Changes to aspects of ongoing randomised controlled trials with fixed designs

Changes to aspects of ongoing randomised controlled trials with fixed designs

Abstract Background Despite careful planning, changes to some aspects of an ongoing randomised clinical trial (RCT), with a fixed design, may be warranted. We sought to elucidate the distinction between legitimate versus illegitimate changes to serve as a guide for less experienced clinical trialist...

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Bibliographic Details
Main Authors: Xanthi Coskinas, John Simes, Manjula Schou, Andrew James Martin
Format: Article
Language:English
Published: BMC 2020-06-01
Series:Trials
Subjects:
Randomised control trials
Bias
Design changes
Type 1 error
Online Access:http://link.springer.com/article/10.1186/s13063-020-04374-3

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