On April 17, 2014 the FDA published a draft guidance on Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.
The FDA will take comments regarding this guidance for 90 days or until July 16th, 2014.
A live case presentation is defined as “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.”
Live case presentations use unapproved or uncleared investigational devices. Live case presentations may increase awareness of the study therefore increasing enrollment.
The guidance provides information that should be provided in an IDE application or IDE supplement when a Sponsor anticipates using a live case. It also provides the IRB with guidance when reviewing an investigation that contains a live case presentation.
The FDA’s guidance is only their recommendations and is not the law.
The following include some of FDA’s recommendations:
- Provide rational in the application for why the live case presentation would not be in violation of the prohibited practices, including promotion, test marketing and representing the investigational device as safe and effective
- It should be clearly identified at the beginning of the broadcast that the devices are unapproved and being used as an investigational device
- Explain why a live case presentation is needed
- Must be reviewed and approved by the IRB
- Describe all the potential risks and benefits of the live case presentation
- Increased risk of infection due to increased number of non-medical personnel
- Distraction of the operator; increased pressure of the operator
o Invasion of the subject’s privacy
- A narrator should be present for the procedure. If a narrator isn’t used, this should be discussed with the FDA.
- 2 informed consents must be obtained: 1 for study participation and 1 for the live case presentation.
- The informed consent for the live case presentation should include:
- The procedure will be recorded for future viewing
- No additional direct benefit
- Any additional risks by performing the procedure in this manner
- Any additional issues related to subject confidentiality
- Must be approved by the FDA and IRB for Significant Risk studies
- Additional concerns for use with children
- Follow-up requirements should be reported on in a separate cohort in the annual report to the FDA
- Study monitors should review all live case presentation informed consent documents and subject files to ensure appropriate adherence to the protocol and regulations
- Live case presentations should be submitted to the FDA at least 30 days prior to the planned presentation
- Live case presentations are not appropriate for Continued Access or Compassionate Use studies
The use of live case presentations is important for awareness and enrollment.
Don’t forget to send your comments to the FDA by July 16th.
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