Live Case Presentations During Investigational Device Clinical Trials
This guidance provides recommendations for IRBs, industry, clinical investigators, and FDA staff regarding live case presentations during IDE clinical trials. A live case presentation is defined as a live or pre-recorded broadcast of a surgical or percutaneous procedure, typically narrated by the operator or discussant, with potential expert panel/audience interaction. The guidance aims to ensure adequate human subject protection, follow-up, reporting, and data analysis for live case presentations.
Recommended Actions
- Evaluate if live case presentations are appropriate for your clinical investigation early in development
- Include comprehensive risk analysis addressing all additional risks in IDE application
- Develop specific informed consent documents for live case presentations
- Implement measures to minimize risks:
- Use separate discussant/narrator
- Record procedures when possible
- Select appropriate subjects
- Ensure proper sterile environment
- Establish data collection and reporting procedures:
- Separate analysis of live case subjects
- Detailed documentation of any protocol deviations
- Comprehensive adverse event reporting
- Submit IDE supplement at least 30 days prior to planned presentation
- Obtain both FDA and IRB approval before conducting live case presentations
- Include live case presentation outcomes in annual progress reports and final study report
- Consider impact on study design and statistical analysis plan
- Implement additional safeguards if children are involved
Key Considerations
Clinical testing
- Live case presentations should be conducted only at approved investigational sites by investigators participating in the study
- Clinical outcomes should be analyzed separately and compared to the remaining investigational cohort
- Additional follow-up may be warranted for live case subjects
- Data collection should be no less rigorous than for the general investigational cohort
Human Factors
- A discussant/narrator other than the operating surgeon should participate to reduce risks
- Increased pressure on operator due to public scrutiny should be considered
- Potential distraction of medical personnel should be addressed
Labelling
- Informed consent must include specific information about the live case presentation
- Additional risks and privacy concerns must be clearly described
- No additional direct benefits should be claimed
Safety
- Risk analysis must address increased infection risks due to additional personnel/equipment
- Prolonged procedure time risks must be evaluated
- Additional risks for children must be carefully considered
- Safety measures to minimize risks must be implemented
Other considerations
- Live case presentations are not appropriate for Expanded Access use
- Selection bias must be addressed in study design
- Impact on study blinding must be considered
- Proper reporting of adverse events during live cases is required
- Privacy and confidentiality measures must be implemented
Relevant Guidances
- Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
- IDE Clinical Investigation Decision Process and Requirements
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
Related references and norms
- 21 CFR part 50: Protection of Human Subjects
- 21 CFR part 56: Institutional Review Boards
- 21 CFR part 812: Investigational Device Exemptions
Original guidance
- Live Case Presentations During Investigational Device Clinical Trials
- HTML / PDF
- Issue date: 2019-07-11
- Last changed date: 2024-04-11
- Status: FINAL
- Official FDA topics: Medical Devices, Pediatric Product Development, Good Clinical Practice (GCP), Premarket, Investigational Device Exemption (IDE)
- ReguVirta summary file ID: 2147a0ca2f860e256370b56d3e1dd6b0
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