Article ID Journal Published Year Pages File Type
5121818 Journal of Clinical Epidemiology 2017 8 Pages PDF
Abstract

ObjectiveWe explored how investigators of ongoing or planned trials respond to the publication of a trial stopped early for benefit addressing a similar question.Study Design and SettingWe searched multiple databases from the date of publication of the truncated trial through August, 2015. Independent reviewers selected trials and extracted data.ResultsWe identified 207 trials truncated for early benefit; of which 102 (49%) were followed by subsequent trials (262 subsequent trials, median 2 per truncated trial, range 1-13). Only 99 (38%) provided a rationale justifying conducting a trial despite prior stopping. The top reasons were to address different population or setting (33%), skepticism of truncated trials findings because of small sample size (12%), inconsistency with other evidence (11%), or increased risk of bias (7%). We did not identify significant associations between subsequent trials and characteristics of truncated ones (risk of bias, precision, funding, or rigor of stopping decision).ConclusionAbout half of the trials stopped early for benefit were followed by subsequent trials addressing a similar question. This suggests that future trialists may have been skeptic about the decision to stop prior trials. A more rigorous threshold for stopping early for benefit is needed.

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