1. 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

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

3. 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

4. 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 year olds participating in research

5. 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: /gutjnl
Copyright © BMJ Publishing Group Ltd & British Society of Gastroenterology. All rights reserved.

7. 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
(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

8. 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:
“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

9. 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

10. 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

12. % Recruitment of cancer incidence to interventional studies by Local Clinical Research Network

15. 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 %
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

16. 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 % 2 5
Barlow, Dr Clare 9 -3 3

17. 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 % 5
30/09/2015
8882
Raman colon diagnostics
Kendall, Dr Catherine
-18.28% 42 50
30/09/2016

18. 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

19. 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

20. 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

21. 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?

23. Useful links https://www.crn.nihr.ac.uk/
National and local network information including training programmes templates, tools, contacts, videos etc
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
See where a study is open across the country
Search for a study to fit criteria. Good for horizon scanning, eligibility criteria

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