title: Data monitoring committees and interim monitoring guidelines.
abstract: Most large randomized clinical trials have a data monitoring committee that periodically examines efficacy and safety results. A typical data monitoring committee meets every 6 months, but the interim monitoring guidelines for many trials specify formal analyses that are years apart. In this article we argue that study protocols should include monitoring guidelines with formal looks at each data monitoring committee meeting. Such guidelines are shown to reduce the average duration of a trial with negligible effect on power and estimation bias. Some of the common statistical monitoring guidelines require extreme evidence to stop a trial early and do not distinguish between stopping a trial during active accrual and follow-up stages. We propose practical solutions for these issues.
authors.affiliation: Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892, USA.
authors.forename: B
authors.initials: B
authors.lastname: Freidlin
authors.forename: E L
authors.initials: EL
authors.lastname: Korn
authors.forename: S L
authors.initials: SL
authors.lastname: George
mesh_terms: D001499:Bayes Theorem; D003627:Data Interpretation, Statistical; D017408:Guidelines as Topic; D006801:Humans; D011367:Professional Staff Committees; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data