Reagan-Udall Foundation for the FDA Issues Paper on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics

Details recommendations for research activities in the context of a public health emergency

(February 4, 2022) The Reagan-Udall Foundation for the FDA, at the request of the U.S. Food and Drug Administration, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and provides actionable recommendations to enhance the scope, prioritization, and communication of research activities within the context of a public health emergency. The report can be viewed here.

In September of 2021, the Foundation convened a group of federal leaders and other key stakeholders for a virtual public workshop. The event provided a forum to discuss findings from the experience of the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly known as Operation Warp Speed) efforts to clinically evaluate therapeutics during the public health emergency. Recommendations were developed by a diverse group of stakeholders including leaders from across government bodies, think tanks, nonprofits, and industry associations, and reflect feedback and guidance from the Initiative’s leadership group, which includes representatives from the Department of Health and Human Services, the Department of Defense, and Veterans Affairs. 

“The FDA Foundation is gratified to play a role in bringing these initial lessons learned to a broader audience,” remarked FDA Foundation CEO Susan C. Winckler, RPh, Esq. “The ongoing public health emergency has highlighted the need to build and maintain a more agile clinical research infrastructure, as well as to implement much-needed changes to better prepare for the future.”

As the health and research communities continue to adapt to changing circumstances in the current pandemic, they recognize the importance of leveraging their experiences from COVID-19. This paper enumerates strategies to support a more unified approach to a future pandemic or other public health emergency and the need for stronger community partnerships and community support to create better engagement in clinical trials. A set of preliminary ‘lessons learned’ were collected and discussed across three broad categories:

(1) Research, Scoping, and Prioritization,

(2) Infrastructure and Resource, and

(3) Clinical Trial Execution.

“Change is a continuous process,” added Kevin Bugin, PhD, who organized and co-led the workshop on behalf of the U.S. Food and Drug Administration and serves as deputy director of operations for the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “While progress has been made to improve clinical research during the pandemic, we need to continue exploring the lessons learned so we can be prepared, not only for future pandemics or other public health emergencies, but to enable the best clinical research for the benefit of patients.” 

The Lessons Learned report provides valuable insights into how to develop response efforts for future public health emergencies as well as improve clinical research and community health broadly.  While there continues to be a public health emergency, there is a recognition of the importance of exploring immediate application of lessons as well as more long-term efforts.

About the Reagan-Udall Foundation for the FDA

The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and policies to keep pace with today’s rapidly evolving science.

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