The White House Office of Science and Technology Policy (OSTP) published two Requests for Information regarding emergency clinical trials, with comment periods ending at 5:00 PM ET today, January 27, 2023.
Emergency Clinical Trials
The first Request for Information focused on clinical research infrastructure and emergency clinical trials. The RFI notes that the current clinical trial infrastructure in the United states is “not well prepared to carry out coordinated, large-scale clinical research in the event of an outbreak of infectious disease or other public health emergency.” This has led researchers and decisionmakers with a “series of relatively small, often inconclusive studies” and difficulty with collecting data for a larger-scale analysis. The RFI also notes that the current approach to clinical research in the emergency setting fails to include patients and health care providers in underserved areas, thereby contributing to a lack of diversity among clinical trial participants and investigators who lead clinical trials.
OTSP is particularly interested in responses from research institutions, clinical trialists, health care providers interested in clinical research, contract research organizations (CROs) and other clinical trial service providers, pharmaceutical and biotechnology companies, and community health care organizations.
OTSP cites one potential approach as a centralized federal structure that with membership from different agencies who hold relevant expertise. another function would be to develop emergency clinical trial protocols, which could vary in complexity. Some trials may be simple, focused on measuring the scope of an outbreak or the course of a disease, while others would be more complex and require more or different data elements from those that would be captured through standard medical treatment.
OTSP is also looking for comments on how emergency clinical trial data could be managed to help researchers better access the data and analyze the results. One potential idea is collecting data from emergency clinical trials into a centralized data repository or small set of repositories, with a central biorepository for biospecimens collected during the trials.
As far as specific information sought by the RFI regarding how to govern emergency clinical trials response, some of the information OTSP is looking for include:
- Descriptions of models that could be used to establish a U.S.-level governance structure for emergency clinical trials.
- Criteria that should be applied in determining when coordinated and potentially large-scale clinical research is needed to address an outbreak of disease or other biological incident, including signals or indicators that should be considered.
- What factors relating to the outbreak or incident (e.g., scope, location, severity) should be considered when determining what types of studies are needed.
- How to track institutions, networks, and sites that might be able to participate in emergency research, focusing on adequate geographic coverage, domestically and internationally.
- Best practices for designing trials so that they capture the data needed without unnecessary complexity that can complicate execution.
- Best practices for designing trials that can enroll vulnerable populations, such as children, as needed in particular circumstances.
- How to structure a data repository and a biorepository for emergency clinical trial data and specimens.
As far as specific information sought by OTSP regarding how to identify and incentivize research institutions/networks and build diversity and equity, they are looking for information on:
- How to identify institutions and other sites that may have an existing interest in, or familiarity with, emergency clinical trial research.
- Effective ways to increase diversity among study participants and investigators, and ways to expand clinical research sites into underserved areas.
- Incentives to encourage participation in emergency clinical trial research.
Comments for this RFI were initially due December 27, 2022, but the deadline has been extended to January 27, 2023, at 5:00 PM ET.
Viable Technical Strategies
The second Request for Information focused on viable technical strategies to distribute clinical trial protocols and capture clinical trial data using common application programming interfaces (APIs) in the pre-emergency phase and emergency settings. This RFI is also helping officials consider whether there is value in a pilot project to operationalize data capture in the near term, i.e., within the next year or so. If this pilot program is implemented, it could provide training for sites in underserved communities, enlarging and strengthening the clinical trial infrastructure in the United States.
The request for information outlines a multi-step use case that OTSP wishes responders to consider when submitting their comments. The multi-step use case seems to outline the way OTSP currently views the future of potential emergency clinical trials. In comments, OTSP would like to hear stakeholders’ opinions on the feasibility of all steps included in the hypothetical use case as well as input on how much of the use case could be operationalized in a pilot project.
Additional information sought through the RFI includes how the government and external stakeholders can leverage United States Core Data for Interoperability (USCDI) and future extensions of those standards to support emergency clinical trial research. OTSP is also seeking information about the use of specific APIs and how they can be used to support research in emergency settings and in the pre-emergency phase. Similar to the other RFI, OTSP is seeking comments on how to manage data through a central repository or repositories, to be made available to researchers beyond the patient’s home institution.
Comments for this RFI were initially due December 27, 2022, but the deadline was extended to January 27, 2023, at 5:00 PM ET.