Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative
Open accessAbstract
Background/aims: Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative—a public–private partnership to improve clinical trials—launched a multi-stakeholder project. Methods: The data monitoring committee project team included 16 individuals charged with (1) clarifying the purpose of data monitoring committees, (2) identifying best practices for independent data monitoring committee conduct, (3) describing effective communication practices, and (4) developing strategies for training data monitoring committee members. Evidence gathering included a survey, a series of focus group discussions, and a 2-day expert meeting aimed at achieving consensus opinions that form the foundation of our data monitoring committee recommendations. Results: We define the role of the data monitoring committee as an advisor to the research sponsor on whether to continue, modify, or terminate a trial based on periodic assessment of trial data. Data monitoring committees should remain independent from the sponsor and be composed of members with no relevant conflicts of interest. Representation on a data monitoring committee generally should include at least one clinician with expertise in the therapeutic area being studied, a biostatistician, and a designated chairperson who has experience with clinical trials and data monitoring. Data monitoring committee meetings are held periodically to evaluate the unmasked data from ongoing trials, but the content and conduct of meetings may vary depending on specific goals or topics for deliberation. To guide data monitoring committee conduct and communication plans, a charter consistent with the protocol’s research design and statistical analysis plan should be developed and agreed upon by the sponsor and the data monitoring committee prior to patient enrollment. We recommend concise and flexible charters that explain roles, responsibilities, operational issues, and how data monitoring committee recommendations are generated and communicated. The demand for data monitoring committee members appears to exceed the current pool of qualified individuals. To prepare a new generation of trained data monitoring committee members, we encourage a combination of didactic educational programs, practical experience, and skill development through apprenticeships and mentoring by experienced data monitoring committee members. Conclusion: Our recommendations address data monitoring committee use, conduct, communication practices, and member preparation and training. Furthermore recommendations form the foundation for ongoing efforts to improve clinical trial oversight and enhance the safety and integrity of clinical research. These recommendations serve as a call to action for implementation of best practices that benefit study participants, study sponsors, and society.
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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 [452]
Independence, particularly from the sponsor and trial investigators, is a key characteristic of the data monitoring committee.
“Independence, particularly from the sponsor and trial investigators, is a key characteristic of the data monitoring committee and can be broadly defined as the committee comprising members who are “completely uninvolved in the running of the trial and who cannot be unfairly influenced (either directly or indirectly) by people, or institutions, involved in the trial.”363 452”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [452]
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“In addition, the charter should clearly describe the decision-making process of the DMC, describe how DMC recommendations are made, and include the following items: (1) composition, including the number and expertise areas of its members; (2) scheduled data transfers from the trial’s data management group to the Stati…”
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InfluentialData and Safety Monitoring Board Best Practices in Clinical Trials
Klein, G. L., Morgan, R. E., Palmer, M., Lazar, J., Byrth, F., Dankner, W. M., Chang, J., Hinkle, J. E., & Sergi, J. (2026) · Cureus · doi:10.7759/cureus.107661
- Authors
- Calis, K. A., Archdeacon, P., Bain, R., DeMets, D., Donohue, M., Elzarrad, M. K., Forrest, A., McEachern, J., Pencina, M. J., Perlmutter, J., & Lewis, R. J.
- Affiliations
- National Institutes of Health (US)
- United States Food and Drug Administration (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- University of Wisconsin–Madison (US)
- IQVIA (United States) (US)
- Clinical Trials Transformation Initiative, Durham, NC, USA
- PAREXEL International (United States) (US)
- Duke Clinical Research Institute (US)
- Ann Arbor, MI, USA
- Harbor–UCLA Medical Center (US)
- Corresponding author
- Forrest, Annemarie
- ORCID
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2017-05-13
- Volume
- 14
- Issue
- 4
- Pages
- 342-348
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- PMC
- PMC5639979
- OpenAlex
- W2613905750
- Cited by
- 58
- References
- 4
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 8 · 2023: 6 · 2022: 8 · 2021: 8 · 2020: 7 · 2019: 5 · 2018: 6 · 2017: 3
- FWCI
- 3.99
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Clinical Trials (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc)
- Funders
- U.S. Food and Drug Administration (R18FD005292, U19FD003800)
- 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, clinical trial oversight, independent review, conflicts of interest, best practices
- MeSH terms
- Clinical Trials as Topic, Data Interpretation, Statistical, Humans, Research Design, Clinical Trials Data Monitoring Committees, Consensus, Interdisciplinary Communication, Quality Improvement
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