FDA issues draft guidance on live case presentations; implications for human subject protections

The Food and Drug Administration has issued new draft guidance on live case presentations, treatments of study participants under the auspices of an investigational device exemption (IDE) either conducted and broadcast in real time, or recorded for later broadcast.  In these presentations, the physician conducting a procedure often narrates and/or interacts with an audience or expert panel during the procedure.  The Agency has seen an increase in requests for live case presentations (“LCPs”) in IDE studies, and notes that LCPs may increase study visibility leading to accelerated recruitment and enrollment.  Accelerated enrollment may, in turn, lead to earlier availability of new therapies. 

The draft guidance addresses human subject protections for participants involved in LCPs.  Research involving LCPs must still meet all of the criteria for IRB approval of research, including requirements that risks to participants are minimized, informed consent is sought in accordance with regulatory requirements and adequate provisions for participant privacy and data confidentiality are in place.  Additional requirements for research involving children may also be applicable.  Study participants involved in an LCP should have the same expectation of benefit as other participants, but there is a concern that LCPs may present increased risk to the participant based upon factors such as longer procedure times (to account for recording/broadcast issues or narration of steps), distraction of the physician, increased infection risk due to additional non-medical personnel and broadcast equipment in the procedure area, invasion of participant privacy and potential compromise of data confidentiality.  The Agency’s preference is that a narrator is present to explain the procedure and address questions to reduce distraction of the physician performing the procedure, but this may not be required in all cases.  The investigational plan’s risk analysis should identify the risks and benefits of a LCP, and discuss how the risks will be minimized.     

Participants should be able to enroll in a study without consenting to an LCP and it should be made clear to them that their involvement in an LCP is optional and will not result in preferential treatment from the investigator.  Separate informed consent for a study participant’s involvement in an LCP is required, and the consent form should minimally include reference to: the recording/future broadcast of the procedure; the lack of additional direct benefits for participants in an LCP; additional risks presented by participation in an LCP; and additional concerns related to privacy and confidentiality for participants involved in an LCP.      

The IRB must review and approve the proposed conduct of a LCP and accompanying consent procedures/documentation in advance of the procedure for both significant risk and non-significant risk studies.  Note that additional risks involved in an LCP may change a study’s risk level from non-significant to significant risk.   

The draft guidance also references additional content for applicants to include in their IDE submissions and investigational plans when an LCP is planned: issues of unblinding and alterations to the randomization schedule should be discussed; there should be no less data collected for LCPs than for the general study population; and clinical outcomes of participants involved in LCPs should be collected and analyzed separately.  The draft guidance reflects the Agency’s preference that LCPs be included in the protocol submitted with an original IDE application (as opposed to submission in an IDE supplement) because prospective review of the planned LCP at a study’s outset is anticipated to improve FDA feedback on human subject protections and data analysis for the impacted subset of the study population.  FDA will also review the applicant’s rationale for conducting an LCP to ensure that prohibitions against promotion of investigational devices are not violated.  Included with the draft guidance is a checklist of items to consider in an original or supplement IDE application when requesting inclusion of an LCP.  Sections of the checklist include general information, informed consent, reporting and analysis plans, IRB review and additional safeguards for children.   

Finally, the guidance notes that not all IDE studies are conducive to LCPs, especially those involving high risk procedures, pediatric populations or novel devices with an uncertain risk profile.  The Agency also believes that LCPs are inappropriate under the IDE Continued Access program and under the Compassionate Use Program.      

Comments on the draft guidance must be submitted by July 16, 2014.

Please contact a member of the This email address is being protected from spambots. You need JavaScript enabled to view it. to learn more or to request a copy of the draft guidance. 

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