Key considerations for planning adaptive platform trials: part 1.

BACKGROUND There is increased interest in adaptive platform trials (APTs), i.e., complex randomised clinical trials (RCTs) focusing on a population or a setting, conducted according to a core protocol, with continuous addition of interventions during trial conduct. APTs may run perpetually, assessing many different interventions. APTs come with benefits regarding increased flexibility, efficiency, and cost-effectiveness compared to conventional, stand-alone RCTs. However, planning APTs is complex, and limited guidance is available. METHODS In this two-part series, we provide a narrative overview of key considerations for the planning of APTs in a clinical setting based on our own experiences planning and initiation APTs. RESULTS This first part covers the following 5 overall considerations: stakeholder involvement; population and setting; interventions and comparisons; clinical outcomes; and adaptations. The second part covers 7 additional overall considerations: statistics and performance; other design features; data infrastructure; operations and organisation; funding; dissemination; and implementation. CONCLUSION The provided guidance on key considerations when planning APTs will aid researchers considering or planning APTs.