Episode 8 – How Real-World Data is Transforming FDA Approvals, Healthcare Decisions, and Drug Development with Dr. Richard Scranton

January 13, 2025

Episode 8 – How Real-World Data is Transforming FDA Approvals, Healthcare Decisions, and Drug Development with Dr. Richard Scranton

In this episode of Data Nerds in the OR, Dr. Bruce Ramshaw, Chief Medical Informatics Officer at Caresyntax, engages with Dr. Richard Scranton, an epidemiologist and healthcare leader, to explore the evolving role of real-world data (RWD) and evidence (RWE) in healthcare. The discussion spans Dr. Scranton’s career journey, innovative uses of RWD to support regulatory decisions, and the future of data-driven surgical care. Together, they highlight the power of integrating RWD into surgical practice to enhance outcomes, accelerate innovation, and make healthcare more efficient.

Key Topics Discussed

Introduction to Dr. Richard Scranton: From Navy clinician to biotech executive, Dr. Scranton shares his unique career path and early exposure to healthcare data systems.
Real-World Data for Regulatory Innovation: Examples of leveraging RWD to expedite FDA approvals and demonstrate safety and efficacy, especially in pediatric care.
Shifting the Regulatory Focus: Moving beyond harm identification to identify and quantify unexpected treatment benefits through RWE.
The Role of AI in Surgery: Opportunities for artificial intelligence and machine learning to streamline clinical trials, optimize workflows, and enhance decision-making in the OR.
Iterative Quality Improvement: How continuous data collection drives iterative improvements in surgical techniques, patient outcomes, and cost management.
Advancing Pediatric Care: The untapped potential of RWD to support pediatric surgical innovation, expanding access to life-saving interventions.