FDA And Its Advisers Struggle With Real-World Evidence Definition

FDA and its advisers are struggling to decipher whether Congress' definition of real-world evidence excludes data gathered as part of a single-arm trial as they move forward on a 21st Century Cures work plan that calls for studying the use of RWE for new drug indications and post-approval studies. Other hurdles include a need to draft guidance on good clinical practices for such data, develop the infrastructure to gather and use RWE for both manufacturers and health care deliverers and...