A Data Monitoring Committee (DMC) is an independent body that evaluates accumulating clinical trial data, monitors patient safety and efficacy and ensures the trial’s validity and integrity.
In response to the growing demand for qualified and skilled individuals to serve on trial sponsor-independent DMCs, the TransCelerate DMC Initiative developed a concept for a DMC Registry that could serve as a central repository of information for individuals who wish to take on this role. As proposed by TransCelerate, this registry would be a publicly available resource that collects relevant data on interested clinical research professionals, whether they have previously served as a DMC member or are interested in doing so, but lack prior DMC experience.
Additionally, the DMC Initiative developed an apprenticeship model concept, which could further enhance the effectiveness of a DMC by offering an avenue for upskilling its members. The proposed concept focuses on sponsors fostering mentor/apprentice pairs.
The resources below provide additional detail as to what these concepts could look like, should a functioning registry be developed.
What is the DMC Registry Concept?
Demonstrates the purpose and functionality of the proposed DMC Registry.
Provides a high-level overview of the proposed apprenticeship model. The Apprenticeship Model intends to expose clinical research professionals with little or no prior DMC experience, who are interested in serving on a DMC, to the interim data monitoring process firsthand and the chance to discuss this experience and the questions arising from it with a more experienced DMC member.