Independent data monitoring committees: rationale, operations and controversies
Abstract
Data monitoring committees (DMCs) have become an increasingly common component of randomized clinical trials in recent years. As experience has accumulated, and more individuals and organizations have become involved in such activities, a variety of approaches to the operation of such committees has inevitably arisen. Because these committees play such a critical role in the process of new drug development, it is important to consider the implications of the different approaches that are being used. It is also timely to consider the present and possible future regulatory status of data monitoring committees. Published in 2001 by John Wiley & Sons, Ltd.
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A data monitoring committee will often comprise members from a variety of disciplines.
“A data monitoring committee will often comprise members from a variety of disciplines.363 451 452”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [451]
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References 26 · Cited by 28
- Authors
- Ellenberg, S. S.
- Affiliations
- Center for Biologics Evaluation and Research (US)
- Corresponding author
- Ellenberg, Susan S.
- ORCID
- Ellenberg, Susan S.
- Venue
- Statistics in Medicine
- Publisher
- Wiley
- Published
- 2001-08-14
- Volume
- 20
- Issue
- 17-18
- Pages
- 2573-2583
- ISSN
- 0277-6715 (ISSN-L)
- 1097-0258
- OpenAlex
- W1987475043
- Cited by
- 28
- References
- 26
- Citations by year
- 2025: 1 · 2023: 2 · 2022: 1 · 2021: 1 · 2019: 1 · 2018: 1 · 2017: 2 · 2013: 4 · 2012: 1
- FWCI
- 2.66
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Statistics in Medicine (publishedVersion, public-domain)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- data monitoring committees, randomized controlled trials, drug development, regulatory status, committee activities, independent oversight, clinical trial ethics
- MeSH terms
- Clinical Trials as Topic, Drug Evaluation, Humans, Research Design
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