER-GI UROLOGY Total * Please note: 'Multi Site' refers to research studies that involve two or more trials teams. 9

39 100% Percentage of Recruiting/Non-Recruiting Studies in Quarter 2 (July - Sept 2017) R E C R U I T N G N O T - R E C R U I T I N G 80% 60% 40% 20% 0% -20% -40% -60% -80% -100% Commercial Non-Commercial This graph shows the percentage of recruiting commercial/non-commercial studies against non-recruiting commercial/non-commercial studies. The top half of the graph shows the percentage of studies that have recruited in the time period stated and the lower half show the studies that have not recruited. Around 80% of studies active within Velindre NHS Trust are expected to recruit less than 12 patients a year. On average these studies recruit between 2-4 patients a year and as such are likely to fall into the non-recruiting category each month. 10

40 Studies Closed to Recruitment and Currently in Follow-Up - Quarter 2 (July - Sept 2017) Trials Team Commercial Non-Commercial Portfolio Non-Portfolio Total BLOOD BRAIN BREAST COLORECTAL EARLY PHASE GYNAE H&N LUNG LYMPHOMA MULTI SITE* PALLIATIVE RADIOTHERAPY SKIN UPPER-GI UROLOGY Total Please note: The above information details the studies that have closed to recruitment and are in follow up for this period. These figures do not reflect all studies currently in follow up * 'Multi Site' refers to research studies that involve two or more trials teams 11

41 Commercial Studies Non-Commercial Studies Interventional Non-Interventional Total Interventional Non-Interventional Total Combined Total Non Portfolio Portfolio Total Studies that are Closed to Recruitment and are now in Follow-up - by Trials Team in Quarter 2 (July - Sept 2017) Commercial Non-Commercial

42 Summary of Welsh Government Key Performance Indicators for Quarter 2 (April - Sept 2017) Note: The Welsh Government have recorded 'N/A' when they do not have the available data from the Sponsor Data Source: Welsh Government NHS Research Performance Report Q2 (July September 2017) Key Indicator 2016/ /18 (Cumulative) Q1 Q2 Annual % change (TARGET: 10% Increase) 2017/18 Target (10% Increase) % of Target achieved C1 D1 No. Portfolio Studies % 52 74% /17 Data for comparison No. patients recruited into Portfolio Studies /17 Data for comparison % % C2 D2 Key Indicator 2016/ /18 (Cumulative) Q1 Q2 Annual % change (TARGET: 5% Increase) 2017/18 Target (5% Increase) % of Target achieved No. Commercially sponsored studies % 14 66% /17 Data for comparison 8 12 No. patients recruited into commercially sponsored studies % 50 44% 2016/17 Data for comparison

43 E1 Key Indicator 2016/17 % Portfolio Studies receiving NHS research permission within 40 calendar days* 95% Q1 2017/18 (Cumulative) Q2 Annual % (TARGET: 80%) 100% 100% 100% 2016/17 Data for comparison 100% 100% 95% E2 % Commercially sponsored studies receiving permission within 40 calendar days 100% 100% 100% 100% 2016/17 Data for comparison 100% 100% 100% E3 % Portfolio Studies recruiting the first patient within 30 calendar days of approval/ site initiation^ 67% 67% 100% 75% 2016/17 Data for comparison 100% 100% 67% E4 % Commercially sponsored studies recruiting the first patient within 30 calendar days of approval/ site initiation^ 100% 100% 100% 100% 2016/17 Data for comparison N/A N/A 100% 14

44 E5 - Open Key Indicator 2016/17 % Open Portfolio Studies recruiting to time and to target 43% Q1 2017/18 Annual % (TARGET: 80%) 45% 43% 43% 2016/17 Data for comparison 48% 46% 46% E5 - Closed % Closed Portfolio Studies that recruited to time and to target 22% 29% 50% 33% 2016/17 Data for comparison 50% 0% 22% E6 - Open % Open Commercially Sponsored Studies recruiting to time and to target 14% 33% 31% 31% 2016/17 Data for comparison 30% 25% 25% E6 - Closed % Closed Commercially Sponsored Studies that recruited to time and to target 33% 0% N/A 0% 2016/17 Data for comparison 50% 25% 33% 15

45 E7 Key Indicator 2016/17 % of non-recruiting Portfolio Studies within Velindre NHS Trust 28% Q1 2017/18 Annual % (TARGET: 10%) 14% 0% 11% 2016/17 Data for comparison 13% 33% 28% E8 % of Non-recruiting Commercially Sponsored Studies within Velindre NHS Trust 33% 88% N/A 88% 2016/17 Data for comparison 50% 25% 33% * Please note this target is the combined number of days taken to approve a portfolio study by Velindre NHS Trust and Health and Care Research Wales. ^ Please note this KPI only applies to studies with a planned recruitment rate of at least 1 patient per month. However, if recruitment has occurred within 30 days despite a target of less than 1 participant or patient per month, this will be included in the data and counted towards the KI. 16

46 Appendix 2 7 Velindre NHS Trust R&D Summary Report April - October 2017 Income Annual Plan Cummulative Totals Plan Actual Variance Corporate R&D Office (162,213) (94,624) (80,356) 14,269 Breast Academic Research Collaborative (75,409) (43,989) (51,520) (7,531) Clinical Trials Unit (949,578) (553,921) (527,580) 26,341 Clinical Trials Unit VCC Savings Plan (240,000) (140,000) (140,000) 0 Abiraterone Drugs for Trials (40,000) (23,333) (62,522) (39,189) Abiraterone Drugs for Trials - Savings Plan (40,000) (23,333) (23,333) 0 Phase 1 Unit (522,590) (304,844) (298,484) 6,360 Phase 1 Unit Overheads (120,000) (70,000) (70,000) 0 RT Trials Quality Assurance (RTTQA) (121,151) (70,671) (67,353) 3,318 Activity Based Funding (ABF) (896,201) (522,784) (522,784) 0 Total Income (3,167,142) (1,847,499) (1,843,932) 3,567 Expenditure Corporate R&D Office 300, , ,716 (24,432) Research Laboratories 301, , ,672 (22,192) Breast Academic Research Collaborative 75,409 43,989 51,710 7,721 Clinical Trials Unit 1,018, , ,970 (106,379) Clinical Trials Unit VCC Savings Plan , , ,000 0 Abiraterone Drugs for Trials 40,000 23,333 38,824 15,490 Phase 1 Unit 525, , ,171 (6,366) Phase 1 Unit Overheads 120,000 70,000 70,000 0 RT Trials Quality Assurance (RTTQA) 197, , ,928 (3,407) Embedded VCC Departmental Commitment (estimates) 656, , ,709 0 Total Expenditure 3,475,310 2,027,264 1,887,700 (139,564) Additional Support / Underspend 308, ,765 43,768 (135,997) 7.2 R&D Committee Finance Report - to Month Summary 1 of 3 19/03/ :58

47 Velindre NHS Trust Income and Expenditure Report April to October Plan ANALYSIS: Sources of Funding Income NHS Revenue Expenditure Velindre NHS Trust NHS Revenue Income Charitable Funds Trust Sponsored WCTU Studies NISCHR (Activity Based Funding) Research Support & Governance NHS Support Costs Researcher Support & Portfolio Development NISCHR CRC Staff Funding Cancer Research Wales NIHR Cardiff University OTHER Commercial Income Welsh Government Savings Other Corporate R&D Office (162,213) (143,412) (15,064) (3,737) Breast Academic Research Collaborative (75,409) (75,409) Clinical Trials Unit (949,578) (149,688) (80,132) (719,758) Clinical Trials Unit VCC Savings Plan (240,000) (240,000) Abiraterone Drugs for Trials (40,000) (40,000) Abiraterone Drugs for Trials - Savings (40,000) (40,000) Phase 1 Unit (522,590) (185,735) (146,102) (190,752) Phase 1 Unit Overheads (120,000) (120,000) RT Trials Quality Assurance (RTTQA) (121,151) (121,151) Activity Based Funding (ABF) (896,201) (210,000) (686,201) Total Income (3,167,142) (80,000) 0 (554,244) (15,064) (210,000) 0 (807,352) 0 (80,132) 0 (149,839) (1,030,510) 0 (240,000) 0 Expenditure Corporate R&D Office 300, , ,412 15,064 3,737 Research Laboratories 301, ,481 Breast Academic Research Collaborative 75,409 75,409 Clinical Trials Unit 1,141, , , ,882 Clinical Trials Unit - Staff Funding CRUK (122,882) (122,882) Clinical Trials Unit VCC Savings Plan 240, ,000 Abiraterone Drugs for Trials 40,000 40,000 Phase 1 Unit 525, , , ,102 Phase 1 Unit Overheads 120, ,000 RT Trials Quality Assurance (RTTQA) 197,718 76, ,151 Embedded VCC Departmental Commitment (estimates) 656, ,072 Total Expenditure 3,475,310 2,198, ,244 15, , , , , ,000 0 Additional Support / Underspend 308,168 2,118, (210,000) 0 (730,785) 0 (80,132) 121,151 0 (910,510) R&D Committee Finance Report - to Month Plan of 3 19/03/ :58

48 Velindre NHS Trust Income and Expenditure Report April to October 2017 Actual ANALYSIS: Sources of Funding Income NHS Revenue Expenditure Velindre NHS Trust NHS Revenue Income Charitable Funds Trust Sponsored WCTU Studies NISCHR (Activity Based Funding) Research Support & Governance NHS Support Costs NISCHR CRC Researcher Support & Staff Funding Portfolio Development Cancer Research Wales NIHR Cardiff University OTHER Commercial Income Welsh Government Savings Other Corporate R&D Office (80,356) (66,519) (8,787) (5,049) Breast Academic Research Collaborative (51,520) (51,520) Clinical Trials Unit (527,580) (89,186) (46,744) (391,650) Clinical Trials Unit VCC Savings Plan (140,000) (140,000) Abiraterone Drugs for Trials (62,522) (62,522) Abiraterone Drugs for Trials - Savings Plan (23,333) (23,333) Phase 1 Unit (298,484) (106,507) (81,509) (110,468) Phase 1 Unit Overheads (70,000) (70,000) RT Trials Quality Assurance (RTTQA) (67,353) (67,353) Activity Based Funding (ABF) (522,784) (122,500) (400,284) Total Income (1,843,932) (85,855) 0 (313,732) (8,787) (122,500) 0 (467,637) 0 (46,744) 0 (86,558) (572,119) 0 (140,000) 0 Expenditure Corporate R&D Office 150,716 70,360 66,519 8,787 5,049 Research Laboratories 153, ,672 Breast Academic Research Collaborative 51,710 51,710 Clinical Trials Unit 563, ,784 89,186 75,516 Clinical Trials Unit VCC Savings Plan 140, ,000 Clinical Trials Unit - Staff Funding CRUK (75,516) (75,516) Abiraterone Drugs for Trials 38,824 38,824 Phase 1 Unit 300, , ,507 81,509 Phase 1 Unit Overheads 70,000 70,000 RT Trials Quality Assurance (RTTQA) 111,928 67,353 44,575 Embedded VCC Departmental Commitment (estimates) 382, ,709 Total Expenditure 1,887,700 1,156, ,922 8, , ,575 86,558 70, ,000 0 Additional Support / Underspend 43,768 1,070, (122,500) 0 (400,284) 0 (46,744) 44,575 0 (502,119) 0 0 0

49 RESEARCH & DEVELOPMENT COMMITTEE FINANCE REPORT - MONTH 7 ( April to October 2017) Meeting Date: Author: Sponsoring Executive Director: Report Presented by: Tony Virgo, Deputy Director of Finance Nicola Hughes Assistant Finance Manager Mark Osland, Director of Finance Mark Osland, Director of Finance Committee/Group who have received or considered this paper: Trust Resolution to: (please tick) Approve: Endorse: Discuss: Note: Recommendation: The R&D Committee are asked to DISCUSS and NOTE the Finance Report for Months 1 to This report supports the following Trust objectives as set out in the Integrated Medium Term Plan: (please tick) Equitable and timely services Providing evidence based care and research which is clinically effective Supporting our staff to excel Safe and reliable services First class patient /donor experience Spending every pound well

50 2 [Report Title] 1. Introduction / Background: 1.1 This report is to update members of the Committee on:- 1) Financial performance against Plan and 2) Progress with R&D financial management 2. Timing: 2.1 The financial performance element analyses the income and expenditure plans for R&D activity within the Trust and shows Actual against the Plan for the period 1 st April 31 st October Description: 3.1 Financial Performance against Plan The Financial report shows the R&D income and expenditure for the 7 months to date, April - October 2017 as currently 136k underspent against Plan for The plan is heavily contingent on Commercial trials income and the expectation on delivering 959k of income in and includes 240k of divisional savings. A forecast is currently being worked through with the R&D manager and a more accurate figure will be known shortly. In k of Commercial trials income was generated. Currently the summary position reflects a nonachievement of 26k of income relating to commercial trials but this is more than offset with 106k of underspend on staff costs against Plan. The Plan included the full year cost of both a CTU Manager and a Finance and Contracts Manager whereas the position for the CTU Manager remains vacant and the R&D Finance and Contracts Manager was recruited after six months into the year and as such this saving will not be repeated through the next financial year 2017/18. There are still patients receiving the Abiraterone drug on trial and VCC are able to recharge the drug at a higher price than cost and effectively generate a profit. Patients were expected to tail off this trial towards the end of last financial year which was reflected in the lower values within the original Plan. The Phase 1 unit is expected to breakeven. Finance will work with the R&D Manager for a more accurate forecast position on commercial trials income and advise against progress in future reports. 3.2 Financial Management As previously advised the Finance department is currently under restructure but with the demands and expectations on Finance within the R&D department being of such high importance a R&D Finance and Contracts Manager has now been recruited on a six month contract A temporary Band 5 Finance Support has also been recruited via an agency. A handover of all R&D activities will be done over the coming month. 4. Financial Impact Summary R&D financial information is detailed in Appendix 1. The Finance and Contracting Manager post has been recruited to. Page 2