Data monitoring committee
Data Monitoring Committee
The Data Monitoring Committee (DMC), also known as a Data and Safety Monitoring Board (DSMB), is a group of independent experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
Pronunciation: /ˈdeɪtə ˈmɒnɪtərɪŋ kəˈmɪti/
Etymology: The term is derived from the English words "data" (facts and statistics collected for reference or analysis), "monitoring" (observe and check the progress or quality of something over a period of time), and "committee" (a group of people appointed for a specific function by a larger group).
Role and Responsibilities
The DMC's primary responsibility is to ensure the safety of trial participants and the validity and integrity of data in a clinical trial. They review interim analysis of data and make recommendations on whether the trial should continue, be modified, or stopped for safety or efficacy reasons.
Composition
A DMC typically includes experts in clinical trial methodology, statisticians, and clinicians knowledgeable about the disease and treatment under study. It may also include bioethicists and patient representatives.
Related Terms
- Clinical trial: A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
- Interim analysis: An analysis of data that is conducted before data collection has been completed.
- Statisticians: Professionals who use statistical methods to collect and analyze data and help solve real-world problems in business, engineering, healthcare, or other fields.
- Clinicians: Health care professionals who work as a primary care giver of patients in a health care setting.
- Bioethicists: Professionals who study the philosophical, ethical, and legal issues arising in medicine and the life sciences.
External links
- Medical encyclopedia article on Data monitoring committee
- Wikipedia's article - Data monitoring committee
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