A letter from The Coalition:

Advancing Clinical Trials at the Point-of-Care: Building a Platform to Give Patients and Clinicians Needed Evidence for Better Care

Today, we are announcing a new collaboration to help our patients and enable our clinicians to access the evidence they need to deliver the best care. The Advancing Clinical Trials at the Point-of-Care coalition (ACT@POC™) is bringing together health systems, community-based care organizations, health research organizations, and other collaborators to support the design and conduct of adaptable and responsive clinical trials focused on increasing participation, improving patient access, and facilitating development of targeted therapies with important impact on patient outcomes.

The Coalition Objectives

As it works to build a more inclusive and effective clinical trial enterprise, the Coalition will be guided by the following objectives—

  • Engage clinicians in a broader range of care settings, to obtain much greater clinical trial participation so research will reflect large and diverse patient populations who are not typically able to participate in clinical research
  • Develop and adopt effective data collection tools that enable straightforward data collection from electronic data systems used to support and improve routine clinical care, to limit the burdens and maximize the benefits for community healthcare providers, who must carve out time during the provision of care to collect data
  • Collaborate with clinical trial design leaders, regulators, funders, and other stakeholders to assure that clinical trial design features are fit for purpose – with simpler design and data collection requirements for products where mechanisms and safety issues are better understood
  • Enroll diverse trial participants by broader participation in effective community trials, to improve evidence from communities of color which, due to systemic racism and other barriers in access to care, are often disproportionately impacted by chronic and acute disease and underrepresented in research
  • Address unmet medical needs by reaching a critical mass of participation in existing and new clinical trials to enable meaningful, large-scale trials that maximize learning from patient participation and minimize burden on participating hospitals, clinicians, and patients while collecting reliable data
  • Improve technology supports and capabilities to conduct such studies over time, enabling increasingly sophisticated yet nonburdensome clinical trials and supporting care improvement

Upcoming Action

1. Develop tools and supports to enhance participation of community health care providers and community health systems in clinical trials

  • Develop and implement digital tools to enable more automated and straightforward data collection, consent, and enrollment, including an adaptable common data model that can collect data from widely used electronic medical record platforms and other data sources. The MITRE Corporation is strongly committed to building on their work in cancer, COVID-19, and other areas to assist with applying such electronic tools to simplify participation.
  • Partner with precompetitive collaborations such as the Clinical Trials Transformation Initiative, Transcelerate, and the FDA-CPATH CURE Drug Repurposing Collaborative to identify and improve trial site resources that support trial execution.
  • Develop site readiness assessment resources to make it easier for health care providers to assess what’s needed to participate in key trials (e.g., EHR interoperability, staffing, training, and pharmacy capacity as well as legal and financial review capacity).
  • Identify partner organizations to expedite trial-site contracting and participation.

2. Identify, partner, and enhance promising clinical trial networks for practical trials in key clinical areas

  • Engage leading potential clinical trial and platform partners to determine feasibility and funding for the ACT@POC™ initial trial activities, focusing on opportunities for greatest impact through study designs that can be implemented widely. These could include: i) Future pandemic preparedness (including an inpatient or outpatient practical respiratory trial network such as REMAP-CAP, or the network envisioned in the Federal government’s future preparedness planning); ii) FDA’s CURE platform for COVID-19 response and potentially other chronic disease studies; iii) PCORNet’s practical platform for cardiovascular studies and simple chronic drug trials (e.g., the PREVENTABLE study of the impact of lipids on certain cardiovascular outcomes and dementia onset); iv) anticipated practical platform trial interest in post-market randomized studies of treatments to delay progression of Alzheimer’s disease); or other networks that could be expanded. We expect some implementation partnerships to support many of these efforts.
  • Partner with the most promising existing and emerging research networks identified in this trial network assessment.
  • Support the development and implementation of consistent platform trial features that can be used for multiple priority diseases.

3. Improve coordination across existing trials and networks in the priority areas, limiting the need for new networks

  • Partner with FDA as well as public and industry sponsors of research to assess priority research questions and data needs; match these needs with existing network availability and capacity.
  • Promote efficient regulatory oversight of trials, by engaging with regulators, funders, and other stakeholders to identify opportunities to reduce participation burdens resulting from regulatory compliance requirements while maintaining trial integrity and appropriate research protections.
  • Support the development of common trial design and data collection features that enable co-enrollment across multi-arm platform trials assessing multiple therapeutics.

4. Implement culture change in partner health systems to increase network participation

  • Partner with community-based health care providers to understand clinician and patient motivation and needs for trial participation.
  • Partner with the federal government and payers to refine supports for participation in meaningful trials (e.g., building on quality bonus payments for COVID-19 trial participation and other improvement incentives).
  • Partner with payers and health system CEOs to develop plan for incentivizing adoption of electronic tools that can ease participation, reduce burden, and improve quality of evidence.
  • Encourage industry participation in trial networks

Upcoming Deliverables

  1. Tools and resources to reduce burden of participation (e.g., automated data collection tools, site readiness and onboarding toolkit, best practice models, policies, and guidelines).
  2. Recommendations and proposals for achieving broad participation by community providers in clinical trial networks and/or platforms to develop practical evidence that addresses key priority areas of unmet medical need (e.g., COVID-19/public health emergencies and high-burden chronic diseases).
  3. A specific goal for increased health system participation in one or more clinical trial networks or platforms, alongside a parallel goal for increased participation of smaller and more diverse community health care providers.

Participating Organizations

ACT@POC™ includes health systems, community-based care organizations, health research organizations, and other collaborators to drive the implementation of much more widely available and representative clinical trial networks to support rapid evidence development.

  • Ascension
  • Clinical Trials Transformation Initiative
  • CURE Drug Repurposing Collaboratory (C-Path + NCATS + FDA)
  • Duke Margolis Center for Health Policy
  • Duke University Health System
  • Emory-Morningside Center for Innovative and Affordable Medicine
  • Intermountain Healthcare
  • Medable
  • Mayo Clinic
  • Quantum Leap Healthcare Collaborative
  • The Broad Institute
  • UMass Med
  • University of California Irvine
  • University of California San Francisco
  • Vanderbilt University Medical Center

The Coalition also seeks out the inclusion of patient groups, community hospitals and health centers, medical practices, research organizations, and biotechnology companies to identify a practical agenda and action steps to substantially augment the evidence generation capacity of the current clinical trial enterprise.