Key considerations for planning adaptive platform trials: part 1

Le résumé fourni par la source

BACKGROUND AND OBJECTIVES: There is an increased interest in adaptive platform trials (APTs), that is, complex randomized 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 organization, funding, dissemination, and implementation. CONCLUSION: The provided guidance on key considerations when planning APTs will aid researchers considering or planning APTs.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.