FDA is calling for an international consortium of cardiovascular registries to coordinate data from multiple disease registries for use in testing the efficacy and safety of medical devices per a recent article on RAPS.org. Patient registries have been used in the past to help regulators manage data from common diseases, as well as gather information to help guide clinical trial expectations. FDA’s international cardiovascular consortium model is based on the International Consortium of Orthopedic Registries (ICOR), which also links various member registries. According to FDA, the registry would serve to “allow for broad-based analysis and surveillance of medical device exposure and related clinical outcomes.” FDA is planning to hold a workshop to gain public input on the proposal and discuss how to implement the plan. To read the full article on RAPS.org, click here.
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