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Key considerations for planning adaptive platform trials: part 1
Anders Granholm1, Morten Hylander Møller2, Aldana Rosso3
1Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark; Platform Trial Unit, Value and Coherence, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
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.
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