As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient Access

A conversation between Milken Institute Senior Director of FasterCures Kristin Schneeman and Clinical Leader Executive Editor Abby Proch

Clinical research in the U.S. remains concentrated at a small number of large academic medical centers, leaving many patients with few opportunities to participate. Meanwhile, enrollment challenges continue to delay or derail trials, and the nation's share of global trial activity is slipping as other countries build research capacity.

A new action plan, “Enabling Access to Clinical Research: An Action Plan for Policy and Practice Change,” argues that many barriers to broader access aren't required by law or regulation but stem from overly conservative, even outdated, practices. The plan was developed by the Enabling Networks of Research Infrastructure for Community Health through Clinical Trials (ENRICH-CT), a FasterCures-led coalition. Its paper outlines eight priority areas — including modernizing informed consent and removing financial barriers — and assigns concrete actions to stakeholders across the clinical research ecosystem, including policymakers.

In this Q&A, Kristin Schneeman, senior director at the Milken Institute's FasterCures, explains how the coalition chose its priorities, where members debated most, what sponsors and CROs should start and stop doing, and the one policy change she would like to see most.

Clinical Leader: What do we know about research access in the U.S. today, and how does this action plan intend to improve it?

Kristin Schneeman: Clinical research in the United States is highly concentrated; the vast majority of trials are conducted at a small number of large academic medical centers, which means most Americans, particularly those in rural areas and underserved communities, have little or no access to research participation.

At the same time, more than 80% of trials are delayed or fail due to enrollment challenges, suggesting that the current system isn't working well even for the sites and sponsors it was designed to serve. What ENRICH-CT found, and what this paper documents, is that many of the barriers to broader access aren't required by law or regulation — they're the product of overly conservative practice, cultural inertia, and policies that haven't kept pace with available technology. The action plan identifies specific, practical changes that federal agencies, Congress, institutional review boards (IRBs), and private-sector organizations can make to open research to more patients, more sites, and more of the country.

What's at risk if the clinical research industry doesn't invest — interest, time, resources — in improved patient access, especially as compared with other countries?

The competitive risk is real and immediate: The United States' share of global clinical trial activity has been declining for years as China, India, and other countries build research capacity faster than we are expanding ours. But the domestic cost may be even more consequential; when clinical research happens primarily at elite academic centers and without systematic or meaningful involvement of patients, the evidence shows that trials recruit slowly or not at all, and the people who do participate are not representative of all those in need of the treatments. This is an enormous waste of time, resources, and potential progress for patients. The ENRICH-CT paper is premised on the idea that expanding access and improving efficiency are not competing goals — the same changes that open research to more people also make trials faster and less costly to operate.

What are the action plan’s eight priority areas, and why were they chosen?

The eight areas fall into two clusters: four focused on making trials more patient-centered — designing more inclusive studies, modernizing informed consent, removing financial barriers to participation, and returning results to participants — and four focused on embedding research more deeply in routine care — embracing pragmatic trial designs, streamlining data collection, making EHRs work for research, and leveraging decentralized and digital technologies. They were chosen not because they're the only issues that matter, but because they represent the highest-leverage intersection of feasibility and impact: areas where meaningful change is practically achievable, where existing policy authority is being underutilized, and where a coalition of 90+ organizations could bring enough credibility and momentum to move the needle. Each area had been the subject of years of prior work; what this paper tries to do is move from diagnosis to a concrete, actor-specific plan for action.

What aspect of the plan was a "no-brainer" for everyone involved, and where was there the most debate?

The group easily aligned on the core value of ensuring all our research and recommendations focused on improving participant experience and broadening access, from the planning stages of research to the return of study results. There was broad consensus around informed consent modernization, including that eConsent should be the expected default rather than the exception, with paper consent available as an accommodation for individual participant need. The technology exists, the regulatory authority exists, and the continued default to paper is hard to justify on any grounds other than inertia.

There was more vigorous conversation about eligibility criteria: specifically, how much burden to place on researchers and sponsors to justify exclusions using real-world data, and how to handle legitimate safety-based restrictions, particularly in earlier-phase trials, without creating a new compliance burden that inadvertently slows research. The group landed on a framework that requires documented, evidence-based justification for exclusions rather than mandating specific inclusion thresholds, which preserves scientific judgment while making the default assumption one of inclusion rather than exclusion.

What didn't make the plan but could have, and is it on ENRICH-CT's radar for future work?

We prioritized looking at ways to make trials more patient-centered and embedded in care because we felt they represented the highest-impact actions in the near and long term. In addition to those two pillars, however, we identified two other pillars of the vision for a streamlined, accessible clinical research system: making research more available to people via nontraditional institutions and by streamlining trial conduct, and making trials more tech-enabled and data exchange more fluid while centering participant privacy. The scope of this paper was already very broad, and we wanted to give every issue the attention it deserves. It’s entirely possible we will continue our work on those other two pillars.

How can sponsors and CROs help? What should they start — or stop — doing today?

We highlight in the report a number of actions we are already empowered to take, as well as practices that are not required and are holding us back. We can start using real-world data to design more inclusive trials; simplifying and modernizing informed consent; compensating and reimbursing participants and providers fairly; returning study results to participants; embracing pragmatic trial designs and streamlining data collection; and deploying decentralized trial elements and digital health technologies.

We can stop defaulting to overly restrictive eligibility criteria; producing legalistic, maximalist consent documents; treating fair participant compensation as “undue inducement”; “collecting everything” in terms of what data is needed for a trial; overlooking IRBs’ roles as agents of inclusivity; and reverting to traditional trial designs that minimize decentralized and pragmatic approaches out of habit or risk aversion. 

What are regulators' and policymakers' roles? If you could fast-track one policy change, which would it be?

The FDA has significant authority it hasn't fully exercised: Existing guidance on decentralized trials, real-world data, and electronic consent hasn't been consistently translated into review division practice, and that gap between what guidance permits and what reviewers expect is one of the most concrete barriers sponsors and sites face. If we could fast-track one change, it might be the FDA issuing clear, evidence-based risk-level definitions for pragmatic trial designs — because risk classification determines consent waiver eligibility, monitoring requirements, and a host of other downstream obligations, and without that clarity, IRBs default to the most conservative interpretation of every study design. That one clarification could unlock a significant range of research that is technically permissible but practically stalled.

What are ENRICH-CT's next steps, and how can readers and their organizations get involved?

ENRICH-CT's immediate priorities are engaging the policymakers and agencies whose action this paper calls for to brief them on its findings, offer whatever support we can in their work, and offer the coalition as a resource and sounding board. There is enormous energy right now around preserving U.S. competitiveness in biomedical innovation and the role of clinical trials in that, and we want to be responsive to and leverage this moment for the benefit of patients and the enterprise. We're certainly tracking the PDUFA reauthorization process closely, as well as the evolution of the administration’s Operation TrialBlazer and the Faster Clinical Trials Act. Organizations that want to engage can do so by joining ENRICH-CT, by submitting public comment when relevant opportunities open, or by reaching out to FasterCures directly.

About The Expert:

Kristin Schneeman is senior director of FasterCures at the Milken Institute, where she oversees most policy and programmatic activities, focused on improving the research and development environment, engaging patients in research and health, and accelerating innovation. Among other initiatives, she leads The Research Acceleration and Innovation Network program, which provides a platform for knowledge sharing and relationship building to support the growth of venture philanthropy in medical research.

Schneeman has more than 30 years' experience in public policy, politics, academia, and the media. She served as a senior adviser and policy director to a gubernatorial candidate in Massachusetts, as a policy aide to a U.S. Congressman, and as the front-line manager and chief-of-staff for a senior adviser to Vice President Al Gore. At Harvard University, she directed research projects on future challenges facing governments and on complex negotiations in business, politics, and international relations. Schneeman began her career as a producer of documentary films, for which she was the recipient of an Emmy Award in 1990.