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The Article in Brief
Undisclosed Changes in Outcomes in Randomized Controlled Trials: An Observational Study
Robert Ewart , and colleagues
Background Changing the outcomes of a clinical trial, without explanation, calls its validity into question. This study examines how often outcomes are changed between trial registration and final publication.
What This Study Found Authors frequently change the outcomes of clinical trials between trial registration and publication without explanation or disclosure. Analyzing 110 randomized controlled trials published in consecutive issues of five major medical journals in a six-month period and their associated trial registry entries, researchers found that a primary outcome had been changed in 34 (31 percent) of the articles and a secondary outcome was changed in 77 (70 percent) without disclosure.
Implications
- The authors assert that allowing researchers to change their outcomes without reason or disclosure threatens the underpinnings of the scientific enterprise and the ability of practicing physicians to apply published research to patient care.