Practical guidance for running late-phase platform trials

26 Oct 2022

In a new study, experts from clinical trial units in the UK have published practical guidance on how to improve the conduct of platform trials. The paper was published open access in Trials early this month.

Platform trials are a relatively new methodology. Passing on trial conduct experience from those who have successfully carried out these trials will enable future trials to be well run.

In an effort to improve platform trials conduct, our methodology experts held a meeting in 2019 which many professionals with experience in running platform trials attended. They presented their experience and together all discussed the points crucial for platform trials. The attendees worked at six UK Clinical Research Collaboration (UKCRC)-registered trials units.

Some examples that were reviewed include:

• Protocol - State in the protocol that future comparisons will be incorporated into the protocol if appropriate
• Patient and Public Involvement (PPI) - Comparison‑specific PPI representation can give a more manageable workload for PPI members and enable trial teams to better support PPI members.
• Trial Management Group (TMG) - The responsibilities of large TMGs may usefully be delegated to specific sub-committees, each responsible for components of the platform

We compiled recommendations discussed at the workshop and wrote a practical guidance paper. You can read the full report here.

The trial conduct methodology team is now looking to discuss differences or gaps between this work and the experience of those conducting UK platform trials started in 2018 as well as international trials.

Please contact Sharon Love s.love@ucl.ac.uk if you have set up a platform trial since 2018 in the UK or worldwide.

List of contributors, from UK Clinical Research Collaboration (UKCRC)-registered trials units:

• Centre for Trials Research, Cardiff
• CRUK Clinical Trials Unit Glasgow
• CRUK Clinical Trials Unit, Birmingham
• ICR-CTSU, Sutton
• Leeds Institute of Clinical Trials Research
• MRC Clinical Trials Unit at UCL

Further information:

• Paper in Trials
• Relevant papers on MAMS trials:
  • 'Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons'
  • 'This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols'
  • 'Mind the gap? The platform trial as a working environment'
• MAMS Clinic
• MAMS course