I raise this paper here in hope people will use this, if they aren’t already, for #Teaching on their MSc in Clinical Trials courses , such as that run by UCL's Institute of Clinical Trials and Methodology (https://www.ucl.ac.uk/prospective-students/graduate/taught-degrees/clinical-trials-msc)

4/6

A key lesson is to specify upfront both the planned analysis and the expected direction of effect. Anything else should be noted as “exploratory”.
The full version of Figure 1 is worth exploring (abridged version here).

3/6

Importantly, it sets out a series of recommendations which we are starting to act on with HDRUK, MRC NIHR TMP, MRC CTU, BHF Data Science Centre and individuals.

7/11

The workshop was used to launch NIHR research call for data-enabled trials. Are they all doing well?

As BHF Data Science Centre Assoc Director of Data-Enabled Trials, I’m keen to facilitate greater (and appropriate) more trials using healthcare systems data.

6/11

The paper sets out some examples of trials that have already used these approaches:
>> COPE
>> DECIDE
>> @sanad2trial
>> Salford Lung Study
>> ASCEND

5/11

The work showed an academic-led #ClinicalTrial was conducted sufficient well.
Huge effort was expended by many people on retrospective verification of trial data, provoked by potential regulatory use, but these efforts had no impact on primary outcome measure: PFS

2/8

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