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Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job.

Publication ,  Journal Article
Evans, SR; Bigelow, R; Chuang-Stein, C; Ellenberg, SS; Gallo, P; He, W; Jiang, Q; Rockhold, F
Published in: Ann Intern Med
January 21, 2020

Data monitoring committees (DMCs), or data and safety monitoring boards, protect clinical trial participants by conducting benefit-risk assessments during the course of a clinical trial. These evaluations may be improved by broader access to data and more effective analyses and presentation. Data monitoring committees should have access to all data, including efficacy data, at each interim review. The DMC reports should include graphical presentations that summarize benefits and harms in efficient ways. Benefit-risk assessments should include summaries that are consistent with the intention-to-treat principle and have a pragmatic focus. This article provides examples of graphical summaries that integrate benefits and harms, and proposes that such summaries become standard in DMC reports.

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Published In

Ann Intern Med

DOI

EISSN

1539-3704

Publication Date

January 21, 2020

Volume

172

Issue

2

Start / End Page

119 / 125

Location

United States

Related Subject Headings

  • Risk Assessment
  • Quality Improvement
  • Humans
  • General & Internal Medicine
  • Decision Making
  • Data Interpretation, Statistical
  • Clinical Trials Data Monitoring Committees
  • Access to Information
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences
 

Citation

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ICMJE
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Evans, S. R., Bigelow, R., Chuang-Stein, C., Ellenberg, S. S., Gallo, P., He, W., … Rockhold, F. (2020). Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job. Ann Intern Med, 172(2), 119–125. https://doi.org/10.7326/M19-1491
Evans, Scott R., Robert Bigelow, Christy Chuang-Stein, Susan S. Ellenberg, Paul Gallo, Weili He, Qi Jiang, and Frank Rockhold. “Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job.Ann Intern Med 172, no. 2 (January 21, 2020): 119–25. https://doi.org/10.7326/M19-1491.
Evans SR, Bigelow R, Chuang-Stein C, Ellenberg SS, Gallo P, He W, et al. Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job. Ann Intern Med. 2020 Jan 21;172(2):119–25.
Evans, Scott R., et al. “Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job.Ann Intern Med, vol. 172, no. 2, Jan. 2020, pp. 119–25. Pubmed, doi:10.7326/M19-1491.
Evans SR, Bigelow R, Chuang-Stein C, Ellenberg SS, Gallo P, He W, Jiang Q, Rockhold F. Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job. Ann Intern Med. 2020 Jan 21;172(2):119–125.

Published In

Ann Intern Med

DOI

EISSN

1539-3704

Publication Date

January 21, 2020

Volume

172

Issue

2

Start / End Page

119 / 125

Location

United States

Related Subject Headings

  • Risk Assessment
  • Quality Improvement
  • Humans
  • General & Internal Medicine
  • Decision Making
  • Data Interpretation, Statistical
  • Clinical Trials Data Monitoring Committees
  • Access to Information
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences