Real-world evidence (RWE) is gaining traction in the regulatory space. Companies are using this reliable evidence to examine the longer-term effects of drugs entering the market and, in some scenarios, proposing its use in support of clinical trials for regulatory decision-making. Recently, the FDA committed to realizing the full potential of RWE and its ability to accelerate innovation and treatments for patients who need them. 

While clinical trials remain the gold standard for determining drug efficacy, RWE plays an increasingly valuable role in safety surveillance once those trials are over and the drug enters the market. It also provides an opportunity to look at the drug from a more inclusive lens. 

You don't have to look further than the blockbuster drug Ozempic to see the impact of RWE. Ozempic was originally approved as a diabetes drug but quickly gained popularity as a weight-loss solution for millions of Americans. RWE allows researchers to monitor the safety and possible side effects for those non-diabetic individuals using Ozempic for weight loss, which was not the intention of the original clinical trial.