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?

• Published in: Statistics in medicine Vol. 23; no. 10; pp. 1507 - 1511
• Main Author: Bryant, John
• Format: Journal Article
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 30.05.2004; Wiley Subscription Services, Inc
• Subjects: Antineoplastic Agents - therapeutic use; blinding data; Breast Neoplasms - drug therapy; Clinical trials; Clinical Trials Data Monitoring Committees - ethics; Clinical Trials Data Monitoring Committees - standards; Clinical Trials, Phase III as Topic - ethics; Clinical Trials, Phase III as Topic - standards; co-operative groups; Committees; Data Collection - ethics; Data Collection - standards; Data Interpretation, Statistical; Data Monitoring Committees; Data Safety Monitoring Boards; Data Safety Monitoring Committees; DMC; DSMB; DSMC; Ethics, Professional; Female; group sequential interim policies; Humans; interim analyses; National Institutes of Health (U.S.) - ethics; National Institutes of Health (U.S.) - standards; phase III clinical trials; Research Subjects; Statistical analysis; Statistical methods; Statistics as Topic - ethics; Survival Analysis; United States; United States; Biomedical and Behavioral Research
• ISSN: 0277-6715; 1097-0258
• DOI: 10.1002/sim.1785

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. Copyright 2004 John Wiley & Sons, Ltd.