By Sajjad Raza, MD, PhD, MSM; Kathy Lang, PhD

Randomized controlled trials provide critically needed evidence of drugs’ safety and efficacy, yet their results are not always generalizable to diverse populations in less idealized settings. Thus, we need data beyond controlled trials. Further, there is growing inclination toward precision medicine for individualizing therapy to the patient, and there is a shift toward specialty medications with more narrow indications and smaller patient populations, creating a need for creative and nimble means for data collection and analysis. These emerging trends suggest that the drug development landscape is inherently evolving to a place where use of real-world data will not only grow but will become pivotal as long as some inherent challenges can be satisfactorily addressed.

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