The challenges of running platform trials
These three publications which explore the operational challenges of complicated clinical trials and platform protocol implementation have been published in Trials and are now available.
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. FOCUS4 is a stratified medicine study in advanced colorectal cancer led by Professor Tim Maughan at Oxford University. 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 initiated by Oxford researchers Maughan, Hordern and Morrell draws out the experiences of central trials unit staff in running these trials.
Each paper clearly sets out the strengths of these designs and frankly addresses the challenges that any group choosing to take on these designs may face. They have relevance to clinical researchers considering undertaking such studies, clinical trials units who may be called upon to coordinate them and also for research funders.