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The Regulatory Outlook for Real-World Evidence Shows Promise

Author: Dr. Matthew Roe
April 2021
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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: 

Of note, my participation as a team lead on a CTTI project—which will address embedding clinical trials in routine health care delivery settings—as well as my involvement in efforts to guide the creation of a Tech and Data Clinical Trials Council—exemplify Verana Health’s engagement in the field and underscore our strong commitment to advancing RWE. Additionally, scientific and methodological leaders from Verana Health are actively involved with the Reagan-Udall Foundation’s COVID-19 Evidence Accelerator program, contributing to efforts focused upon optimizing the use of RWE to inform treatments and responses to the pandemic.  

The Future for Real-World Evidence is Bright

I expect that 2021 will be a year of substantial advancement in the RWE environment. 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. 

About the Author

Dr. Matthew Roe is the Chief Medical Officer at Verana Health, where he leads the cross therapeutic medical team working to ensure the clinical validity and scientific integrity of the company’s research.