1. Are we developing the next generation of clinical trialists? Peter Sandercock University of Edinburgh ICTMC Glasgow 17 th November 2015

2. My impression of ICTMC 2015 Lots of energetic and youthful folks We can make trials more efficient Need SWATS to improve trial methods Value of patient and public involvement Qualitative research adds value to RCTs Evidence synthesis essential part of RCT

3. Were there any gaps? Not many clinicians present, little on developing the next generation of clinical trialists

4. Thanks for the opportunity to stand on a soap box and raise these issues

5. What does a ‘clinical trialist’ look like? Search Google Images for ‘clinical trialist’ and this is what you get: James Lind But this is what clinical trialists look like now: part of a team

6. What REALLY matters in making trials happen - the people The trial team –Chief Investigator –Trial Management Group (TMG) –Trials Unit supporting the TMG Steering Committee Data Monitoring Committee …are we investing enough in these important human resources?

7. My ‘training’ as a clinician CI This training route no longer exists! Trained in Stoke, Manchester, Oxford Observed variation in treatment of MI; uncertainty – which expert was ‘correct’? As a clinical trainee, helped recruit patients into UK-TIA aspirin study (CI C. Warlow) – Introduction to practicalities of trials – Educational – Understanding clinical uncertainty

8. Charles Warlow PS

9. What next? Had to do research (MD) to increase chances of a consultant job, but I’m hopeless at lab work Got 2 year research post on community-based stroke incidence study in Oxford Formal training: 5 day course in Epidemiology Funded 3 rd year of MD by working on a systematic review of aspirin trials in prevention stroke / MI with Richard Peto Completed clinical training Consultant post funded by Charles Warlow’s MRC programme grant

10. Clinical question: why the variation in angiography in UK-TIA aspirin study? UK TIA study group BMJ 1983

11. Uncertainty -> ECST European Carotid Surgery Trial (ECST), led by Charles Warlow, in collaboration with CTSU, Oxford 3024 Patients with recent minor stroke or TIA Narrowing of relevant carotid artery Randomised to – immediate surgery + best medical treatment vs – best medical treatment Results 1998: Surgery beneficial for severe narrowing, harmful for minor narrowing Huge impact on practice

12. Fast forward to 2015 Huge progress Increase in number of trials, CTUs NIHR funding – a wide range of RCTs – trials networks: UKCRN Trials methodology – MRC network / Hubs for trials methodology – 3 rd Trials Methodology conference – EQUATOR network BUT – Many trials still too small, don’t provide clear answers – Difficulties developing the trial leaders of the future

13. Difficulties of becoming a CI Clinical trials need leadership, someone to lead the team, and to ‘shoulder the responsibility’ Motivation to become a CI often arises from questions arising in everyday clinical practice Training in methodology important, but so is ‘Learning by doing’ For clinicians: Developing a trial does not fit 3-5 year clinical training programmes or research training fellowships For non-clinical CI: many fewer research career development opportunities than for medics.

14. Where are the DMC members? DMC’s play a key role in clinical trials 1 The responsibilities placed on DMCs are changing and increasing 2 The trials environment is changing There appears to be shortage of suitably qualified people to serve on DMCs 2 Experienced enough to ‘Keep their nerve’ 1 The work of being on a DMC is not well recognised by current ‘academic metrics’ 2 1. Claire Snowdon, BRACELET, ICTMC 2015. 2. Rob Califf JAMA 2013

15. And careers for trial management team members?

17. Problems for trial team members Within large CTU’s, career progression is possible For trial teams outside CTUs, many key staff not on core funding, on contracts only for the duration of the trial Which creates problems: – Job security (paying the mortgage) – Training – Career progression – And risks the loss of their valuable expertise at trial end

18. Progress NIHR – Research Methods Fellowships (an MSc plus a year of project work) – NIHR CTU Fellowships- 6 month extensions to NIHR fellowships give time attached to a CTU. Methodology hub courses –How to be a good CI –How to serve on a DMC + short on-line training Informal DMC ‘observerships’ Training in Trials –Courses in Trial Design, Trial Management –MScs in Clinical Trials (LSHTM, Edinburgh) –Clinical Trial ‘Clerkships’ @ BCTU and elsewhere Surgical Trials collaborative run by surgical trainees Trials Managers Network –> 850 members, annual meeting –No core NIHR funding

19. Wish list An academic training programme for would-be clinician CI’s (current schemes favour basic science) A better career pathway for non- clinical CI’s More people willing to shoulder the burden of senior clinical trials work (CI, DMC etc)

20. Targets for ICTMC 2017? Stronger evidence base on efficient trial conduct – on the way Stronger training programmes for CI (clinical/non-clinical) – we hope Greater capacity to support demand for (wise) TSC DMC members prepared to ‘shoulder the burden’ / reward & recognise them – we hope Greater career stability/development for trial team members /TMRN – please!

21. Thank you and have a safe journey home