The Regulatory Outlook for Real-World Evidence Shows Promise

Thanks to the advancement of technology-driven solutions that enable the acquisition, processing, and analysis of real-world data (RWD) to generate real-world evidence (RWE), the opportunities to improve and modernize both clinical research and clinical practice are growing rapidly. Applications for RWE are rapidly evolving, primarily in response to the COVID-19 pandemic along with the upcoming RWE Guidance by the Food and Drug Administration (FDA) scheduled to be released by the end of the year.  In this context, the value of insights derived from large-scale data sets that incorporate RWD continues to increase, particularly with respect to how these insights inform evidentiary-based best practices for improving patient care and for discerning the fitness for use of RWE based upon specific use cases. 

Real-World Evidence and the Regulatory Landscape

To meet the evolving regulatory considerations for the use of RWE, the FDA guidance will establish a framework for delineating the quality and relevance of RWD as well as for the methodologies used to generate RWE. The FDA is also adapting to the changing technological landscape. The agency released the Technology Modernization Action Plan (TMAP) in 2019 and Data Modernization Action Plan (DMAP) a few weeks ago to demonstrate its commitment to:

• Modernize its own data and technology infrastructure
• Establish best practices for receiving and evaluating electronic health data
• Expand its capabilities to securely analyze large RWD sources in a more continuous fashion 

Verana Health’s Commitment to Real-World Evidence 

At Verana Health, we are actively partnering with all stakeholders across the healthcare data ecosystem—including patients, providers, researchers, and regulatory agencies—to help optimize the value of RWE. We are excited to participate in several public-private partnerships that intersect with the FDA, academic organizations, and the pharmaceutical/biotechnology industry, including: 

• The Clinical Trials Transformation Initiative (CTTI)
• The Duke Clinical Research Institute Think Tank Series
• The Reagan Udall Foundation’s COVID-19 Evidence Accelerator Program 

The Future for Real-World Evidence is Bright

We at Verana Health aspire to assist with realizing the full potential of RWE to guide health care delivery, clinical research, and regulatory decision-making using transformative approaches and continuous technological refinements.