title: Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees.
abstract: This is a commissioned report by a writing committee formed by the Society for Clinical Trials. The committee was formed with the objectives of 1) reviewing data monitoring guidelines for confirmatory (phase III) trials published by the National Institutes of Health, US Food and Drug Administration, Veterans Administration, and the International Conference on Harmonisation and 2) proposing corresponding guidelines for exploratory clinical trials (ie, most phase I and phase II trials and others not requiring a fully independent data monitoring committee). These trials typically involve fewer subjects and are of shorter duration than phase III trials. Nevertheless there are safety concerns, especially because these are often the first human trials for a new intervention. Recommendations are given for appropriate elements of a data monitoring plan, decision criteria for institution of a data monitoring committee (DMC), and critical elements for a DMC to consider in exploratory trials. Review and approval of data monitoring plans are suggested to fall under Institutional Review Board purview. Forming a committee with all the characteristics of a traditional phase III trial monitoring committee may be warranted for a small fraction of exploratory trials. Such a panel could consist of both trial investigators and outside members. The paper concludes with examples of data and safety monitoring practice from the University of Wisconsin Comprehensive Cancer Center and the AIDS Clinical Trials Groups.
authors.affiliation: National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. dd23a@nih.gov
authors.forename: Dennis O
authors.initials: DO
authors.lastname: Dixon
authors.forename: Ralph S
authors.initials: RS
authors.lastname: Freedman
authors.forename: Jay
authors.initials: J
authors.lastname: Herson
authors.forename: Michael
authors.initials: M
authors.lastname: Hughes
authors.forename: KyungMann
authors.initials: K
authors.lastname: Kim
authors.forename: Michael H
authors.initials: MH
authors.lastname: Silverman
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Tangen
mesh_terms: D000163:Acquired Immunodeficiency Syndrome; D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D008495:Medical Oncology; D009316:National Institutes of Health (U.S.); D014481:United States