Effect of the Statistical Significance of Results on the Time to Completion and Publication of Randomized Efficacy Trials
JAMAPublished 28 January 1998
John P. A. Ioannidis
Citations629
SJR quartileQ1
SJR score5.35
SNIP10.71
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ObjectiveStudy objective
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TL;DR
There is a time lag in the publication of negative findings that occurs mostly after the completion of the trial follow-up among randomized efficacy trials.
Abstract
Among randomized efficacy trials, there is a time lag in the publication of negative findings that occurs mostly after the completion of the trial follow-up.
Keywords
Decision SciencesMathematics
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