data monitoring committee

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data monitoring committee

A group of experts who regularly review accumulating data from an ongoing clinical trial, advising the sponsor about safety of current (and future, if applicable) participants, and continuing validity and scientific merit of the trial. The committee can stop a trial if it finds toxicities in excess of that expected, or if the treatment is so clearly beneficial that FDA approval of the drug would be inevitable.
References in periodicals archive ?
The use of independent data monitoring committees is becoming increasingly prevalent in the U.S.
"Judi provides a purpose-built solution for endpoint adjudication that enables efficient database set-up and data extraction, and manages workflow effectively," said Craig McLendon, senior director, Adjudication and Data Monitoring Committees Management, ICON.
The topics include basic ideas in clinical trial design, regression and analysis of covariance, non-parametric and related methods, interim analysis and data monitoring committees, and methods for analyzing and monitoring safety.
According to the Food and Drug Administration (FDA) Guidance for Clinical Trial Sponsors--Establishment and Operation of Clinical Trial Data Monitoring Committees (DMC) [1], 'A clinical trial DMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials'.
Role of statisticians and the interim analyses they conduct in data monitoring committees
Larix, a full-service clinical research organization in Denmark, provides services within statistics, data management, clinical research, pharmacovigilance and data monitoring committees to pharmaceutical, biotechnology and medical device companies.
"It charges IRBs [institutional review boards] with functions that they cannot credibly perform." The authors also criticize the adversarial yet symbiotic relationships between IRBs and data monitoring committees, which sometimes are used to independently assess a study and protect test subjects, thereby putting them in the position of both acting as watchdog and working to keep a study on track.
* professional, financial, and ethical conflicts among study sponsors, institutional review boards (IRBs), data monitoring committees, researchers, and test subjects;