On January 28, 2016, the FDA and Commonwealth Informatics entered into a two-year agreement where they will work together to develop a platform to help the Agency assess drug safety data. The agreement was signed as part of the FDA’s 21st Century Review Initiative, which is a set of standards that was developed in an effort to organize and integrate the drug review process, as well as ensure that all decision makers are heard.
Commonwealth Informatics is a Massachusetts-based analytics company that provides cloud-based products and services to regulators, academic professionals, government agencies, and life sciences companies to advance the way clinical data is analyzed. Prior to engaging with the FDA, Commonwealth created a platform called Commonwealth Clinical Data Analytics (CCDA). CCDA was developed in collaboration with the Army Pharmacovigilance Center and is used to monitor drug side effects experienced by more than 15 million patients.
Commonwealth plans to use CCDA as the foundation for its partnership with the FDA, making enhancements to the platform as necessary “to improve the speed and quality of data reviews and the critical analysis of drug safety data.” Commonwealth will do this with assistance from the FDA, as it will be providing scientific, statistical, and clinical support to help the company make improvements to the platform. By working together, the FDA and Commonwealth ultimately hope to “improve the speed, quality, and transparency of analyzing drug safety data,” allowing regulators to make more informed decisions.
At the project’s outset, Commonwealth will host the program using its internal cloud infrastructure. As the platform progresses it will be integrated with some of the FDA’s custom-developed tools and programs, such as the openFDA platform. As such, Commonwealth eventually plans to turn the platform over to FDA, who will host the program internally at some point in the future.