Randomized trials addressing a similar question are commonly published after a trial stopped early for benefit.
Murad MH, Guyatt GH, Domecq JP, Vernooij RWM, Erwin PJ, Meerpohl JJ, Prutsky GJ, Akl EA, Mueller K, Bassler D, Schandelmaier S, Walter SD, Busse JW, Kasenda B, Pagano G, Pardo-Hernandez H, Montori VM, Wang Z, Briel M. Randomized trials addressing a similar question are commonly published after a trial stopped early for benefit. J Clin Epidemiol. 2017 Feb;82:12-19.
Journal of clinical epidemiology
OBJECTIVE: We 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 SETTING: We searched multiple databases from the date of publication of the truncated trial through August, 2015. Independent reviewers selected trials and extracted data.
RESULTS: We 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).
CONCLUSION: About 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.
Medical Subject Headings
Databases, Factual; Early Termination of Clinical Trials; Epidemiologic Studies; Humans; Publishing; Randomized Controlled Trials as Topic