title: The independent statistician for data monitoring committees.
abstract: Clinical trials are an essential part of the clinical research process. Recently, independent Data Monitoring Committees (DMCs) have been widely implemented to provide scientific and ethical oversight of pivotal clinical trials having irreversible outcomes such as death, stroke, disease recurrence or a serious adverse event. To carry out their responsibility, the DMC reviews interim analyses of accumulating data. We address the motivation for having the preparation and presentation of these interim analyses be conducted by an independent statistician who is not a member of the DMC and who is not the trial's lead or steering committee statistician. These views are based on having served as members of many DMCs as well as having been the independent statistician for several trials.
authors.affiliation: Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, 600 Highland Avenue, Box 4675, Madison, WI 53792-4675, USA. demets@biostat.wisc.edu
authors.forename: David L
authors.initials: DL
authors.lastname: DeMets
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Fleming
mesh_terms: D015982:Bias; D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics* / Q000592:standards; D003627:Data Interpretation, Statistical; D004995:Ethics, Professional; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics* / Q000592:standards; D009316:National Institutes of Health (U.S.) / Q000941:ethics / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000592:standards; D013223:Statistics as Topic / Q000941:ethics*; D016896:Treatment Outcome; D014481:United States