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 ?
These studies (and there are several types of Phase IV/Post Marketing studies) answer important safety questions and because of this and the duration of these studies, they are almost always associated with Data Monitoring Committees (DMC).
com) announces a new, standards-based platform for independent Data Monitoring Committees.
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.
the leading provider of adaptive clinical trial services and biostatistical software, announced an webinar that examines the increasing use of Data Monitoring Committees (DMC or DSMB) for monitoring safety or for interim analyses and adaptive changes.
About ACI Clinical ACI Clinical is a specialty group that manages Endpoint Adjudication Committees and Data Monitoring Committees, with related Data and Advisory services, in order to enhance trial integrity and prepare data for publication, submission, and approval.
Data Monitoring Committees (DMCs) / Data Safety Monitoring Boards (DSMBs)
st] 2014, to better reflect the organization's services related to Endpoint Adjudication Committees (EAC) and Data Monitoring Committees (DMC) in clinical research.
The company also provides clinical trial design and clinical events committee support services, and serves as the independent statistical center for Data Monitoring Committees.
March 28, 2011 /PRNewswire/ -- Applied Clinical Intelligence, LLC (ACI), an industry leader in clinical endpoint adjudication committees and independent data monitoring committees (www.
Independent providers are able to collect, consider, and analyze data apart from those sponsoring, organizing, and conducting trials or marketing the new products -- a primary intent of the new laws -- through patient and study outcome registries as well as data and safety monitoring boards or data monitoring committees.
ACI provides data-driven solutions for clinical trials and risk management programs; offering Data Monitoring Committees Services, ISS/ISE, CIDSC Dataset conversion, Cardiac Safety, Project Rescue, Longitudinal Data Integration as well as Traditional CRO Services.
Services include Program Planning, Study Design, Clinical Monitoring, Medical Monitoring, Data Management, Database Development, Biometrics, Medical Writing, Data Monitoring Committees, Compliance and Validation, and FDA Representation.