Dr Stephen Falk Clinical Director CRN West of England Clinical Research Network West of England SWAG SSG Colorectal Meeting Wednesday 30th November 2016 Dr Stephen Falk Clinical Director CRN West of England

Clinical Research Network & Cancer Services West ofEngland SWAG - Somerset Wiltshire Avon & Gloucestershire

NIHR CRN High Level Objectives Increase number of participants into NIHR CRN portfolio studies 650,000 in England 21,905 in West of England Increase the number of studies that deliver to time and target Target 80% Increase number of commercial studies delivered through network 650 new studies this year 75% of all commercial studies Reduce NHS study set up times Reduce time taken to recruit first participant

NIHR CRN Objectives for cancer Recruit 20% of cancer incidence West of England 1,909 Recruit 7.5% of cancer incidence into interventional studies 716 Include challenging studies Cancer surgery – 4 recruits per 100,000 population Radiotherapy – 6 recruits per 100,000 population Rare cancers (<6 per 100,000) – 12 recruits per 100,000 population Children & young people – 3 per 100,000 population Teenagers & young adults – record number of 16-25 year olds participating in research

Why do research ? Adjusted survival curves for patients treated in institutions with high research participation. Adjusted survival curves for patients treated in institutions with high research participation. It shows the cumulative survival for patients treated in institutions that have ≥16% participation in interventional clinical trials for 0, 3 or ≥4 years. At the scale of this graph the results for 1 and 2 years are superimposable over that for 0 years. The curves are highly significantly different and show that the separation occurs principally in the first year of follow-up. Survival is adjusted for primary procedure, index admission, Dukes’ stage, age, deprivation and Experimental Cancer Medicine Centre status. Amy Downing et al. Gut doi:10.1136/gutjnl-2015-311308 Copyright © BMJ Publishing Group Ltd & British Society of Gastroenterology. All rights reserved.

UK landscape Political commitment to supporting life-sciences industry Health & Social Care Act 2012 / NHS Constitution 2013 Embed clinical research in all aspects of care https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/32457/11-1429-strategy-for-uk-life-sciences.pdf (2011) The vision for life sciences in the UK- The UK will become the global hub for life sciences in the future, providing an unrivalled ecosystem that brings together business, researchers, clinicians and patients to translate discovery into clinical use for medical innovation within the NHS. The UK will provide an environment and infrastructure that supports pioneering researchers and clinicians to bring innovation to market earlier and more easily, making the UK the location of choice for investment. Life Sciences will continue to be vibrant in the UK and will be a key contributor to sustained economic growth. (2011) NHS response to the strategy- accelerate adoption into the NHS. For our health and wealth. Clinical Research Network

UK v Europe 2016 Data source: http://clinicaltrials.gov/ 1. Germany 2. United Kingdom 3. France 4. Spain 5. Italy If they are considering where in Europe to place their trial – this information might be useful/surprising Data source: http://clinicaltrials.gov “All studies received from 01/04/2014 to 31/03/2015 – last financial year” (All Phase II, III, IV studies received from 01/04/2015 to 31/03/2016 funded by Industry) Retrieved online on 07/09/2016 Clinical Research Network

The evidence: increased volume Number of new commercial studies added to the NIHR CRN Portfolio This is our own data - Confidence in quality There are other ways of looking at our data but all show steady increase for commercial contract research. Slide shows number of NEW studies – number of studies added to our Portfolio to which we pledged delivery support – this also captures support that we provide in ‘set-up’ before a study begins actively recruiting. Annual performance commentary The number of commercial contract studies entered onto the NIHR CRN Portfolio in 2014/15 is at an all time high, with a 17% increase compared to 2013/14 This percentage annual increase has been consistently delivered for the last five years, with twice as many new studies supported this year compared to 2010/11 (623 compared to 324) Improvements in delivery of commercial contract research, supported by the NIHR CRN, has led to increased repeat business with newer customers

The evidence: recruitment Number of participants into commercial NIHR CRN Portfolio studies 146,664 patients recruited to industry studies over the last 6 years 34,339 patients recruited to commercial contract studies in 15/16 16 first global patients in 2015/16 13 first European patients in 2015/16

% Recruitment of cancer incidence to interventional studies by Local Clinical Research Network 2016-17

Open studies in SWAG – Colorectal Cancer Portfolio ID Project Title Site Principal Investigator BRAG Rating Recruit- ment Site Target Planned End Date 1269 NSCCG Gloucestershire Hospitals Benstead, Dr Kim -34.77% 154 300 30/09/2018 Great Western Hospitals Blesing, Dr Claire 779.36% 130 15 North Bristol NHS Trust Lyons, Ms Ann 487.93% 211 37 Royal United Hospitals Bath Milsom, Mrs Carey 138.51% 226 100 University Hospitals Bristol Falk, Dr Stephen J 10.88% 253 258 Weston Area Health NHS Trust Muldoon, Annie 4212.60% 215 5 BRAG Open studies Black Study not reported recruitment or study has not recruited Red % Recruitment is more than 30 behind % time elapsed, i.e. Difference < -30 Amber % Recruitment is less than 30 behind % elapsed time but more than 0 behind % elapsed time, i.e. -30 < Difference < 0 Green % Recruitment is equal to or greater than % elapsed time, i.e. Difference >= 0 Grey Unable to calculate RAG due to record missing at least one data point All open studies at present are non-commercial

Open studies in SWAG – Colorectal Cancer Portfolio ID Project Title Site Principal Investigator BRAG Rating Recruitment Site Target Planned End Date 1269 NSCCG Taunton and Somerset FT Beaumont, Erica 38 131 120 30/09/2018 Yeovil District Hospital Sephton, Dr Matthew 58 94 20 3771 FOxTROT Great Western Hospitals Lowndes, Dr Sarah -35.01% 6 31/03/2018 North Bristol NHS Trust Lyons, Ms Ann 12.47% 15 12 Royal United Hospitals Bath De Winton, Dr Emma 127.77% 16 8 University Hospitals Bristol Thomas, Michael G -57.65% 30 40 Weston Area Health NHS Trust Hilman, Dr Serena -160.10% 2 5 Barlow, Dr Clare 9 -3 3

Open studies in SWAG – Colorectal Cancer Portfolio ID Project Title Site Principal Investigator BRAG Rating Recruitment Site Target Planned End Date 7590 CORGI University Hospitals Bristol Donaldson, Dr Alan -29.40% 19 100 31/05/2026 7890 Aristotle Gloucestershire Hospitals Benstead, Dr Kim -90.50% 8 60 21/09/2016 Great Western Hospitals Blesing, Dr Claire -53.90% 3 10 21/09/2017 Falk, Dr Stephen J -32.99% 38 75 31/10/2017 Taunton and Somerset FT Beaumont, Dr Erica 16 2 Yeovil District Hospital 31 1 8078 MERCURY 2 Weston Area Health NHS Trust Pye, Mr Geoff -148.55% 5 30/09/2015 8882 Raman colon diagnostics Kendall, Dr Catherine -18.28% 42 50 30/09/2016

Open studies in SWAG – Colorectal Cancer Portfolio ID Project Title Site Principal Investigator BRAG Rating Recruitment Site Target Planned End Date 9018 Pulmonary Metastasectomy in Colorectal Cancer (PulMICC) University Hospitals Bristol Batchelor, Tim 302.74% 76 21 30/04/2020 9340 Predisposition to serrated neoplasia and tumours (PRESENT) study Tomlinson, Prof Ian -91.98% 12 31/05/2017 14777 Hughes Abdominal Repair Trial (HART) Royal United Hospitals Bath Williamson, Mr Mike -3.36% 17 50 30/03/2018 Weston Area Health NHS Trust West, Mr Reuben -39.29% 3 10 31/03/2017 Yeovil District Hospital Francis, Mr Nader -17 9 15 15958 InterAACT - A Multicentre Randomised Phase II Advanced Anal Cancer Trial Great Western Hospitals Lowndes, Dr Sarah -94.77% 4 31/12/2016 University Hospitals Bristol Falk, Dr Stephen -12.01% 6 30/06/2017

Open studies in SWAG – Colorectal Cancer Portfolio ID Project Title Site Principal Investigator BRAG Rating Recruitment Site Target Planned End Date 14893 FOCUS 4 Gloucestershire Hospitals Benstead, Dr Kim 46.99% 10 8 01/01/2019 Great Western Hospitals Lowndes, Dr Sarah -40.40% 12 Royal United Hospitals Bath De Winton, Dr Emma 182.05% 18 University Hospitals Bristol Falk, Dr Stephen J -15.41% 30 60 Weston Area Health NHS Trust Hilman, Dr Serena 60% 9 Taunton and Somerset FT Barlow, Dr Clare -11 4 Yeovil District Hospital Sephton, Dr Matthew 109 6 5

Open studies in SWAG – Colorectal Cancer Portfolio ID Project Title Site Principal Investigator BRAG Rating Recruitment Site Target Planned End Date 16024 Does aspirin increase the clinical response to chemoradiotherapy? North Bristol NHS Trust McCarthy, Ms Kathryn -87.73% 1 30 31/01/2017 Royal United Hospitals Bath Cox, Dr Richard Ashley 308.32% 20 5 University Hospitals Bristol Thomas, Michael -63.18% 19 60 17006 IMPRESS Taunton and Somerset FT Beaumont, Erica -11 31/08/2019 Yeovil District Hospital Beaumont, Dr Erica -24 30901 3D vs 2D laparoscopic rectal surgery Francis, Mr Nader 18 2 8 31/12/2017

Studies in set up –Colorectal Cancer Portfolio ID Study Title Project Type Site PI 20576 TRIGGER - Magnetic Resonance Tumour Regression Grade (mrTRG) As A Novel Biomarker To Stratify The Management Of Good And Poor Responders To Chemoradiotherapy: A Rectal Cancer Multicentre Randomised Control Trial Non-Commercial Interventional University Hospitals Bristol   31184 PLATO - PersonaLising Anal cancer radioTherapy dOse Falk, Dr Stephen 31203 STAR-TReC - Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer?

Useful links https://www.crn.nihr.ac.uk/ National and local network information including training programmes templates, tools, contacts, videos etc https://odp.nihr.ac.uk/ http:/ Open data platform. Look at performance across whole CRN including all specialty areas /csg.ncri.org.uk/portfolio/portfolio-maps/ View current national portfolio of open, closed and ‘in set up’ cancer studies https://www.ukctg.nihr.ac.uk/ See where a study is open across the country http://public-odp.nihr.ac.uk/  Search for a study to fit criteria. Good for horizon scanning, eligibility criteria

Contacts Research Delivery Manager – maxine.taylor@nihr.ac.uk Cancer portfolio facilitator – sarah.west@nihr.ac.uk