The Advancing Clinical Trial Readiness (ACTR) initiative seeks to improve the nation’s ability to conduct clinical trials safely, quickly, and equitably. This is important to advance, integrate, and extend clinical trial capabilities that overcome challenges in evaluating 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. The ACTR program will require collaboration across a diverse set of organizations, firms, and institutions to reach the American public more effectively, including traditionally unreached populations in the US. To reach this goal, ARPANET-H is interested in and greatly values stakeholder feedback to learn and benefit from a broad range of perspectives.

The ARPANET-H Customer Experience Hub is issuing its first Network Activation Call in support of ACTR’s goals by seeking feedback on the ACTR initiative description, which can be found here. A Network Activation Call draws on the ARPANET-H network to source feedback at scale on program concepts, inform technical and funding approaches, and map the landscape of potential partners. It is designed to meaningfully engage diverse stakeholders, end-users, and non-traditional partners (including beyond the current network membership). Answer any of the prompts below where your team has a perspective and/or specialized or high-performing capabilities. The deadline to provide feedback is December 1, 2023. While not a requirement to respond to this Network Activation Call, organizations or institutions interested in becoming a part of the Customer Experience Hub spoke network can learn more at the How to Become a Spoke webpage.

ACTR Initiative Intake Form Questions

  • Organization Info (Name, Address, Organization Type, Phone Number, Email Address, POC Information )
  • Are you already a Customer Experience Hub Spoke? Note that Spoke membership is NOT required to respond to this Network Activation call.
  1. Which aspects of the initiative description do you see as most vital to meeting the goals of a) enabling faster, less expensive, decentralized, and more representative trials and b) providing demonstrations that show the feasibility and utility of these new approaches?
  2. What, if any, components should be added to this initiative description to best enable achievement of the initiative goals? Please note any regulatory considerations.
  3. What existing capabilities, novel innovations, or actions are required for each task to accomplish its goal?
    1. (a) Task 1: Enrollment and Consent
    2. (b) Task 2: Decentralized Trials
    3. (c) Task 3: Trial Protocols and Data Collection
    4. (d) Task 4: Test and Evaluation
    5. (e) Task 5: Transition
  4. What, if any, risks/challenges exist in the current framing of the initiative that would prevent it from succeeding? How might these be mitigated?
  5. The Initiative Description Appendix A proposes a progression of notional metrics and milestones that could serve as goal posts to understand the bounds of what’s possible today. When framing metrics and milestones, we are interested in understanding what goal posts would fall into the following categories. What quantitative or qualitative goals would you see as falling within these three categories:
    1. (a) Reasonable Baseline Demonstrations
    2. (b) Ambitious, aggressive goals that just might be feasible in a one- or two-year time horizon
    3. (c) Goals that would truly revolutionize the clinical trial space
  6. If you are aware of similar efforts already conducted to achieve these goals or analogous efforts in other use-cases, please note these below along with salient lessons learned from those experiences (both positive and negative results).
  7. Describe which types of patient populations you can access, why, and how, with an emphasis on traditionally hard-to-reach groups.
  8. Describe practical and scientific expertise your team has with: patient navigation, patient counseling, or patient consent for clinical trials.
  9. Describe expertise with using and innovating on: electronic health records, clinical trial management systems, or medical data standards.
  10. Describe experience you have with trial design, including standard, emerging, and completely novel approaches and the highest potential approaches for decentralized and pragmatic trials.
  11. Describe financial, logistical, regulatory, partnership, consortium membership requirements or other constraints that might prevent you from participating in this effort.
  12. Please describe the catchment area that your organization covers (city, county, state, region, etc.)

The ARPANET-H Customer Experience Hub is holding an additional opportunity to collaborate and learn more about the Advancing Clinical Trial Readiness (ACTR) Network Activation Call. Below you will find a registration link for the webinar taking place on Tuesday, November 21 at 3:00 PM ET.

  • Introduction and description of the ACTR Network Activation Call (Mike Stebbins, Program Executive of CX-Hub)
  • Overview of how Network Activation Call fits into ARPANET-H (Amy Lin, Lead of Health Innovation Network | ARPA-H Project Accelerator Transition Innovation Office (PATIO))
  • ACTR Overview (Brian Anderson, MD, Senior Advisor for Clinical Trial Innovation, ARPA-H)
  • Open Q&A Forum

Registration for the webinar is required here: https://ati.zoomgov.com/webinar/register/WN_kCvFpD1PRNKAfea_M13rsA#/registration