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<p>Platform trials have become widely adopted across multiple disease areas over recent years, however, guidelines for operationalising these trials have not kept pace. We outline a series of documents that summarise the statistical components, and implicit processes, of the <i>Staphylococcus aureus</i> Network Adaptive Platform (SNAP) trial to provide an informal template for other researchers and reviewers of platform trials. We briefly summarise the content and role of the core protocol, statistical appendix, domain-specific appendices, simulation report, statistical implementation guides, data safety and monitoring committee (DSMC) reports, and domain-specific statistical analysis plans and final reports, and a transparent governance structure that ensures separate blinded and unblinded statistical teams. In the absence of guidelines or checklists for platform trial statistical documents, we hope to provide useful guidance to others in terms of what has worked so far for the SNAP trial, stimulate discussion, and inform a future consensus.</p><p><b>Trial registration</b> <a href="https://clinicaltrials.gov/ct2/show/NCT05137119">NCT05137119</a>. Registered on 30 November 2021.</p>

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Statistical documentation for multi-disease, multi-domain platform trials: our experience with the Staphylococcus aureus Network Adaptive Platform trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年2月11日

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  • Robert K. Mahar,
  • Anna McGlothlin,
  • Michael Dymock,
  • Lauren Barina,
  • Marc Bonten,
  • Asha Bowen,
  • Matthew P. Cheng,
  • Nick Daneman,
  • Anna L. Goodman,
  • Todd C. Lee,
  • Roger J. Lewis,
  • Thomas Lumley,
  • Alistair R. D. McLean,
  • Zoe McQuilten,
  • Jocelyn Mora,
  • David L. Paterson,
  • David J. Price,
  • Jason Roberts,
  • Tom Snelling,
  • Jonas Tverring,
  • Steve A. Webb,
  • Dafna Yahav,
  • Joshua S. Davis,
  • Steven Y. C. Tong,
  • Julie A. Marsh,
  • Tom Boyles,
  • Catherine Cosgrove,
  • George Heriot,
  • Marjolein Hensgens,
  • David Lye,
  • Susan Morpeth,
  • Owen Robinson,
  • Hiroki Saito,
  • Matthew Scarborough,
  • Sebastiaan van Hal,
  • Genevieve Walls,
  • Lynda Whiteway

摘要

Platform trials have become widely adopted across multiple disease areas over recent years, however, guidelines for operationalising these trials have not kept pace. We outline a series of documents that summarise the statistical components, and implicit processes, of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial to provide an informal template for other researchers and reviewers of platform trials. We briefly summarise the content and role of the core protocol, statistical appendix, domain-specific appendices, simulation report, statistical implementation guides, data safety and monitoring committee (DSMC) reports, and domain-specific statistical analysis plans and final reports, and a transparent governance structure that ensures separate blinded and unblinded statistical teams. In the absence of guidelines or checklists for platform trial statistical documents, we hope to provide useful guidance to others in terms of what has worked so far for the SNAP trial, stimulate discussion, and inform a future consensus.

Trial registration NCT05137119. Registered on 30 November 2021.