Real World Evidence (RWE) In Regulatory Decision Making: Establishing Study Credibility And Totality Of Evidence

By Rachel E. Sobel, DrPH, FISPE, VP Epidemiology and Strategic Engagement, SERRM

I was pleased to be a part of the Duke-Margolis webinar on January 15, 2020 entitled, "Bolstering RWE Study Credibility and Its Role in a Totality of Evidence Approach," and thought it important to share some of the learnings from the session.

The webinar was designed to summarize 2 new whitepapers that were just released. The first, “Demonstrating the Credibility of Non-Interventional Studies Using Secondary Data,” described when and why a non-interventional study (NIS) is the preferred, only, or complementary option compared to interventional studies such as randomized controlled trials (RCTs). It also covered some of the key regulatory definitions and highlighted some of the common methodologic considerations (e.g., assessing the direction and magnitude of bias).

The second whitepaper entitled, “Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness” outlined what drives the Totality of Evidence considerations when using RWE.