ARPANET-H Network Activation Call: Stakeholder Intelligence for Advancing Clinical Trial Readiness (ACTR) Initiative

Introduction ARPANET-H is a nationwide health innovation network that connects people, innovators, and institutions, mobilizing these capabilities to help transformative innovations reach both the market and the end-user, and bring partners together to close innovation transition gaps that would not be addressed otherwise. The Customer Experience Hub of ARPANET-H is focused on designing for the American people and their caregivers, putting people at the center of ARPA-H programs and projects, and developing technologies that will be accessible, desirable, and affordable for all. This Hub will take a human-centered approach to design products and services that people need and ask for, enthusiastically. ACTR Initiative Summary (More information is available in the Initiative Description): ARPA-H's Advancing Clinical Trial Readiness (ACTR) initiative aims to establish a robust, decentralized clinical trial infrastructure. This initiative will advance, integrate, and extend clinical trial capabilities so that ARPA-H has efficient mechanisms to evaluate new technologies, therapies, and platforms. Ambitiously, this effort seeks to enable 90% of all Americans to take part in a clinical trial within a half hour of their home. To achieve this goal, the effort will address challenges with the current clinical trial model that include, but are not limited to: (1) resource-intensive enrollment processes that often result in non-representative populations within studies; (2) the potential for discrepancy in outcomes from running Randomized Controlled Trials (RCTs) and running studies in messy, real-world settings, and (3) interoperability challenges among and across electronic health records (EHRs), electronic data capture (EDC) systems, and systems that manage clinical protocols. ARPA-H seeks novel clinical trial infrastructure designs that will enable rapid distribution of common clinical trial protocols across multiple geographic locations and sites in the case of a national emergency. The ACTR initiative will develop, evaluate, and integrate new tools and technologies to enable faster, less expensive, decentralized trials operating closer to/at points of care that are more representative across geography, age, gender, race, ethnicity, and socioeconomic status. The initiative will culminate with compelling demonstrations that show regulators, clinical investigator sites, evaluators, EHR vendors, and the pharmaceutical industry the feasibility and utility of rapid, representative, and decentralized trials with trustworthy data. This effort is comprised of five technical task areas: Task 1: Enrollment and consent Task 2: Decentralized trials Task 3: Trial protocols and data collection Task 4: Test and evaluation Task 5: Transition ARPANET-H Network Activation Call Objective The ACTR program will require collaboration across a diverse set of organizations, firms, and institutions to reach the American public more effectively than has been done before, including traditionally unreached populations in the US. To reach this ambitious goal, ARPANET-H is interested in and greatly values stakeholder feedback on the following questions to learn and benefit from a broad range of perspectives. Answer any of the prompts below where your team has a perspective and/or specialized or high-performing capabilities in up to 1000 characters each. All questions are optional so please respond only to the questions that are relevant for you. Before answering the questions, please read the full initiative description linked here: https://www.customerexperiencehub.org/actr-initiative. Note that this is a draft initiative description shared to collect feedback per the below questions, including to understand the limits of today’s capabilities to inform future ARPA-H investments. NOTE : Feedback provided to ARPANET-H is for stakeholder intelligence gathering only; responses will not provide any advantage or disadvantage to a respondent for any future related funding opportunity or award. Feedback format and content : Feedback responses should not be greater than 1000 characters per question. Responses shall be written in English. Feedback response date : Feedback should be provided by Friday, December 1, 11:59pm EST.