Developing and applying a framework to evaluate and conduct algorithm validation studies for Major Adverse Cardiovascular Events (MACE)

The MACE Project is a multi-sponsored activity that provides stakeholders an opportunity to sponsor and engage in work that will advance the use of RWD for regulatory studies. The MACE Project will evaluate claims-based algorithms for certain high priority clinical endpoints, specifically major adverse cardiovascular events (MACE). MACE are important safety endpoints for a variety of drug classes.

The immediate objective is to develop a novel instrument or tool to evaluate and conduct validation studies of claims-based MACE algorithms in the context of regulatory surveillance and to promote the adoption of the instrument as a standard of practice. The long-term goal is to establish an infrastructure and best practices to systematically evaluate existing algorithms and develop and test new algorithms to represent clinical constructs that are consistently used in regulatory studies. MACE will serve as the initial pilot, from which other AE studies may leverage the framework developed under this pilot.

The development of a tool to evaluate the quality of validation studies may reduce the cost of post-marketing studies by reducing the need for individual sponsor validation studies for each outcome, provide a rigorous framework for future validation studies, and influence the conduct of studies in the FDA’s Sentinel system, and advance the use of real-world data for regulatory decision-making.


To learn more about other projects in the Algorithm Evaluation pipeline and how you can get engaged, please contact