Posted by Michael Wonder on 13 Aug 2018
Real world evidence and real world data for evaluating drug safety and effectiveness
13 August 2018 - For hundreds of years, the development of new medical treatments relied on “real-world” experience.
Discoveries such as citrus fruit curing scurvy described in the 1700s or insulin as a treatment for diabetes in the 1920s long preceded the advent of the modern randomised clinical trial. What these diseases had in common was a reliable method of diagnosis, a predictable clinical course, and a large and obvious effect of the treatment.
Under the 21st Century Cures Act, the FDA is tasked with developing a program to evaluate the use of real world evidence to support approval of new indications for approved drugs or to satisfy post-approval study requirements.
