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. 2014 Aug;168(2):135-41.e1.
doi: 10.1016/j.ahj.2014.05.003. Epub 2014 May 15.

Independent data monitoring committees: preparing a path for the future

Connie N Hess  1 , Matthew T Roe  2 , C Michael Gibson  3 , Robert J Temple  4 , Michael J Pencina  1 , Deborah A Zarin  5 , Kevin J Anstrom  3 , John H Alexander  1 , Rachel E Sherman  4 , Fred T Fiedorek  6 , Kenneth W Mahaffey  7 , Kerry L Lee  1 , Shein-Chung Chow  8 , Paul W Armstrong  9 , Robert M Califf  8
Affiliations

Independent data monitoring committees: preparing a path for the future

Connie N Hess et al. Am Heart J. 2014 Aug.

Abstract

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.

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Conflict of interest statement

Potential conflicts of interest: MT Roe: available at https://dcri.org/about-us/conflict-of-interest. MJ Pencina: serves/has served on the following data safety monitoring boards for the following sponsors: Theracos, DC Devices, Amorcyte, Cardiovascular Science Foundation, AbbVie (past), and Aspire (past). JH Alexander: available at https://dcri.org/about-us/conflict-of-interest. FT Fiedorek: is a full-time employee in the Bristol-Myers Squibb R&D organization and a holder of BMS stock. KW Mahaffey: full disclosures before August 1, 2013 available at www.dcri.org; disclosures after August 1, 2013 available at http://med.stanford.edu/profiles/kenneth_mahaffey. PW Armstrong: reports receiving consulting fees from Bayer, Eli Lilly, Roche, Merck, Axio, Regado Biosciences, and Orexigen; grant funding from Boehringer Ingelheim, Sanofiaventis, Scios, Regado Biosciences, GlaxoSmithKline, Amylin, and Merck; and payment for developing educational presentations from AstraZeneca. RM Califf: available at https://dcri.org/about-us/conflict-of-interest. The remaining authors have nothing to disclose.

Figures

Figure
Figure
Independent data monitoring committee communication pathways. ARO, academic research organization; CRO, commercial research organization; EC, executive committee; IDC, independent data center.
See this image and copyright information in PMC

References

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