When (Not) to Stop a Clinical Trial for Benefit
- Stuart J. Pocock, PhD
- Author Affiliation: Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London, England.
- Corresponding Author: Stuart J. Pocock, PhD, Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel St, London WC1E 7HT, England (stuart.pocock{at}lshtm.ac.uk).
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- DECISION MAKING
- ETHICS, MEDICAL
- RANDOMIZED TRIALS
In this issue of JAMA, Montori and colleagues1 provide a valuable extensive and critical systemic review of clinical trials that were stopped early for benefit. Readers of the reports of such trials often feel a sense of excitement, especially when phrases such as “a major treatment advance,” “ethical need to stop the inferior treatment,” and “vital to tell the world immediately” are used. However, experience suggests that early results and enthusiasm, especially for modestly sized trials terminated early for apparent major benefit, are often moderated as subsequent reports arise.2
The skeptic should ask first whether correct and appropriate structures were in place for analyzing and reviewing, and making decisions based on, the trial’s accumulating interim data. Having the members of an effective independent data monitoring committee (DMC) or data and safety monitoring board as the only individuals accessing and interpreting interim data split by treatment group is …
