Real-World Studies and Randomized Controlled Trials: A Podcast Discussion of the Relative Strengths and Limitations of These Complementary Designs for Cancer Research.

Randomized controlled trials (RCTs) are the benchmark for assessing the safety and efficacy of treatments but are subject to some inherent limitations, such as restrictive inclusion criteria and underrepresentation of certain patient groups. Studies based on diverse real-world data sources provide complementary evidence that can help fill knowledge gaps, particularly by providing safety and outcome data for patients not typically included in RCTs. However, real-world data studies have their own limitations. This podcast aims to be a resource for clinicians by exploring the strengths and limitations of RCTs and real-world studies in the context of cancer research. The hosts, both of whom are practicing oncologists, provide context for the emergence of modern real-world studies and advice for interpreting real-world evidence. As a supplement to learnings from RCTs, real-world evidence can inform the treatment decision-making process in the clinic and support decisions made by regulatory bodies. This podcast is part 1 of a three-part series discussing real-world studies.Podcast and infographic available for this article. Podcast video (MP4 66494 KB).