Data Monitoring Committees (DMC)

This article describes the objectives, membership, creation, and organization of a data monitoring committee in industry-sponsored clinical trials. Both safety and efficacy monitoring are included as are a description of the charter, conflicts of interest, clinical, regulatory and statistical issues/ methods, multiregional trials, use of MedDRA and standard MedDRA queries, sources of bias, and types and methods of decisions made by data monitoring committees including interim analyses for superiority and futility. The article concludes with emerging issues including adaptive designs, novel designs in oncology, centralized risk-based monitoring, fraud detection, and training of committee members.