By Grail Sipes, Assistant Director for Biomedical Regulatory Policy, White House Office of Science and Technology Policy
Testing medical interventions through clinical trials is an essential part of creating and delivering effective health care for everyone in America. Strengthening our clinical trials infrastructure will help us improve health outcomes, and will drive forward the Biden Cancer Moonshot goal to end cancer as we know it.
The White House Office of Science and Technology Policy (OSTP) is leading a whole-of-government approach to bolster clinical trial capacity in the United States. The Clinical Trials Readiness initiative aims to build a stronger and more diverse clinical trial infrastructure. By making clinical trials faster, more inclusive, simpler, and more efficient across a wide range of communities and clinical settings, we can better contain infectious disease outbreaks and also accelerate the development of treatments for cancer and other diseases. In October 2022, OSTP issued two Requests for Information (RFIs) to gather feedback about strengthening the clinical trials infrastructure and optimizing clinical trial data capture. Summaries of the responses to both RFIs, as well as the compiled responses themselves, are available below.
Feedback received through both RFIs and during a roundtable and listening session held earlier this year support the urgent need for better preparation for outbreaks and greater efficiency during non-emergency times, including:
- Enabling more diverse participation in clinical trials, through increased community outreach and supporting a diverse workforce;
- Shifting to more pragmatic and streamlined trial designs that are simpler for both health care providers and patients;
- Training more sites to carry out research in advance of an emergency, for fast and efficient response in case of an outbreak;
- Developing a coordinated federal approach to outbreak response; and
- Vetting and piloting more efficient data capture for clinical trials, including by improving and leveraging electronic health records systems, and making data available to researchers more rapidly.
To advance these goals, OSTP has collaborated with the Advanced Research Projects Agency for Health (ARPA-H) on a first use case for ARPANET-H, a nationwide hub-and-spoke network that will drive innovation across our communities to improve the lives of people with cancer and other diseases. In a critical step forward, the Biden Cancer Moonshot recently announced ARPA-H’s commitment to accelerating and improving clinical trials for cancer and other diseases as a first project within the ARPANET-H network of sites. Through the Advancing Clinical Trials Readiness project, ARPA-H will challenge participants to innovate in key areas such as pragmatic trial designs, faster and more inclusive patient enrollment, and more efficient data capture.
This investment by ARPA-H is just one piece of the puzzle. OSTP is working across the federal government and with the private sector on additional actions:
- OSTP is working with the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) and the HL7 FHIR Accelerator community on faster clinical trial data capture. Vulcan, together with CodeX and others, is stepping up to speed the development of standardized approaches to data exchange, with the goal of piloting faster and more inclusive data capture for multi-site clinical trials.
- OSTP is coordinating its Clinical Trials Readiness efforts with other initiatives within the Cancer Moonshot such as CancerX, a public-private partnership established to drive innovation in the fight against cancer—including through demonstration projects piloting new technologies for research and patient care.
- Under the National Biodefense Strategy, which calls for a more effective clinical trials infrastructure with more rapid response capability, OSTP has engaged with key federal agencies to plan for a more pragmatic, streamlined approach to research, and to facilitate federal governance of outbreak response.
Over the next six months, OSTP will be working with federal partners and the larger clinical research community to communicate about next steps, including unveiling plans to facilitate pragmatic trials across multiple sites and diverse communities; launching pilots to demonstrate more efficient data capture; and pursuing opportunities to engage with communities and establish trust to support clinical research and public health.
- Summary of Responses to White House Office of Science and Technology Policy Request for Information on Clinical Research Infrastructure and Emergency Clinical Trials
- Responses to the White House Office of Science and Technology Policy Request for Information on Clinical Research Infrastructure and Emergency Clinical Trials
- Summary of Responses to White House Office of Science and Technology Policy Request for Information on Data Collection for Emergency Clinical Trials and Interoperability Pilot
- Responses to White House Office of Science and Technology Policy Request for Information on Data Collection for Emergency Clinical Trials and Interoperability Pilot