November 11, 2016: Recommendations from the Clinical Trials Transformation Initiative’s Data Monitoring Committee Project
Karim Anton Calis, PharmD, MPH, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Ray Bain, PhD, Biostatistics and Research Decision Sciences, Merck Research Laboratories
Dave DeMets, PhD, Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison
Recommendations from the Clinical Trials Transformation Initiative’s Data Monitoring Committee Project
Data and safety monitoring; Data monitoring committee; DMC; Research oversight; Biostatistics; Clinical informatics; Clinical Trials Transformation Initiative; CTTI
- Randomized clinical trials are increasingly overseen by independent data monitoring committees (DMCs) that monitor trial conduct and safety and make recommendations for trial changes. A DMC is a group of individuals who review accumulating trial data by treatment group in order to monitor patient safety and efficacy, ensure the validity and integrity of the trial, and make a benefit-risk assessment.
- Responsibilities of DMCs can include reviewing data quality, trial operations, and ethical oversight. The evolving roles of DMCs, however, have led to unclear expectations among DMCs and other stakeholders including sponsors, contract research organizations, regulators, investigators, and patients.
- The Clinical Trials Transformation Initiative (CTTI) established the Data Monitoring Committees project team to study the roles and responsibilities of DMCs and to develop recommendations on their composition, communication among members and other stakeholders, establishing a charter, and issues related to DMC training.
- CTTI recommends that DMC members be independent of the trial sponsor and be provided with adequate resources and flexibility to perform their role of assessing benefit-risk (e.g., performing ad hoc analyses as needed, having full access to accumulating unmasked study data).
- Roles, responsibilities, and operational issues should be clearly outlined in a succinct, well-organized charter that empowers the DMC and allows flexibility in operations and recommendations while ensuring that the perspectives of sponsor and investigators are appropriately represented.
Independence and transparency are critical to the optimal functioning of DMCs. Use of a DMC can enhance the credibility of trials among both patients and clinicians.
To better understand the complexities of DMCs, researchers should consider participating in an external, active DMC.
Are there unique challenges in monitoring pragmatic clinical trials?
What additional actions can CTTI take to facilitate adoption of these recommendations?
For More Information
To read more about and download CTTI’s recommendations for data monitoring committees, visit http://bit.ly/2fFIrla.
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