Data monitoring committee

From WikiMD's Wellness Encyclopedia

(Redirected from Data Monitoring Committee)

Data Monitoring Committee (DMC), also known as 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.

Role and Responsibilities[edit | edit source]

The primary role of a DMC is to ensure the safety of trial participants and the validity and integrity of data in a clinical trial. The DMC has the authority to recommend continuation, modification, or termination of a trial based on the observed beneficial or adverse effects of the treatment under study.

The responsibilities of a DMC include:

  • Reviewing the clinical trial protocol and plans for data analysis.
  • Monitoring the rate of enrollment, dropout, and missing data.
  • Evaluating the quality of data collected.
  • Monitoring the overall conduct of the trial.
  • Reviewing accumulated data from the trial and deciding whether it is ethical to continue, modify, or stop the trial.

Composition[edit | edit source]

A DMC typically consists of clinical trial experts, statisticians, and clinicians knowledgeable about the disease and treatment under study. It may also include bioethicists and patient representatives. The members should have no financial, scientific, or other conflict of interest with the trial.

Meetings[edit | edit source]

DMC meetings are usually held in private, and the frequency of meetings depends on the type of trial, the rate of enrollment, and the rate of occurrence of endpoints. The DMC reviews reports prepared by a statistical data analysis center, which is separate from the trial investigators and sponsor.

Confidentiality[edit | edit source]

The DMC has access to unblinded trial data, which must be kept confidential to maintain the integrity of the trial. The DMC's recommendations are usually communicated to the trial sponsor and investigators through a formal letter.

See Also[edit | edit source]

Data monitoring committee Resources
Wikipedia
WikiMD
Navigation: Wellness - Encyclopedia - Health topics - Disease Index‏‎ - Drugs - World Directory - Gray's Anatomy - Keto diet - Recipes

Search WikiMD

Ad.Tired of being Overweight? Try W8MD's physician weight loss program.
Semaglutide (Ozempic / Wegovy and Tirzepatide (Mounjaro / Zepbound) available.
Advertise on WikiMD

WikiMD's Wellness Encyclopedia

Let Food Be Thy Medicine
Medicine Thy Food - Hippocrates

WikiMD is not a substitute for professional medical advice. See full disclaimer.
Credits:Most images are courtesy of Wikimedia commons, and templates Wikipedia, licensed under CC BY SA or similar.

Contributors: Prab R. Tumpati, MD