• Statistics in medicine · Jun 1996

    Review

    The role of external evidence in data monitoring of a clinical trial.

    • S J Pocock.
    • Medical Statistics Unit, London School of Hygiene and Tropical Medicine, U.K.
    • Stat Med. 1996 Jun 30; 15 (12): 1285-93; discussion 1295-7.

    AbstractData monitoring of interim results from a randomized clinical trial should take into consideration evidence from other trials. This article presents both scientific and practical issues regarding the pros and cons of formally incorporating such external evidence into the decision making process for the current trial. Guidelines on how to use other trials' data are presented, along with cautiously sceptical comments on the impracticality of using formal meta-analyses in data monitoring. The arguments are illustrated by recent examples from specific trials, and the article concludes with some general recommendations.

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