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

Publication ,  Journal Article
Hess, CN; Roe, MT; Gibson, CM; Temple, RJ; Pencina, MJ; Zarin, DA; Anstrom, KJ; Alexander, JH; Sherman, RE; Fiedorek, FT; Mahaffey, KW ...
Published in: Am Heart J
August 2014

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.

Duke Scholars

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

August 2014

Volume

168

Issue

2

Start / End Page

135 / 41.e1

Location

United States

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Humans
  • Communication
  • Clinical Trials Data Monitoring Committees
  • Cardiovascular System & Hematology
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
  • 1102 Cardiorespiratory Medicine and Haematology
 

Citation

APA
Chicago
ICMJE
MLA
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Hess, C. N., Roe, M. T., Gibson, C. M., Temple, R. J., Pencina, M. J., Zarin, D. A., … Califf, R. M. (2014). Independent data monitoring committees: preparing a path for the future. Am Heart J, 168(2), 135-41.e1. https://doi.org/10.1016/j.ahj.2014.05.003
Hess, Connie N., Matthew T. Roe, C Michael Gibson, Robert J. Temple, Michael J. Pencina, Deborah A. Zarin, Kevin J. Anstrom, et al. “Independent data monitoring committees: preparing a path for the future.Am Heart J 168, no. 2 (August 2014): 135-41.e1. https://doi.org/10.1016/j.ahj.2014.05.003.
Hess CN, Roe MT, Gibson CM, Temple RJ, Pencina MJ, Zarin DA, et al. Independent data monitoring committees: preparing a path for the future. Am Heart J. 2014 Aug;168(2):135-41.e1.
Hess, Connie N., et al. “Independent data monitoring committees: preparing a path for the future.Am Heart J, vol. 168, no. 2, Aug. 2014, pp. 135-41.e1. Pubmed, doi:10.1016/j.ahj.2014.05.003.
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. Independent data monitoring committees: preparing a path for the future. Am Heart J. 2014 Aug;168(2):135–41.e1.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

August 2014

Volume

168

Issue

2

Start / End Page

135 / 41.e1

Location

United States

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Humans
  • Communication
  • Clinical Trials Data Monitoring Committees
  • Cardiovascular System & Hematology
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
  • 1102 Cardiorespiratory Medicine and Haematology