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Practical aspects in data monitoring: A brief review
Author(s) -
Demets David L.
Publication year - 1987
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.4780060706
Subject(s) - interim , interim analysis , clinical trial , computer science , type i and type ii errors , medical physics , medicine , statistics , mathematics , archaeology , history
Monitoring interim accumulating data in a clinical trial for evidence of therapeutic benefit or toxicity is a frequent policy, usually carried out by an independent scientific committee. Repeated testing at conventional critical values can substantially inflate the type I error rate. To maintain acceptable levels, group sequential and stochastic curtailment have been developed for clinical trials. One should not view such methods as absolute rules, but as useful guides. The decision process to terminate a trial early is complex and necessitates an accounting for many factors. The Beta‐Blocker Heart Attack Trial provides an excellent example of many of these issues.