Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE

Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE

Introduction Randomised controlled trials (RCTs) may use surrogate endpoints as substitutes and predictors of patient-relevant/participant-relevant final outcomes (eg, survival, health-related quality of life). Translation of effects measured on a surrogate endpoint into health benefits for patients...

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Bibliographic Details
Main Authors: Martin Offringa, Nancy J Butcher, Derek Stewart, An-Wen Chan, Oriana Ciani, Philippa Davies, Christopher J Weir, Mario Ouwens, Dalia Dawoud, Sylwia Bujkiewicz, Anthony Muchai Manyara
Format: Article
Language:English
Published: BMJ Publishing Group 2022-10-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/10/e064304.full

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https://bmjopen.bmj.com/content/12/10/e064304.full

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