Box 5.5

What to do if safety concerns lead to an unexpected trial closure


Click here to download a checklist that summarizes what should happen if the management decides to stop a trial after a recommendation by the DSMB to suspend the trial for safety reasons. In multicenter trials or those that have international sponsors, some of these actions may be coordinated and implemented centrally. It is important to establish a clear division of labor for those who will alert the various stakeholders listed below. Prompt and open communication with all stakeholders is essential in such situations.