As real world evidence (RWE) becomes a more prevalent resource for confirming and expanding product benefit-risk profiles, non-randomized studies (NRS) are emerging as a valuable generator of real world data (RWD). Joan Largent – Senior Director, Epidemiology and Outcomes Research at IQVIA – discusses the findings of her recent study and how researchers can utilize assessment tools for their ability to accurately assess NRS validity.

For more than 50 years, randomized controlled trials (RCTs) have been used by the biopharmaceutical industry and regulators to evaluate the efficacy and safety of new medications as well as medical products that are being repurposed for new uses. But regulators and biopharmaceutical companies are being pushed to modernize their approaches to expedite drug development, which has resulted in increased attention to potential contributions of real world evidence (RWE).