The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and management of clinical trials.
EMA explains that the recommendations of DMCs are not binding for trial sponsors, but that sponsors should justify and document and instances where such recommendations are not followed.
“The ultimate responsibility for a clinical trial rests with the study sponsor, and thus the sponsor must conclude whether or not to follow DMC recommendations,” EMA writes.
However, EMA says that in cases where a DMC recommends stopping or substantially modifying a trial, the sponsor should notify the ethics committee and regulatory authorities if they are not planning to follow the recommendations. EMA notes that DMCs do not have the ability to stop a trial on their own…