EMA Publishes Nine Q&As Discussing New DMC Guidelines
A new guideline from the European Medicines Agency (EMA) provides recommendations on how data monitoring committees (DMC) should proceed when considering stopping a trial.
The recommendations in the question-and-answer supplement to the EMA’s existing DMC guidelines are not binding for the trial sponsor but the agency suggests that sponsors should notify the ethics committee and regulatory bodies if they don’t plan to follow DMC recommendations to stop or significantly modify their trial.
According to the EMA, both the DMC and the sponsor’s representative(s) should make efforts “to reconcile their opposing views” about stopping a trial. If this reconciliation isn’t possible, a closed session with the DMC, senior sponsor staff and external experts should be convened to reach a consensus.
Read the full EMA document here: https://bit.ly/2GNoj3k.