Biden-Harris Administration’s ARPA-H initiative invests to improve clinical trials and drive better health outcomes

New effort aims to increase speed, improve reliability of testing for treatments

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced it will take action to improve the nation’s ability to conduct clinical trials safely, quickly, and equitably and to improve clinical trial access for people in communities across the country as the first initiative within the recently launched ARPANET-H Health Innovation Network.

The goal of Advancing Clinical Trial Readiness (ACTR) is to enable 90% of all eligible Americans to take part in a clinical trial within a half hour of their home. To do so, ACTR will leverage the nationwide capabilities and reach of the ARPANET-H Customer Experience Hub by pursuing activities with a diverse array of stakeholders in order to advance, integrate, and extend clinical trial capabilities that overcome challenges in evaluating new technologies, therapies, and platforms.

"Clinical trials are essential to evaluating potentially life-saving breakthroughs and getting them to patients, including in times of rapid response, such as during national emergencies," said ARPA-H Director Renee Wegrzyn, Ph.D. "The Advancing Clinical Trial Readiness initiative activates the ARPANET-H health innovation network as we work with organizations from across the country to advance technologies and insights to create a robust national clinical trial infrastructure."

Working together with patient volunteers, clinical trials help researchers understand what treatments work, gathering a variety of data to help identify better ways to improve patients’ health. Yet many challenges in conducting clinical trials are slowing the speed at which new treatments can get to patients, such as lack of interoperability across electronic health records, enrollment processes that can lead to non-representative study populations, complex study protocols, lack of access to people living in certain parts of the United States, and the myriad and inconsistent variables involved in running trials in real-world settings, or the cost in running trials in controlled settings.

ACTR will work with groups across the country, including innovators, industry, patients, academia, hospital centers, community health centers, and non-traditional partners, such as retail pharmacies or home health innovators, to build faster, less expensive trials with decentralized processes. The effort will also build trials that operate closer to, or at, points of care and are representative of our nation’s geography, age, gender, race, ethnicity, and socioeconomic groups.

ARPA-H will leverage and expand upon existing clinical trial networks by extending their reach and expanding their ability to run common trials embedded in health care settings.

"Recent advances in technologies, including artificial intelligence, digital health technologies, and machine learning — along with open standards — enable new opportunities to increase the speed, improve access, and expand the diversity of clinical trials," said ARPA-H Resilient Systems Mission Office Director Jennifer Roberts, Ph.D. "Through this effort, we want to develop novel innovations to distribute common protocols across many more locations so that we can change the current paradigm and open the door to faster, cheaper, and more representative trials."

ACTR will work through a series of challenges and test cases, also called use cases, in areas such as enrollment and consent, decentralized trials in health care settings, distribution of common trial protocols, and data collection.

ARPA-H is currently seeking feedback through a Network Activation Call on ACTR, which can be found at the Customer Experience hub website. All organizations with relevant experience and expertise are invited to respond, including those beyond the current Customer Experience hub network, and the deadline to provide feedback is December 1, 2023. Following the feedback period, ARPA-H will release the final initiative description and funding opportunity, likely in the coming months.

For more information about ARPANET-H, the agency's nationwide health innovation network that connects people, innovators, and institutions to accelerate better health outcomes for everyone, visit the ARPANET-H webpage. Organizations interested in becoming a part of the Customer Experience Hub consortium – or spoke network – can learn more at the How to Become a Spoke webpage on the Customer Experience Hub website.