Scott R. Evans, PhD; Robert Bigelow, PhD; Christy Chuang-Stein, PhD; Susan S. Ellenberg, PhD; Paul Gallo, PhD; Weili He, PhD; Qi Jiang, PhD; Frank Rockhold, PhD
Disclaimer: The views expressed here are solely those of the authors and do not necessarily reflect the positions, policies, or practices of the authors' employers.
Acknowledgment: The authors thank the Quantitative Sciences in the Pharmaceutical Industry and the Society for Clinical Trials for their support of this project.
Financial Support: The authors did not receive any specific funding for this work but acknowledge that they were employed by their respective affiliations while this work was conducted.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-1491.
Corresponding Author: Scott R. Evans, PhD, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, 6110 Executive Boulevard, Suite 750, Rockville, MD 20852; e-mail, sevans@bsc.gwu.edu.
Current Author Addresses: Dr. Evans: Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, 6110 Executive Boulevard, Suite 750, Rockville, MD 20852.
Dr. Bigelow: Duke Clinical Research Institute, 200 Morris Street, Durham, NC 27703.
Dr. Chuang-Stein: Chuang-Stein Consulting, 5857 Stoney Brook Road, Kalamazoo, MI 49009.
Dr. Ellenberg: Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Blockley 611, Philadelphia PA 19104.
Dr. Gallo: Statistical Methodology and Consulting, Novartis Pharmaceuticals, One Health Plaza, East Hanover, NJ 07936.
Dr. He: AbbVie, DSS – Statistical Sciences, R436, Building AP9A LL, 1 North Waukegan Road, North Chicago, IL 60064.
Dr. Jiang: Biometrics, Seattle Genetics, 21823 – 30th Drive Southeast, Bothell, WA 98021.
Dr. Rockhold: Duke Clinical Research Institute, Duke University Medical Center, P.O. Box 17969, Durham, NC 27715.
Author Contributions: Conception and design: S.R. Evans, R. Bigelow, C. Chuang-Stein, P. Gallo, F. Rockhold.
Analysis and interpretation of the data: S.S. Ellenberg, W. He, Q. Jiang, F. Rockhold.
Drafting of the article: S.R. Evans, R. Bigelow, C. Chuang-Stein, S.S. Ellenberg, P. Gallo, Q. Jiang, F. Rockhold.
Critical revision for important intellectual content: S.R. Evans, R. Bigelow, S.S. Ellenberg, W. He, F. Rockhold.
Final approval of the article: S.R. Evans, R. Bigelow, C. Chuang-Stein, S.S. Ellenberg, P. Gallo, W. He, Q. Jiang, F. Rockhold.
Statistical expertise: S.R. Evans, R. Bigelow, C. Chuang-Stein, S.S. Ellenberg, W. He, Q. Jiang, F. Rockhold.
Administrative, technical, or logistic support: C. Chuang-Stein, W. He.
Collection and assembly of data: W. He.
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.
Evans SR, Bigelow R, Chuang-Stein C, et al. Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job. Ann Intern Med. 2019;:. [Epub ahead of print 19 November 2019]. doi: https://doi.org/10.7326/M19-1491
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© 2019
Published: Ann Intern Med. 2019.
DOI: 10.7326/M19-1491
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