Accelerating the Development of Relevant Evidence in Healthcare
Marcus D Wilson, Pharm.D.; President, HealthCore
September 29 in the Fralin Auditorium, Fralin Hall 102
Hosted by Dr. Carla Finkielstein
The US healthcare system is plagued by a number of issues that jeopardize sustainability in its current form. These issues range from fragmentation and poor care coordination to misaligned incentives and rapidly escalating care and technology costs. However, an issue that is less widely appreciated is the significant gap in relevant medical evidence needed to inform decisions related to use and payment once a product is on the market. This gap is evident when examining the evidentiary requirements set forth by regulators, such as FDA, for manufacturers to gain approval to market a products as compared to the evidentiary needs of providers and payers in the delivery and payment for effective and efficient patient care. It is increasingly clear to many that the current research system, which is built around the randomized clinical trial is insufficient to close these gaps.
As real-world data from payer claims systems and electronic medical records from providers become increasingly available and as research methods utilization these data sources mature, payers and now regulators are beginning to focus more attention on the potential contribution of real-world evidence to closing this evidence gap. This presentation will review the extent of the issue, explore the underlying causes and outline the evolution of the research infrastructure that empowers new research designs and the potential for revolutionary changes in the research process over the next 5 years and point out key challenges to overcome to effectively close this gap.
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Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-World Evidence: What is it and what can it tell us? N Engl J Med. 2016 Dec 8;375(23):2293-2297.