Sneak Preview: OSTP Seeks Input on Health Security Trials RFIs
(The following is excerpted from a recent Thompson Grants Compliance Expert article.) The Office of Science and Technology Policy (OSTP) has issued two requests for information (RFIs) to help guide its efforts to ensure that institutions and researchers can quickly and efficiently conduct large-scale clinical trials when needed to address outbreaks of disease and other emergencies. The RFIs aim to further the goals outlined in the White House’s recently released National Biodefense Strategy.
In the first RFI, issued on Oct. 26, OSTP — in coordination with the National Security Council — asks for comments on how to establish a U.S. clinical trials infrastructure that is ready to respond to outbreaks of disease and other biological incidents on an emergency basis. “We need to revisit processes currently in place within our clinical trials infrastructure that can lead to … fragmentation and inefficiency,” OSTP said, when the national is struggling to respond to an emergency, particularly a biological emergency.
In the second request, issued Oct. 28, OSTP, in partnership with the National Security Council and the Office of the National Coordinator for Health Information Technology, is asking for input “on viable technical strategies to distribute clinical trial protocols and capture clinical trial data using common application programming interfaces (APIs).” OSTP is considering setting up a pilot or demonstration project “to operationalize data capture in the near term, for example, within 6-12 months of the close of comments” on the RFI, and is particularly interested in stakeholder feedback on this approach.
OSTP maintains that without a plan for emergency clinical research, individual researchers and institutions often proceed separately and individual with their own studies when an emergency arises. Instead, OSTP wants to put a process in place for federal coordination in responding to an emergency and for getting a large-scale clinical trial up and running promptly. “We need a process for developing emergency clinical trial protocols, and for capturing trial data through consistent data elements reported across participating sites,” OSTP said. “And we need to carry out clinical research in a way that increases diversity among trial participants as well as among the investigators who lead clinical trials. This is critical not only to ensure equity, but to ensure the quality of our research results.”
(The full version of this story has now been made available to all for a limited time here.)
Join us for our following Thompson Grants events:
Federal Grants Forum | Dec. 7-9, 2022 | Fort Lauderdale, Fla.
Nonprofit Legal, Finance, and Grants Conference | April 6-7, 2023 | Washington, D.C.
