Live Case Presentations

OMEDtechNews & Events

The FDA has released a draft guidance covering live case presentations during investigational device exemption (IDE) clinical trials.  This draft guidance provides insight as to what should be provided in an IDE application regarding a live case presentation.  A live case presentation is  “the treatment of a human subject under the auspices of an approved or conditionally approved IDE, conducted and broadcast in real time, or recorded for broadcast at a later time.” (FDA)  While a live case presentation is not necessary for most IDEs, it may increase overall awareness for the study, which could increase the possibility of making new therapies available to the public in a faster time frame. Live case presentations are not appropriate for all IDE studies, including high risk procedures, certain pediatric studies, or novel devices where the risk is unknown. Since broadcasts of these presentations may be considered promotional in nature, sponsors should provide reasoning why the live case presentation would not be in violation of prohibited practices. The IDE should list all possible risks and explain how the risks will be minimized. If any adverse device effects occur during a live case presentation they should be reported as soon as possible. If a live case presentation was approved but not performed a report should be filed with the FDA. The FDA will review data from the live case presentation for safety and effectiveness and to determine if the data is used to support a marketing submission. The FDA hopes to improve their feedback of human subject protection, follow-up, reporting, and data analysis for live case presentations by shifting its evaluation to a single review when the original IDE application is submitted.“By proactively anticipating the need for live case presentations, and prospectively identifying the study parameters around such live case presentations, the FDA 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.” (FDA)