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