9 April 2019 - The terms real world data and real-world evidence have entered the medical lexicon to refer to data sources and analyses characterising routine health care delivery.
Real world date (RWD) and real world evidence (RWE) are most often defined by what they are not: information from experiments such as randomized clinical trials.
The proliferation of electronic health records (EHRs) and fast computers has made analyses of RWD to generate RWE both feasible and relatively inexpensive. For the pharmaceutical industry, the potential of this information to accelerate discovery and product approvals is tantalising, and has spawned the rapid growth of companies focused on using EHR data for this purpose.
The frenzy of interest in RWD has also been fueled by the FDA signalling receptiveness to consider these data sources in regulatory review, and recent publication of a framework for doing so.