Independent data monitoring committees: preparing a path for the future.

Published

Journal Article

Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs.

Full Text

Duke Authors

Cited Authors

  • Hess, CN; Roe, MT; Gibson, CM; Temple, RJ; Pencina, MJ; Zarin, DA; Anstrom, KJ; Alexander, JH; Sherman, RE; Fiedorek, FT; Mahaffey, KW; Lee, KL; Chow, S-C; Armstrong, PW; Califf, RM

Published Date

  • August 2014

Published In

Volume / Issue

  • 168 / 2

Start / End Page

  • 135 - 41.e1

PubMed ID

  • 25066551

Pubmed Central ID

  • 25066551

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2014.05.003

Language

  • eng

Conference Location

  • United States