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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.

Journal of Clinical Epidemiology
|March 9, 2026
PubMed
Summary
This summary is machine-generated.

Adaptive platform trials (APTs) offer flexibility and efficiency in clinical research but are complex to plan. This guide provides essential considerations for researchers designing these complex randomized clinical trials.

Keywords:
Adaptive platform trialGuidanceMethodsRandomised clinical trialStakeholder involvementTrial design

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Area of Science:

  • Clinical Trials Methodology
  • Adaptive Trial Design

Background:

  • Growing interest in adaptive platform trials (APTs) for complex clinical research.
  • APTs offer enhanced flexibility, efficiency, and cost-effectiveness over traditional trials.
  • Limited guidance currently exists for planning APTs.

Purpose of the Study:

  • To provide a narrative overview of key planning considerations for adaptive platform trials.
  • To offer guidance based on practical experience in initiating APTs.

Main Methods:

  • A two-part series detailing essential planning aspects of APTs.
  • Focus on a narrative overview of critical considerations.

Main Results:

  • Part one covers stakeholder involvement, population, interventions, outcomes, and adaptations.
  • Part two will address statistics, design features, data, operations, funding, dissemination, and implementation.

Conclusions:

  • This guidance aims to assist researchers in planning adaptive platform trials.
  • Key considerations are presented to facilitate the successful design and initiation of APTs.