Real-world evidence (RWE) has the power to guide smarter decisions throughout the development lifecycle. To fully unlock that value, it must be thoughtfully and systematically integrated so that robust evidence is available at the right time to inform key decisions by sponsors, regulators, and payers.

Study Overview

To make integrated RWE generation more actionable, this article published in Therapeutic Innovation & Regulatory Science proposes a phased approach that links evidence generation to clinical development investment. The framework emphasizes coordinating RWE activities with key decision points across the product lifecycle—from preclinical planning through post-market evaluation—and highlights the value of involving trained epidemiologists in study design and execution. 

Together, these strategies offer a pathway to more informed, timely, and impactful decisions throughout the development journey.

Access the full article here.