Clinical Informatics News November 11, 2019
The 21st Century Cures Act, passed in 2016, placed additional focus on real world data to support regulatory decision making, including new indications for approved drugs. In the legislation, Congress defined real world evidence as data regarding the usage or the potential benefits or risks of a drug derived from sources other than traditional clinical trials.
Those sources can be varied including electronic health records (EHRs), claims and billing activities, product and disease registries, patient-generated data including in home-use settings, and data gathered from other sources such as mobile devices.
But how do we know if these data are accurate? It’s an important and timely question, Dan Riskin told Clinical Research News. Riskin is founder of Verantos and Adjunct Professor...
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