All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data. Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices. Depending on the nature of the test agent, the vulnerability of the study population, the length of the study, or the number of sites conducting the clinical study. The "Plan" increasingly has the "Charter" of what is called a Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB).
DMC's and their composition play an increasingly important roll in both multi-center studies and where there are expected or possible adverse events. With the increasing globalization of IMP development and increasing complexity of new agents, the FDA has increasingly recommended and sometimes mandated that a DMC be involved to advise the sponsor regarding subject safety. The "Stopping Rules" are an important element in a DMC function. The overriding reason for a carefully selected (no Conflict of Interest) Independent DMC is to promote and guarantee human subject safety as well as data integrity.
It is important to see what the FDA regulations and the ICH GCP recommendations are in regard to DMC's. Most importantly, when does an adverse event (AE) or string of AE's lead to changes in a study protocol or even discontinuation of a study.
Why should you attend: With the increasing requirements for a DMC oversight it behooves all involved to know the set-up and function of these committees. Forewarned is forearmed.
Areas Covered in the Session: