24 February 2020 - The Institute for Clinical and Economic Review (ICER), a small but influential Boston-based research group, has signed a deal with private technology company Aetion to help it use patient health data in its reports on whether individual drugs are priced properly.
Large national regulators, including the U.S. FDA and United Kingdom's NICE, are considering increasing the use of data gathered outside of clinical trials on the effectiveness of treatments, often referred to as real-world data.
The FDA is running a pilot project using Aetion's technology to analyze insurance claims to try to replicate clinical trial results, as part of a requirement to comply with healthcare legislation called the 21st Century Cures Act. It is seeking to determine under what circumstances such data could replace clinical trials, which have long been the foundation of medicine regulation.