Moving towards a consensus on platform trial designs

20 Feb 2018
Announcement

A collaborative workshop relating to definitions of complex trial designs was successfully held on 5 February 2018 in partnership with regulatory bodies (Health Research Authority, Medicines and Healthcare products Regulatory Agency (MHRA)) and other stakeholders including the research community (ECMC, Cancer Research UK, and Clinical Trials Units), devolved administrations and industry associations (The Association of the British Pharmaceutical Industry and UK BioIndustry Association).

The origins of the workshop came from one of the outputs of the last ECMC Annual Network Meeting afternoon parallel sessions. The topic of discussion was “How do we create a conducive regulatory environment for experimental cancer medicine?” The following three areas were identified as priority regulatory themes for the network to follow-up:

  • Having clearer study definitions across the research and regulatory communities
  • Working closely with RECs
  • Agreed consensus relating to the quality of management of biomarkers.

We focused first on the issue study definition and on the workshop on 5 February, we discussed a wide range of areas and the outputs were summarised as follows:

  • It was agreed by all that the workshop should not focus on the definition of “complex” trials, but instead the operational process with the set-up and delivery associated with these types of trials.  
  • Delegates also discussed the practical complexities and solutions relating to trial amendments.
  • There was a strong case for the MHRA, through the Clinical Trials Facilitation Group (CTFG), to publish examples of assessed initial applications including any amendments received relating to key trial designs (both commercial and non-commercial). This would allow Sponsors to understand the type of trial designs assessed from the MHRA and how to submit new applications going forward.
  • There was consensus by all to use “platform” trial design as the default terminology instead of “adaptive”, “complex” or any other trial design definitions that are currently in use. Furthermore, it would be helpful to understand the common attributes found in such trial designs as part of the agreed consensus between stakeholders going forward.  

By the end of the workshop, delegates representing all interested stakeholders were keen to be involved in the development of a consensus paper (led by the ECMC Programme Office) relating to platform trial designs for publication. In turn, the paper will provide recommendations for a guidance document. Further engagement about the outputs of the workshop will also be disseminated at the 2018 ECMC Annual Network meeting in partnership with stakeholders contributing to the consensus paper. Look out for any updates from the ECMC programme office as this work progresses.

If you wish to know more please contact Ilaria Mirabile.