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Statistical and ethical issues in monitoring clinical trials
Author(s) -
Pocock Stuart J.
Publication year - 1993
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/sim.4780121512
Subject(s) - interim , data monitoring committee , dilemma , clinical trial , context (archaeology) , ethical dilemma , relevance (law) , randomized controlled trial , ethical issues , interim analysis , computer science , medicine , engineering ethics , political science , law , epistemology , paleontology , philosophy , surgery , pathology , biology , engineering
Most randomized clinical trials require periodic monitoring of the accumulating data. While the efficiency of trial management is enhanced by data monitoring, ethical reasons should primarily dictate the need to terminate or change a trial in response to interim findings. This article focuses on the ethical dilemma of when to stop a clinical trial and places statistical stopping rules in the context of such ethical decision making. Other issues include the organization of data monitoring committees and the problems of premature publication and exaggerated estimation in trials that stop early. Several topical examples are used to convey the relevance of these issues to current practice.