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Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job
- Source :
- Annals of internal medicine. 172(2)
- Publication Year :
- 2019
-
Abstract
- 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.
- Subjects :
- Research design
Process management
Quality management
media_common.quotation_subject
Decision Making
MEDLINE
01 natural sciences
Risk Assessment
Access to Information
03 medical and health sciences
Presentation
0302 clinical medicine
Interim
Internal Medicine
Medicine
Data monitoring committee
Humans
030212 general & internal medicine
0101 mathematics
media_common
business.industry
010102 general mathematics
General Medicine
Quality Improvement
Clinical trial
Data access
Data Interpretation, Statistical
business
Clinical Trials Data Monitoring Committees
Subjects
Details
- ISSN :
- 15393704
- Volume :
- 172
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Annals of internal medicine
- Accession number :
- edsair.doi.dedup.....d9c8470aaebb66360689b334b084b367