PMID: 3321314Oct 1, 1987Paper

Practical aspects in data monitoring: a brief review

Statistics in Medicine
D L DeMets

Abstract

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.

Associated Clinical Trials

References

Sep 1, 1986·Statistics in Medicine·D J Spiegelhalter
Mar 1, 1986·Controlled Clinical Trials·D J SpiegelhalterP R Blackburn
Oct 1, 1971·The British Journal of Radiology·J L Haybittle
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Mar 26, 1982·JAMA : the Journal of the American Medical Association

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Citations

Jun 1, 1993·Controlled Clinical Trials·T R Fleming, D L DeMets
Jul 2, 2003·American Journal of Ophthalmology·Joseph F CollinsUNKNOWN Department of Veterans Affairs Cooperative Cataract Study
Sep 5, 2003·The New England Journal of Medicine·Paul J FudalaUNKNOWN Buprenorphine/Naloxone Collaborative Study Group
Nov 1, 1991·The Australian & New Zealand Journal of Obstetrics & Gynaecology·A L SpeirsS J Silber
Jul 15, 1994·Statistics in Medicine·D L DeMets, K K Lan
Jan 19, 2011·Expert Opinion on Drug Metabolism & Toxicology·Michel Adamina, Markus Joerger
Apr 2, 2004·Statistics in Medicine·Y H Joshua ChenK K Gordon Lan
Oct 1, 1989·Statistics in Medicine·D L Demets
Jun 1, 1992·Japanese Journal of Cancer Research : Gann·S PiantadosiT Tamura
Sep 27, 2002·Statistics in Medicine·Allan Donner, Neil Klar
Feb 24, 2018·The Cochrane Database of Systematic Reviews·Angela L ChiewNick A Buckley
Apr 15, 2011·The Cochrane Database of Systematic Reviews·Yun XiaChristian Gluud
May 2, 2013·The Cochrane Database of Systematic Reviews·Yun XiaChristian Gluud
Aug 16, 2014·The Cochrane Database of Systematic Reviews·Eugene J Kongnyuy, Charles Shey Wiysonge
Apr 21, 2006·The Cochrane Database of Systematic Reviews·J BrokC Gluud
Oct 21, 2006·The Cochrane Database of Systematic Reviews·A Rambaldi, C Gluud
Oct 19, 2007·The Cochrane Database of Systematic Reviews·A RambaldiC Gluud
Nov 12, 2005·Clinical Trials : Journal of the Society for Clinical Trials·Matthew R SydesUNKNOWN DAMOCLES Group
Nov 13, 2015·The Cochrane Database of Systematic Reviews·Andrea Rambaldi, Christian Gluud

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