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.
Reference Type
Journal Article
Periodical Full
Annals of internal medicine
Publication Year
2020
Publication Date
Jan 21,
Volume
172
Issue
2
Start Page
119
Other Pages
125
Publisher
American College of Physicians
Place of Publication
United States
ISSN/ISBN
0003-4819
Document Object Index
10.7326/M19-1491
URL
https://www.ncbi.nlm.nih.gov/pubmed/31739312
PMID
31739312