A Data Monitoring Committee (DMC), also known as a Data and Safety Monitoring Board (DSMB), is an independent group of clinical and statistical experts that monitors patient safety and treatment efficacy data whilst the clinical trial is ongoing.
Having a DMC can help the sponsor stop the study early for a favorable or unfavorable result, at prespecified interim analyses timepoints. A DMC can also provide monitoring for safety concerns, and decide to drop arms or stop the study, to ensure patient safety.
Therefore, including a DMC in a study can be beneficial both for the Sponsor and Patients, both accelerating the decision making, and protecting patients from harm.
What to expect
- Help you create or review the DMC charter
- Program and QC tables, listings, and figures (TLFs) deliverables to the DMC
- Analyse and interpret data for efficacy, safety, study conduct, and interim analyses
- Prepare and present reports for open and closed-session meetings
- Draft meeting minutes for the close-session meetings
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