The U.S. Food and Drug Administration is considering ways to expand the use of real-world evidence to better measure the effectiveness of some treatments in certain cases.
A Healthcare Economist blog post points to statements by the federal agency which suggest its experience in using electronic health records to inform drug safety would serve as a foundation for informing the use of EHR data to analyze a drug’s effectiveness.
“The RWE Program will involve the establishment of demonstration projects, engagement with stakeholders, the use of internal processes that bring senior leadership input into the evaluation of RWE and promote shared learning and consistency in applying the framework, and the development of guidance documents to assist sponsors interested in using RWE to support their work,” the FDA said in a statement in December.
To read the full blog post on Healthcare Economist, click here.
