Dear Friends,

The FDA recommended both Data Safety Monitoring Boards (DSMB) and Clinical Events Committees (CEC) be used for clinical trials examining replacement heart valves, in a draft guidance  issued Jan. 20. Click here for the Draft Guidance

The DSMB should establish criteria for recommending study termination for safety reasons before the study begins and should meet at least twice during the study to monitor adverse events, the agency recommended. The FDA said the DSMB should have members who are independent of the study sponsors and investigators and that two or more members should be physicians, including a cardiothoracic surgeon and a cardiologist. In addition, if the study includes statistical analyses, one DSMB member should be a statistician.

The Clinical Events Committee would adjudicate whether adverse events are valve-related and classify the severity of adverse events. Its members also should be independent of the study sponsors and investigators.

The guidance recommended that all study subjects be followed for at least one year. “If your clinical investigation is for one valve position, we recommend that you follow 300 or more subjects for one year or more for a total of 800 patient-years of follow-up.” If the study is for two valve positions, the agency recommended following 150 subjects for one year or more for each valve position for a total of 400 patient-years of follow-up per valve position.

The guidance said that “follow-up data should be collected for each subject until the entire study is terminated for all subjects.” The agency noted that as this follow-up period may be “significantly” longer than what is stated in the study protocol, and that the investigator must receive informed consent to such follow-up periods from all subjects.

Kind regards,