The U.S. Food and Drug Administration (FDA) issued final guidance Wednesday on live case presentations made during investigational device exemption (IDE) clinical trials.
The guidance says that institutional review boards (IRBs) should consider the following approval criteria when evaluating a request for a live case representation as part of an IDE trial: that risks to human subjects are minimized, informed consent is sought, and adequate provisions are made to protect the privacy of subjects and maintain the confidentiality of data. These criteria are based on Title 21 of the Code of Federal Regulations.
The document adds that IRBs should review proposals for IDE trial live case presentations “with particular concern for additional risks to the safety of the children during the procedure.”
The guidance says that the sponsor of an IDE trial “involving a significant risk device … must obtain FDA approval of changes to the investigational plan … prior to conducting a live case presentation.” It adds that for “non-significant risk devices, sponsors must obtain IRB approval … prior to changing the investigation to include a live case presentation.”
When possible, the FDA says, approval of live case presentations as part of IDE trials should be included in the application for the trial itself. However, the agency acknowledged that trial designs often do not anticipate live case presentations.
“By proactively anticipating live case presentations and prospectively identifying the study parameters around such live case presentations, the Agency believes that protections to human research subjects will be improved, burdens to the sponsor and the Agency will be minimized, and study validity related to live case presentations using investigational devices will be assured,” the FDA’s guidance says.
A draft of the guidance was issued in April 2014.