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THE ROLE OF EXTERNAL EVIDENCE IN DATA MONITORING OF A CLINICAL TRIAL
Author(s) -
POCOCK STUART J.
Publication year - 1996
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/(sici)1097-0258(19960630)15:12<1285::aid-sim309>3.0.co;2-0
Subject(s) - interim , skepticism , clinical trial , computer science , data monitoring committee , process (computing) , randomized controlled trial , medical physics , scientific evidence , management science , medicine , epistemology , political science , law , surgery , philosophy , pathology , economics , operating system
Data 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.