The Room Where It Happens: Why Operators Must Engage in Federal Policy

There is a version of the conversation about U.S. clinical trial competitiveness that leaves out the most important variable. It talks about regulatory timelines, IND pathways, and AI algorithms. It asks whether we have enough beds. It calculates our trial volume against Australia or China and sounds the alarm.

What it rarely talks about is the coordinator sitting at her desk at 7 p.m., reconciling three sponsor portals that each require the same document in a slightly different format, while a stack of patient queries waits.

That coordinator is where innovation either accelerates or stalls. And until the people who understand her daily reality show up in federal dockets, in Congressional offices, and in public comment periods, the policies that shape her work will be written by people who have never seen it.

This month, we at Florence Healthcare submitted public comments on three separate regulatory opportunities. I want to tell you what we said, why it matters, and why your voice belongs in these conversations too.

Capacity is not a bed count problem

Rep. Jake Auchincloss has been working on legislation to expand U.S. clinical trial site capacity. The goal is unambiguously right. The approach, as drafted, has a structural problem: it measures site capacity using inpatient bed count.

A site can have a full census of inpatient beds and still be completely unable to absorb additional trial volume. Those are different variables.

The majority of Phase I visits are ambulatory. No bed is involved. More critically, the constraint on site capacity is not square footage or mattresses. It is coordinator bandwidth.

Every trial added to a site’s portfolio carries with it a fixed administrative load: regulatory document management, sponsor correspondence, data entry and query resolution, IRB submissions, adverse event reporting, and protocol deviation tracking. That work does not scale with clinical staff ratios. It scales with research-specific workforce and the systems those coordinators use.

Our 2026 State of the Industry data makes this concrete: 95% of research sites still rely on email as their primary mechanism for document exchange. 64% report that sponsor-provided technology duplicates workflows they already manage in their own systems. These numbers do not describe a technology adoption failure. They describe a fragmented infrastructure environment in which sites absorb the coordination costs of every sponsor’s preferred system, in parallel, with no relief.

We also pushed back on a conflation that shows up repeatedly in policy discussions: floor nurses and research nurses are not interchangeable. Research coordinators require GCP training, protocol-specific expertise, regulatory documentation skills, and adverse event reporting knowledge. A site that redirects general clinical staffing toward research does not thereby gain research capacity. It gains confusion.

Our policy recommendation to Rep. Auchincloss’s office: measure site capacity using research-specific workforce metrics and administrative infrastructure readiness. And if the legislation creates digital infrastructure standards for interoperability, make sure those standards require sponsor technology to conform to site-level systems, not only the reverse. The data burden in clinical research flows from sponsors to sites. Standards that address only the agency-to-sponsor interface will not touch the actual bottleneck.

AI policy without site infrastructure is a floor with no foundation

The FDA issued an RFI on AI-Enabled Optimization of Early Phase Clinical Trials. We responded. The RFI asks the right questions about where AI can improve trial efficiency, and there is real potential here. Our concern was about the architecture of who participates.

The pilot program will establish a network of Qualified Research Institutions to partner with sponsors in reviewing IND submissions for first-in-human trials. The QRI model presents a structural risk we have flagged in other contexts: when implementation vehicles are scoped to the most well-resourced institutions, the evidence they generate is only valid within optimal conditions.

Validating AI performance at digitally mature academic medical centers and calling the results generalizable is like testing a new vehicle on a closed track and calling it a road test.

Community-based sites, independent research sites, and health-system-embedded practices serve the majority of U.S. patients. They operate in environments with varying levels of digital maturity, fewer dedicated research infrastructure resources, and significant variation in sponsor system requirements. If the pilot excludes them, the findings will not translate to the settings where the capacity opportunity is actually largest.

We also made the case that many early-phase delays are operational rather than algorithmic. AI-enabled approaches must be assessed in parallel with non-AI operational improvements: streamlined startup, standardized contracting, and site-level workflow automation. AI is an amplifier. It amplifies whatever is beneath it. A fragmented, manual operational environment amplified by AI is still fragmented and manual, just faster at some of the wrong things.

Our recommendation: design the pilot to accommodate varying levels of digital maturity from the outset. Include community-based and independent sites in the follow-on phases so that findings are actually generalizable. And evaluate AI performance against operational baselines that account for the full scope of trial execution, not just the regulatory review process.

Science funded on merit should not be defunded on politics

The Office of Management and Budget issued a proposed rule on Federal Financial Assistance that would introduce senior appointee review of research awards for consistency with Presidential policy priorities, and allow post-award termination when agency priorities shift.

We opposed it. Not as an abstract political position, but because we understand what the clinical research ecosystem actually depends on.

Biomedical research is a long pipeline. The work that eventually produces a clinical trial began years earlier in a laboratory that was funded on the basis of scientific merit. When you introduce political review into that funding process, you do not just create administrative friction. You change the incentive structure for investigators. Researchers who believe their work might be terminated based on shifting policy preferences will make more conservative choices. They will pursue less ambitious hypotheses. They will avoid topics that are politically inconvenient even if they are scientifically significant. The research pipeline narrows before anyone in clinical operations ever sees it.

The downstream impact reaches every part of the ecosystem Florence operates in. Academic medical centers cannot plan staffing and infrastructure around funding they cannot count on. Pharma and biotech sponsors depend on federally supported foundational research to validate targets and generate early-stage evidence. The U.S. clinical research enterprise is globally competitive in part because it sits on top of a world-class basic and translational research infrastructure. That infrastructure depends on funding predictability.

Political accountability over federal spending is important. It should not be achieved by replacing scientific merit with political preference.

Our recommendations to OMB: preserve independent peer review as the primary basis for awarding federal research funding; limit post-award termination authority to clear cases of noncompliance, misuse of funds, or ethical violations; and remove vague standards like national interest that can mean different things across administrations.

Now it is your turn: Operation TrialBlazer

HHS released Operation TrialBlazer, a roadmap to maintain U.S. leadership in early clinical research and development. It is one of the most substantive federal documents on clinical trial infrastructure in recent memory, and it explicitly invites stakeholder input.

HHS is hosting a public roundtable series and has opened a feedback docket on IND reform, IRB processes, site contracting, participant access, and regulatory uncertainty around payment. These are not abstract policy questions. They are the operational realities that clinical research professionals navigate every day.

If you work in this ecosystem, you have standing to comment. Site operators, sponsors, CROs, coordinators, investigators, health system research leaders: your operational experience is exactly the kind of evidence that should be in this record. The roundtables exist precisely because federal agencies know they cannot write effective policy without input from the people who execute trials.

The gap between good policy intent and operational reality does not close on its own. It closes when the people who understand the reality show up and describe it.

Submit your comments on Operation TrialBlazer here.

The comment period is not a formality

I have spent my career working within and alongside research site infrastructure. At NCI, at NIH, at NCATS, and now at Florence, where we support over 65,000 research sites and process more than 10 million operational workflows per month, I have watched good intentions produce bad policy because the people writing the rules did not have access to the people executing them.

Public comment periods exist to fix that. They are the mechanism through which operational expertise enters federal rulemaking. They are how the coordinator at her desk at 7 p.m. gets a seat at the table, even if she cannot travel to Washington.

We at Florence will keep showing up in these processes. We will keep filing comments, briefing Hill staff, and making the case that site infrastructure is not a downstream implementation detail. It is the precondition for every other innovation the field is trying to achieve.

We hope you will join us in The League and in the dockets. The room where it happens has more seats than people realize, and right now several of them are empty.

Join the League Today

Catherine Gregor is Chief Clinical Trial Officer at Florence Healthcare, the Vice Chair of ACRP Board of Directors, and the Chair of the Public Policy Committee for the ACRO Board of Directors. Florence supports over 65,000 research sites and processes more than 10 million operational workflows per month.