The goal of Algorithm CErtainty Tool Kit (ACE-IT) is to help organize and inform the user’s judgement to determine the fitness of an algorithm for use as an endpoint in a target safety study of the user’s design. The Reagan-Udall Foundation for the FDA collaborates with University of Massachusetts, Chan Medical School (UMASS) on developing a framework to evaluate the suitability of specific claims-based algorithms for a targeted use case in the ICD-10 era. Our ACE-IT pipeline includes following seven clinical area of interest:
Major Adverse Cardiovascular Events (MACE)
The MACE Project evaluated claims-based algorithms for MACE as MACE are important safety endpoints for a variety of drug classes. The ACE-IT tool that evaluates and conducts 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 was developed. The publication can be found here
Maternal/Birth outcomes
The ACE-IT tool with maternal/birth outcomes is currently in progress. This work will follow the infrastructure of MACE project and continue to refine and adapt the existing ACE-IT for certain maternal/birth outcomes in pregnancy studies.
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 IMEDS@reaganudall.org.