Early Termination of Clinical Trials May Overestimate Treatment Effects

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Early termination of clinical trials may overestimate treatment effects, according to the results of a systematic review and meta-regression analysis reported in the...Journal of the American Medical Association.

"Although randomized controlled trials (RCTs) generally provide credible evidence of treatment effects, multiple problems may emerge when investigators terminate a trial earlier than planned, especially when the decision to terminate the trial is based on the finding of an apparently beneficial treatment effect," write Dirk Bassler, MD, MSc, from McMaster University in Hamilton, Ontario, Canada, and colleagues from the Study of Policy of Interim Truncation 2 Study Group. "Bias may arise because large random fluctuations of the estimated treatment effect can occur, particularly early in the progress of a trial. When investigators stop a trial based on an apparently beneficial treatment effect, their results may therefore provide misleading estimates of the benefit."

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