A Regulatory Roadmap for Real World Evidence

The need for real world evidence is growing beyond its original footprint of post-market intelligence, with uses now including regulatory approval, proof of value, maximized access and more.  However, without a true understanding of the regulatory requirements around real world evidence, there is a risk of a “Goldilocks effect”— gathering either not enough information, the wrong information, or far more information than they need. Stuart McCully, PhD, Vice President and Tara Isherwood, Senior Director, Real World Clinical Consulting, discuss the key information developers need in order to plan studies that will get them the intel that they need, the right way.For more on real world evidence from across Syneos Health, check out our interviews with Alastair MacDonald in Episode 31, and Dave Thompson in Episode 1.Like what you’re hearing?  Be sure to rate and review us!  We want to hear from you!  If there’s a topic you’d like us to cover on a future episode, contact us at [email protected]. The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.  If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you’re hearing? Be sure to rate and review us!  We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at [email protected].