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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Evans, SR; Bigelow, R; Chuang-Stein, C; Ellenberg, SS; Gallo, P; He, W; Jiang, Q; Rockhold, F

Published Date

  • January 21, 2020

Published In

Volume / Issue

  • 172 / 2

Start / End Page

  • 119 - 125

PubMed ID

  • 31739312

Pubmed Central ID

  • 31739312

Electronic International Standard Serial Number (EISSN)

  • 1539-3704

Digital Object Identifier (DOI)

  • 10.7326/M19-1491

Language

  • eng

Conference Location

  • United States