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Data monitoring committees: Promoting best practices to address emerging challenges.

Publication ,  Journal Article
Fleming, TR; DeMets, DL; Roe, MT; Wittes, J; Calis, KA; Vora, AN; Meisel, A; Bain, RP; Konstam, MA; Pencina, MJ; Gordon, DJ; Mahaffey, KW ...
Published in: Clin Trials
April 2017

BACKGROUND AND PURPOSE: Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. METHODS: An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees. RESULTS AND CONCLUSIONS: Prospective data monitoring committee members need better training. Options could include didactic instruction as well as apprenticeships to provide real-world experience. Data monitoring committee members should be protected against legal liability arising from their service. While avoiding breaches in confidentiality of interim data remains a high priority, data monitoring committees should have access to unblinded efficacy and safety data throughout the trial to enable informed judgments about risks and benefits. Because overly rigid procedures can compromise their independence, data monitoring committees should have the flexibility necessary to best fulfill their responsibilities. Data monitoring committee charters should articulate principles that guide the data monitoring committee process rather than list a rigid set of requirements. Data monitoring committees should develop their recommendations by consensus rather than through voting processes. The format for the meetings of the data monitoring committee should maintain the committee's independence and clearly establish the leadership of the data monitoring committee chair. The independent statistical group at the Statistical Data Analysis Center should have sufficient depth of knowledge about the study at hand and experience with trials in general to ensure that the data monitoring committee has access to timely, reliable, and readily interpretable insights about emerging evidence in the clinical trial. Contracts engaging data monitoring committee members for industry-sponsored trials should have language customized to the unique responsibilities of data monitoring committee members rather than use language appropriate to consultants for product development. Regulatory scientists would benefit from experiencing data monitoring committee service that does not conflict with their regulatory responsibilities.

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Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

April 2017

Volume

14

Issue

2

Start / End Page

115 / 123

Location

England

Related Subject Headings

  • Statistics & Probability
  • Practice Guidelines as Topic
  • Insurance
  • Humans
  • Confidentiality
  • Clinical Trials Data Monitoring Committees
  • 5203 Clinical and health psychology
  • 4905 Statistics
  • 3202 Clinical sciences
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Fleming, T. R., DeMets, D. L., Roe, M. T., Wittes, J., Calis, K. A., Vora, A. N., … Ellenberg, S. S. (2017). Data monitoring committees: Promoting best practices to address emerging challenges. Clin Trials, 14(2), 115–123. https://doi.org/10.1177/1740774516688915
Fleming, Thomas R., David L. DeMets, Matthew T. Roe, Janet Wittes, Karim A. Calis, Amit N. Vora, Alan Meisel, et al. “Data monitoring committees: Promoting best practices to address emerging challenges.Clin Trials 14, no. 2 (April 2017): 115–23. https://doi.org/10.1177/1740774516688915.
Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN, et al. Data monitoring committees: Promoting best practices to address emerging challenges. Clin Trials. 2017 Apr;14(2):115–23.
Fleming, Thomas R., et al. “Data monitoring committees: Promoting best practices to address emerging challenges.Clin Trials, vol. 14, no. 2, Apr. 2017, pp. 115–23. Pubmed, doi:10.1177/1740774516688915.
Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN, Meisel A, Bain RP, Konstam MA, Pencina MJ, Gordon DJ, Mahaffey KW, Hennekens CH, Neaton JD, Pearson GD, Andersson TL, Pfeffer MA, Ellenberg SS. Data monitoring committees: Promoting best practices to address emerging challenges. Clin Trials. 2017 Apr;14(2):115–123.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

April 2017

Volume

14

Issue

2

Start / End Page

115 / 123

Location

England

Related Subject Headings

  • Statistics & Probability
  • Practice Guidelines as Topic
  • Insurance
  • Humans
  • Confidentiality
  • Clinical Trials Data Monitoring Committees
  • 5203 Clinical and health psychology
  • 4905 Statistics
  • 3202 Clinical sciences
  • 1103 Clinical Sciences