Practical implementation of new trial designs
Reviewing platform protocols: Proposed guidelines for research ethics committees (REC)
The review of platform protocols, both initially and at amendment is critically important. Sharing of information can be complex. Matt Sydes and Lou Brown ran a series of regional workshops for REC members in the UK, which informed a report to the Health Research Authority (HRA). HRA’s updated SOPs (due to be published Q2-2021) is expected to reflect these recommendations.
Hugh Davies, Research Ethics Advisor for HRA and chair of Oxford A REC, has written a blog entry on reviewing platform protocols, building out from our workshop recommendations, which can be found at the link below.
The Challenges of Running Platform Trials
The potential efficiencies of asking multiple questions in a single protocol are increasingly understood. This could be achieved using any or all of the following:
- a multi-arm multi-stage (MAMS) design to ask multiple questions from the start
- a platform (or “living”) protocol to later add in new questions in a structured way
- a biomarker-stratified design to ask questions for multiple subsets of patients with a shared screening process.
Our new papers focus on the operational considerations in undertaking such designs, drawing particularly on MRC CTU at UCL’s extensive experience with the STAMPEDE and FOCUS4 trials.
The first paper by Schiavone et al focuses on issues that trial managers or trial coordinators might have in running the operational side of these trials.
The second paper by Hague et al focuses on issues that data managers, data scientists and programmers might have in running the operational side of these trials.
The third paper by Morrell et al draws out the experiences of central trials unit staff in running these trials.
Each paper clearly sets out the strengths of these designs and addresses frankly the challenges that any group choosing to take on these designs may face. so that they can prepare well.
These papers complement our recent papers by Parmar et al and Blenkinsop et al on statistical guidelines on how to implement efficacy stopping guidelines in MAMS trials, as well as further guidance on statistical considerations in adding arms will follow soon from Oskooei et al.
Links to the three papers in Trials Journal
- Trial management paper (Schiavone et al)
- Data management systems paper (Hague et al)
- Paper about the experiences of central trials unit staff (Morrell et al)