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J Clin Epidemiol. 2008 Mar;61(3):241-6. doi: 10.1016/j.jclinepi.2007.07.016.

Early stopping of randomized clinical trials for overt efficacy is problematic.

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  • 1Department of Neonatology, University Children's Hospital, Tübingen, Germany.

Abstract

OBJECTIVE:

To illustrate controversial issues associated with stopping randomized controlled trials (RCTs) early for apparent benefit.

STUDY DESIGN AND SETTING:

The article presents our review of prior relevant work and our research group's reflections on early stopping.

RESULTS:

Compelling evidence suggests that trials stopped early for benefit systematically overestimate treatment effects, sometimes by a large amount. Unresolved controversies in trials stopped early for benefit include ethical and statistical problems in the interpretation of results.

CONCLUSIONS:

The best strategy to minimize the problems associated with early stopping of RCTs for benefit is not to stop early. As an alternative, we suggest a threefold approach: a low P-value as the threshold for stopping at the time of interim analyses, not to look before a sufficiently large number of events has accrued and continuation of enrollment and follow-up for a further period.

PMID:
18226746
DOI:
10.1016/j.jclinepi.2007.07.016
[PubMed - indexed for MEDLINE]
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