Feedback Sought on Strengthening Capacity for Emergency Clinical Trials

The White House Office of Science and Technology Policy (OSTP) and National Security council recently released a Request for Information seeking ideas on strengthening the national capacity of clinical trial infrastructure and emergency clinical trials. An OSTP blog discusses the importance of having a robust clinical trial infrastructure prepared for an emergency as well as the importance of inclusive and well-designed studies.

Echoing the OSTP post, it is a good time to look back on our clinical trial efforts as the public health emergency moves into a new phase. What worked? What did not? How can we apply lessons learned moving forward? In my earlier reflections on whether NIH made fast and meaningful contributions to respond to the pandemic, I noted, for instance, the importance of (a) working closely with all partners to leverage existing infrastructure, (b) leveraging newly available funding to pivot rapidly in response to the pandemic, and (c) thinking about more than just awards and dollars but rather the generation meaningful results within a remarkably short time. More on our response during the pandemic may be found in these NIH Extramural Nexus posts.

What are your thoughts? Some areas OSTP is interested in include (from their post):

• What do institutions and scientists need to keep the research base warm and ready for action?
• How can we get the enterprise rowing in the same direction from day one, asking the right scientific questions, and efficiently coordinating resources?
• How do we ensure that all Americans and all communities have the opportunity to participate in high-quality, impactful clinical research studies?
• How can we make sure this is organized and governed appropriately, across public and private sectors?
• Are there opportunities to make advance agreements to streamline the research response in real time?

You are welcome to send ideas in response to the Request for Information via email to emergencyclinicaltrials@ostp.eop.gov (please include “Emergency Clinical Trials RFI” in the subject line).