Outcome pre-specification requires sufficient detail to guard against outcome switching in clinical trials: a case study

Abstract Background Pre-specification of outcomes is an important tool to guard against outcome switching in clinical trials. However, if the outcome is not sufficiently clearly defined, then different definitions could be applied and analysed, with only the most favourable result reported. Methods...

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Bibliographic Details
Main Authors: Brennan C. Kahan, Vipul Jairath
Format: Article
Language:English
Published: BMC 2018-05-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-018-2654-z