A data monitoring committee (DMC), also known as a data and safety monitoring board (DSMB), is an independent group of experts who review the safety and efficacy of a clinical trial.
The primary responsibility of a DMC is to ensure that the trial participants are not exposed to unnecessary risks and that the trial data are reliable and accurate. DMCs typically review the accumulating trial data on a regular basis and may make recommendations to the trial sponsor to protect the safety and welfare of trial participants as well as ensure that the trial is conducted in an ethical
and scientifically sound manner.
Roles & Responsibilities:
- DMC charter development & review which outlines the scope of responsibilities and operating procedures.
- Develop statistical analysis plan to specify the analyses and monitor boundaries that will trigger DMC review
- Conduct periodic meetings to review the data, assess safety and efficacy, and make recommendations regarding the continuation, modification, or termination of the trial
- Review and analyze unblinded data, as needed, to provide advice and recommendations to the trial sponsor or steering committee.
- Monitor and assess the performance of the trial investigators, including the accrual rate, data quality, and compliance with the protocol and DSMP.
- Maintain confidentiality of trial data and prepare summary reports of the DMC findings and recommendations for the sponsor, investigators, and regulatory authorities, as required.
