The use of data from the real world to address clinical and policy-relevant questions that cannot be answered using data from clinical trials is garnering increased interest.

Real world evidence (RWE) is important. It complements data from randomized controlled trials (RCTs). However, both have limitations in design, interpretation, and extrapolation.

There has been a staggering increase in reporting of studies using real-world data over the past two decades.

In this 2019 study via @NatRevClinOncol, researchers explore the quality of RWD, provide a framework for the use of RWD and draw attention to the methodological pitfalls inherent to using RWD in studies of comparative effectiveness.

Researchers conclude that although the increasing use of real-world evidence in medical research (especially cancer) can offer important insights into outcomes achieved, observational nonrandomized methods are not likely to obviate the need for traditional clinical trials.

A 2019 publication in @JAMANetworkOpen found that only 15% of the US-based clinical trials published in high-impact journals could be feasibly replicated through real-world-data.