Matt SydesDay 3 #RedemptionWeek for #ClinicalTrials #Methodology papers focuses on oversight of #ClinicalTrials.
Robust clinical trial oversight is critical to the validity
and safety of trials. Clear oversight structures benefit trials.
1/12
Most academic-led trials in the #UK use a 3-committee approach:
A >> TMG
B >> IDMC/DSMB
C >> TSC
(Acronyms defined below)
...but that’s not the same the world over.
2/12
Quick definitions
A >> TMG = Trial Management Group – key people involved, day-to-day responsibility
3/12
Quick definitions //cont
B >> IDMC/DSMB = Independent Data Monitoring Committee / Data Safety Monitoring Board – only group to see accumulating (comparative) data from trial, usually independent
4/12
Quick definitions //cont
C >> TSC = Trial Steering Committee – some key people from TMG plus some other independent people
5/12
In today’s paper, we set out the rationale for that third committee, the Trial Steering Committee (TSC), with its mix of independent and non-independent members.
There are benefits and challenges to this approach and the paper covers a number of these issues.
6/12
The paper was published (open access ) in Clinical Trials https://doi.org/10.1177/17407745198816 with @janetalaneBris and @Carrol_Gamble leading.
It built on @mrcnihrtmrp projects on TSCs, mirroring work from DAMOCLES on IDMCs.
Other co-authors were @willjcragg and @deemtembo
7/12
That was early in 2020 when the world was getting a little distracted by Covid-19.
I wonder what oversight approaches were used by the plethora of Covid-19 trials.
8/12
We’ve run courses on TSC’s with NIHRr and will again in May with HRB TRMN in Ireland. You can book now at https://www.hrb-tmrn.ie/training-education/upcoming-events/
It complements the UCL short course on Data Monitoring Committees https://www.ucl.ac.uk/clinical-trials-and-methodology/education/short-courses/idmc
9/12
I still wonder if “TSC” isn’t the most helpful name, especially as some places call a “TMG” their “Steering Committee”.
This paper proposes:
>> PICTO: Partially-Independent Committee for Trial Oversight
>> SITOC: Semi-Independent Trial Oversight Committee
10/12
Bonus points for getting this far, so I'll ask you two questions
Question 1 :
What experience do you have with implementing a 3-committee trial oversight structure like the one discussed?
11/12
Broad options
-----------------------
1. None
2. Have run trials with TSC / 3rd committee
3. Have been independent member of TSC / 3rd committee
4. Both 2 and 3
What’s your preferred #ClinicalTrial #oversight committee structure in the trials you’ve been involved with? And your preferred names for each oversight committee?
12/12
Matt Parkes@Mattsydes So answers:
Q1: Have been a member of a TMG and IDMC on a few trials, have been in a number of trials with a TSC.
Broadly like the names, although I guess the names ‘TMG’ and ‘TSC’ aren’t intuitively different at first glance.
I do like this structure - the regular ‘internal’ body that runs the trial, an independent but advisory ‘scrutiny’ body and then another ‘executive’ body is a particularly useful combination when making tough decisions e.g. early closure.