Why Cutting Trial Red Tape Won't Fix Clinical Trial Design

The FDA is moving on 2 fronts that, on paper, pull in opposite directions. The agency is under pressure from congressional Republicans to keep enforcing clinical trial diversity requirements, even as it races to cut months off phase 1 timelines and rewrite direct-to-consumer (DTC) advertising rules. For Francisco Beca, MD, PhD, chief medical officer at QuantHealth and a former clinical development leader at Merck and Seagen, that tension is less fundamental than it appears, and the fix lies less in policy language than in how trials are simulated before a patient is ever enrolled. Oyepeju Abioye, MD, MSc, a third-year internal medicine resident at Allegheny Health Network who studies clinical trial readability, adds a patient-facing view: even a well-designed trial fails to generate representative data if patients can't understand or access it.

Diversity Reframed as a Data Problem, Not a Political One

After the Trump administration spent the past year stripping diversity, equity, and inclusion (DEI) language from FDA guidance, congressional Republicans have taken a different tack in the agency's most recent funding bill: pushing the FDA to continue implementing diversity action plan requirements for late-stage trials while explicitly distancing the effort from DEI framing.¹ The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2027 House-passed bill (HR 8646) was accompanied by a report instructing the FDA to keep enforcing a law requiring sponsors to submit diversification plans, even as the broader administration has treated DEI as a target for rollback.

That removal was not isolated. In January 2025, the FDA quietly took down draft guidance on clinical trial diversity from its website days after President Donald Trump signed an executive order curtailing DEI programs, without public notice or explanation.² The draft, issued in June 2024, would have required sponsors to submit Diversity Action Plans detailing enrollment goals disaggregated by race, ethnicity, sex, and age. Final guidance had been legally due by June 2025; its removal left sponsors uncertain how the FDA would evaluate those plans, even though the underlying statute still requires them once finalized.

The guidance page was later restored, although not unchanged: after a February 2025 court order requiring agencies to reinstate removed government websites, it reappeared carrying a disclaimer disputing “gender ideology,” tied to a separate executive order.³ Former FDA Commissioner Martin Makary, MD, MPH, later defended trial diversity on practical grounds: “I believe in common sense, and I believe in clinical trial diversity…so I believe if you're going to [extrapolate] results to the general population, you should have results in those populations [for which] you're making recommendations.” Whether that stance produces finalized guidance remains unresolved.

In an interview with The American Journal of Managed Care^®, Beca said that distinction is not just rhetorical positioning; it reflects a real methodological issue. "Diversity and real-world data are actually 2 sides of the same coin," he said. "If the trial doesn't mirror the real-world demographics, your safety and efficacy data are incomplete." A trial lacking sufficient demographic, genomic, or comorbidity diversity is not merely a representation problem, he explained, but a data gap that undermines the science itself.

That gap has downstream consequences, Beca said, because payers and clinicians end up making prescribing and reimbursement decisions based on "hypersterilized, nonrepresentative trial cohorts." Given how demographically diverse the US population is, he argued trial representativeness is better understood as a data science issue than a political one.

Readability and Access Barriers Compound the Data Gap

Beca's argument that diversity is fundamentally a data problem has a corollary for patient-facing work. Abioye, who founded Protocol & People, a public initiative that translates clinical trial concepts into plain language, said one of the most fixable barriers to enrollment sits in a document nearly every participant encounters: the informed consent form. "I want to be able to look at this as a patient would," she said. "If an average individual doesn't fully understand what is in that document, they might not even be able to fully explain that to their oncologist as the reason why they're not willing to participate."

Readability is only one of several barriers keeping underserved patients out of trials, Abioye said, and they tend to compound one another. Time away from work, transportation, and restrictive eligibility criteria all factor in, and patients who can't take paid time off are often the same patients facing the greatest transportation and cost burdens. "It's like a ripple effect," she said.

The consequences extend beyond the US. Abioye added that thinner research infrastructure across sub-Saharan Africa means fewer trials and fewer opportunities to build the genomic datasets diverse enrollment is meant to produce. "We don't have enough Black people in trials here in the US," she said. "What that means is we don't have enough genomic data to be able to come to much more robust conclusions." Expanding US trials to sites in Africa led by local investigators, she said, would strengthen data quality "for the entire world."

A Faster Phase 1 Won't Fix a Flawed Trial

The FDA's Operation TrialBlazer initiative, part of a broader HHS effort to keep early-stage drug development in the US rather than losing it to China and Australia, aims to shave 6 to 12 months off phase 1 timelines through an expedited investigational new drug pilot; revised chemistry, manufacturing, and controls (CMC) guidance; and a centralized resource hub for sponsors.^4,5 The FDA has framed the changes as reducing regulatory burden without lowering scientific standards.⁵

Beca welcomed the clarifications, particularly around CMC requirements that he said had previously "been missing" and left sponsors "in circles." But he was blunt about the limits of streamlining alone. "Regulatory speed does not equate [to] scientific success," he said. "If you speed up a clinical trial that is set to be a failure, you're just going to fail faster instead of really changing the outcomes."

Given that a full clinical development program typically takes 9 to 13 years, Beca said shaving off 6 months is "a start" but won't meaningfully change overall timelines. The more consequential shift, in his view, would be a regulatory overhaul that incorporates clinical trial simulation into both early- and late-stage development. He noted the FDA has already solicited public comment on the use of artificial intelligence in early-stage development, which he hopes will lead to formal guidance.

What a Real Phase 1 Overhaul Would Look Like

Asked what a genuine overhaul of phase 1 protocol design would involve, Beca described a shift toward assumptions "pressure tested on in silico simulations" before trials begin. He pointed to the persistently high failure rates in drug development, commonly cited as roughly 90% overall and 40% to 60% at phase 3, as the real target for improvement. "If we can speed up the process and at the same time increase our hit rate, I think that could be transformative," he said.

Speed and Representation No Longer Have to Trade Off

Historically, sponsors faced a binary choice: enroll quickly by concentrating trial sites in a narrow set of countries, sacrificing representativeness, or prioritize diversity at the cost of speed. Beca said clinical trial simulation is beginning to dissolve that trade-off, modeling how a drug would perform across real-world US demographics before enrollment opens, including how inclusion-exclusion criteria affect outcomes across different population compositions. "I think this opens doors for speed and representation to go hand in hand," he said.

Multimorbidity Is the Biggest Blind Spot

Asked where the gap is widest between the data sponsors collect and what clinicians actually need, Beca pointed to multimorbidity. Trials are designed around "hypersterilized single disease" populations to isolate a clear efficacy and safety signal, he said, but clinicians and payers manage real-world patients with overlapping conditions and complex medication regimens. Simulation, he said, offers a way to test how factors such as renal function or specific comorbidities would affect outcomes without first exposing real patients to that uncertainty.

Abioye's work points to a related, more restrictive version of the same problem: eligibility criteria that simply exclude patients who don't fit a narrow protocol. "Some trials are not representative of actual real-world individuals in terms of age distribution, comorbidities, and all of that," she said.

Where Policy Proposals Fall Short

Beca was direct in assessing the current wave of proposals, saying they largely "tweak the administrative machinery," from review windows to DTC ad disclosures, without addressing the underlying science. Clinical trial simulation, he argued, can improve "the science flowing through those pipes" today by dynamically optimizing patient selection and dosing, identifying predictive biomarkers before sponsors commit significant capital, and pressure-testing eligibility criteria against multimorbid, real-world populations before enrollment.

Abioye, who has taken part in the American Society of Clinical Oncology's advocacy summits on Capitol Hill, pointed to a narrower, near-term fix: covering the ancillary costs of trial participation, including travel, lodging, and lost wages, and communicating that support to patients up front. "That would definitely help our patients who are underserved and who would benefit from these trials," she said.

References

1. Republicans push FDA to protect clinical trial diversity requirements. STAT News. July 6, 2026. Accessed July 28, 2026. https://www.statnews.com/2026/07/06/republican-lawmakers-attempt-clinical-trial-diversity-protection/

2. Grossi G. FDA quietly removes draft guidance on diversity in clinical trials following executive order on DEI. AJMC^®. January 31, 2025. Accessed July 29, 2026. https://www.ajmc.com/view/fda-quietly-removes-draft-guidance-on-diversity-in-clinical-trials-following-executive-order-on-dei

3. Caffrey M. Trump’s stance doesn’t end need for diversity in clinical trials. AJMC. April 11, 2025. Accessed July 29, 2026. https://www.ajmc.com/view/trump-s-stance-doesn-t-end-need-for-diversity-in-clinical-trials

4. Federal health agencies unveil plan to speed up Phase 1 clinical trials by 6 to 12 months. Fierce Biotech. June 2026. Accessed July 28, 2026. https://www.fiercebiotech.com/biotech/federal-health-agencies-announce-plan-speed-phase-1-clinical-trials-6-12-months

5. FDA actions to accelerate and modernize early and late-stage clinical development. FDA. June 22, 2026. Accessed July 28, 2026. https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development