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Early stopping of a randomised trial for efficacy: a medical, ethical and regulatory challenge

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  • Contributors AD and GD participated in the writing and editing of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests AD discloses the following: research grants from Abbott and travel fees by AlviMedica and Bayer. GD discloses speaker’s and/or consulting fees from Amgen, AstraZeneca, Bayer, BMS, Janssen, Sanofi and Terumo.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Commissioned; externally peer reviewed.

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