Are we developing the next generation of clinical trialists?

Peter Sandercock

University of Edinburgh

ICTMC Glasgow17th November 2015

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

Were there any gaps?

Not many clinicians present, little ondeveloping the next generation of clinical trialists

Thanks for the opportunity to stand on a soap box and raise

these issues

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

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?

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

Charles Warlow PS

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 3rd 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

Clinical question: why the variation in angiography in UK-TIA aspirin study?

UK TIA study group BMJ 1983

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

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– 3rd Trials Methodology conference – EQUATOR network

• BUT– Many trials still too small, don’t provide clear answers– Difficulties developing the trial leaders of the future

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.

Where are the DMC members?

• DMC’s play a key role in clinical trials1

• The responsibilities placed on DMCs are changing and increasing2

• The trials environment is changing• There appears to be shortage of suitably

qualified people to serve on DMCs2

• 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

And careers for trial management team members?

And careers for trial management team members?

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

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

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)

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!

Thank you and have a safe journey home