title: Independent data monitoring committees: preparing a path for the future.
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.
authors: Duke Clinical Research Institute, Durham, NC.
authors: Connie N
authors: CN
authors: Hess
authors: Duke Clinical Research Institute, Durham, NC. Electronic address: matthew.roe@duke.edu.
authors: Matthew T
authors: MT
authors: Roe
authors: PERFUSE Study Group, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
authors: C Michael
authors: CM
authors: Gibson
authors: US Food and Drug Administration, Silver Spring, MD.
authors: Robert J
authors: RJ
authors: Temple
authors: Duke Clinical Research Institute, Durham, NC.
authors: Michael J
authors: MJ
authors: Pencina
authors: National Institutes of Health, Bethesda, MD.
authors: Deborah A
authors: DA
authors: Zarin
authors: PERFUSE Study Group, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
authors: Kevin J
authors: KJ
authors: Anstrom
authors: Duke Clinical Research Institute, Durham, NC.
authors: John H
authors: JH
authors: Alexander
authors: US Food and Drug Administration, Silver Spring, MD.
authors: Rachel E
authors: RE
authors: Sherman
authors: Bristol-Myers Squibb, New York, NY.
authors: Fred T
authors: FT
authors: Fiedorek
authors: Department of Medicine, Stanford University, Stanford, CA.
authors: Kenneth W
authors: KW
authors: Mahaffey
authors: Duke Clinical Research Institute, Durham, NC.
authors: Kerry L
authors: KL
authors: Lee
authors: Duke University School of Medicine, Durham, NC.
authors: Shein-Chung
authors: SC
authors: Chow
authors: University of Alberta, Edmonton, Alberta, Canada.
authors: Paul W
authors: PW
authors: Armstrong
authors: Duke University School of Medicine, Durham, NC.
authors: Robert M
authors: RM
authors: Califf
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000191:economics / Q000458:organization & administration / Q000592:standards / Q000706:statistics & numerical data / Q000639:trends; D003142:Communication; D006801:Humans; D016032:Randomized Controlled Trials as Topic