May 01, 2019
Pitfalls to Avoid When Leveraging Clinical Imaging Data for RWE Programs
In December 2018, the FDA announced its new framework for the real world evidence (RWE) program, which would require including imaging data alongside claims, electronic health records (EHRs) and other datasets in clinical research. In issuing this new framework, regulators underlined the continued importance of using contextualized, quality datasets to make drug development faster, safer, more efficient and less expensive.
Because of this move to include authentic patient data in the drug development process, imaging data has become an essential part of RWE as it can accelerate the development cycle and improve the confidence in the final clinical arguments in support of drugs going to market.