title: What is the appropriate role of the trial statistician in preparing and presenting interim findings to an independent Data Monitoring Committee in the U.S. Cancer Cooperative Group setting?
abstract: A recent draft FDA Guidance on the establishment and operation of clinical trial Data Monitoring Committees (DMCs) suggests that statisticians who prepare and present interim analyses to the DMC should be external to the trial sponsor. In the context of the National Cancer Institute (NCI) Cooperative Group program, this recommendation appears to imply that Group study statisticians should be blinded to interim data and excluded from the interim monitoring process in all Cooperative Group trials. In this commentary, it is argued that the benefits of such a policy would be minimal in the Cooperative Group setting and are far outweighed by the tangible benefits of including the study statistician in the monitoring process.
authors.affiliation: Department of Biostatistics and Statistics and National Surgical Adjuvant Breast and Bowel Project Biostatistical Center, University of Pittsburgh, Pittsburgh PA 15213, USA. bryant@nsabp.pitt.edu
authors.forename: John
authors.initials: J
authors.lastname: Bryant
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy; D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics* / Q000592:standards; D017326:Clinical Trials, Phase III as Topic / Q000941:ethics* / Q000592:standards; D003625:Data Collection / Q000941:ethics / Q000592:standards; D003627:Data Interpretation, Statistical; D004995:Ethics, Professional; D005260:Female; D006801:Humans; D009316:National Institutes of Health (U.S.) / Q000941:ethics* / Q000592:standards; D035842:Research Subjects; D013223:Statistics as Topic / Q000941:ethics*; D016019:Survival Analysis; D014481:United States
chemical_list: D000970:Antineoplastic Agents