The AAMC submitted a Jan. 27 letter to the White House Office of Science and Technology Policy (OSTP) in a response to a request for information (RFI) on ways to build clinical research capacity “to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies.” This effort is in accordance with the 2022 National Biodefense Strategy and Implementation Plan, the American Pandemic Preparedness Plan, and in partnership with the National Security Council.
In the letter, the AAMC acknowledged the medical schools and teaching hospitals that were on the front lines of the COVID-19 response and agreed that “the inability to fully and rapidly coordinate efforts on a national scale hampered the COVID-19 pandemic response on many fronts, including the lack of aggregated clinical data that could have sped our understanding of the infectious disease’s transmission, assessment of whether certain treatments were effective, and development of diagnostics and therapeutics.” The AAMC’s comments also supported the OSTP’s interest in increasing the diversity of clinical trial participants and investigators, emphasizing the exclusion of communities and populations that have been historically marginalized in clinical research and the resulting disparate impact of COVID-19 on those communities.
Among other recommendations, the association urged the OSTP to establish one or more multisector advisory groups to develop coordinating structures for this effort. These groups should also be tasked with developing criteria for the activation of clinical trials through the resulting networks. In addition, the AAMC suggested that the OSTP utilize the term “coordinated clinical trial readiness” in lieu of “emergency research” to avoid the suggestion that clinical research that takes place during a pandemic or other related incident would be undertaken without the need for informed consent.
The OSTP also issued a separate but related RFI on ways to best operationalize clinical trial protocol distribution and data capture, Data Collection for Emergency Clinical Trials and Interoperability Pilot.