title: Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?
abstract: It has long been a fundamental principle of clinical trials that interim comparative data should be kept confidential, with such data accessible only to a small number of individuals responsible for its analysis and monitoring. The rationale for keeping investigators and sponsors blinded to interim data has been extensively discussed, but the possible conflicts of interest that could arise for the statistician who performs the analysis of the interim data and presents it to a data monitoring committee has received little attention. We describe these potential conflicts, and the advantages and disadvantages of approaches that might be taken to minimize them. We have invited commentary on this issue from several statisticians with substantial experience in clinical trials and interim data monitoring.
authors.affiliation: Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA. ellenberg@cber.fda.gov
authors.forename: Susan S
authors.initials: SS
authors.lastname: Ellenberg
authors.forename: Stephen L
authors.initials: SL
authors.lastname: George
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics* / Q000592:standards; D016265:Conflict of Interest; D003627:Data Interpretation, Statistical; D004995:Ethics, Professional; D017408:Guidelines as Topic; D006801:Humans; D008137:Longitudinal Studies; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000592:standards; D012108:Research Personnel / Q000941:ethics; D013223:Statistics as Topic / Q000941:ethics*; D014481:United States; D014486:United States Food and Drug Administration