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.
