Data monitoring committee interim reports: We must get there soon

• Published in: Clinical trials (London, England) Vol. 19; no. 1; p. 107
• Main Authors: DeMets, David L, Wittes, Janet
• Format: Journal Article
• Language: English
• Published: England 01.02.2022
• Subjects: Clinical Trials Data Monitoring Committees; Humans; interim statistical reports; data monitoring committee
• ISSN: 1740-7753
• DOI: 10.1177/17407745211051279

Currently, too many Data Monitoring Committee Reports for interim review of trial progress are quite inadequate for Data Monitoring Committees to make informed decisions about risks and benefits. Immediate serious improvement is necessary for Data Monitoring Committees to meet their ethical, clinical, and scientific responsibility to trial participants, investigators, sponsors, and participating institutions. To achieve this critical goal, all parties involved in the Data Monitoring Committee process including sponsors, investigators, Data Monitoring Committee members, and the independent statistical reporting group need to have a better understanding of the structure, function, and needs of a Data Monitoring Committee and the content of a Data Monitoring Committee Report. Training modules through the Society for Clinical Trials are now available on their website to facilitate this.