The Council on Governmental Relations (COGR), representing over 200 U.S. research institutions, submitted a detailed response to the White House Office of Science and Technology Policy's Request for Information on enhancing clinical research infrastructure for emergency clinical trials (ECR). Drawing on extensive experience from the COVID-19 pandemic, COGR emphasized the necessity for rapid, coordinated efforts among government, academia, industry, and community health organizations to facilitate effective clinical research responses during public health emergencies. Their recommendations stressed the importance of establishing multidisciplinary working groups to identify and resolve logistical, financial, and regulatory barriers, and advocated for process mapping to anticipate and mitigate challenges at both traditional and non-traditional research sites.
COGR also highlighted the need to improve diversity and equity in emergency clinical research by leveraging existing networks, tailoring regulatory requirements for community-based and non-traditional sites, and ensuring adequate federal support for research infrastructure and technology. The organization proposed a “hub and spoke” model to maintain a state of readiness across sites and recommended demonstration projects to operationalize and refine this approach. Furthermore, COGR underscored the importance of developing universally accepted master trial agreements and anticipated the necessity of mechanisms for global collaboration and regulatory flexibilities. They concluded by reaffirming their support for OSTP’s initiatives and willingness to continue working collaboratively to strengthen the nation’s emergency clinical research capabilities.
