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Describing the Endpoint: Consistency Across Protocols, Study Reports, Postings, and Publications

  • Clinical Trials: Analytical Report
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Abstract

Endpoints are the cornerstone of clinical trial design and are the critical elements for evaluating the success of a clinical study. Endpoints are communicated in clinical protocols, study reports, study registration and result posting sites, as well as publications. It is, therefore, important that endpoints are presented consistently, correctly, and completely. The FDAAA Final Rule expectations of describing endpoints in specific terms provides a way to keep this consistency across all documents.

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Authors and Affiliations

  1. One MedImmune Way, MedImmune, LLC, Gaithersburg, MD, 20870, USA

    Yeshi Mikyas PhD

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  1. Yeshi Mikyas PhD
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Correspondence to Yeshi Mikyas PhD.

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Mikyas, Y. Describing the Endpoint: Consistency Across Protocols, Study Reports, Postings, and Publications. Ther Innov Regul Sci 51, 304–306 (2017). https://doi.org/10.1177/2168479016682342

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  • DOI: https://doi.org/10.1177/2168479016682342

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