September 8, 2022
Advancing Prospective Cardiovascular Device Clinical Trials Science: Optimizing Ethical Expertise & Efficiency Metrics Through Centralized IRBs
12:30 – 6:00 pm ET
Co-planned with MDEpiNet and CTTI.
- To examine the scientific and ethical rationale of centralized IRBs for prospective multicenter trials of cardiovascular devices
- To develop key metrics of prospective device trials quality, efficiency, cost and value associated with the use/re-use of centralized IRB processes for CV devices
- To explore the role and operational integration of professional society CV device registries in partnering/facilitating centralized IRB processes/efficiencies in conjunction with registry-supported prospective CV device studies
- To explore the potential facilitation of CV device innovation by leveraging centralized IRB infrastructure to provide re-usable repositories of experience and knowledge in areas of unmet clinical need where research includes challenging, nuanced aspects of ethical oversight such as optimizing approaches to informed consent.