For decades, the United States assumed its scientific preeminence made it the natural home for early drug development — an assumption that quietly eroded as China, Australia, and Europe built faster, leaner systems for testing new medicines. The FDA's Operation TrialBlazer represents a formal reckoning with that loss, introducing rolling submissions and consultative pathways to reclaim ground in first-in-human research. Yet the deeper lesson emerging from this effort is one familiar to any institution confronting decline: the most visible authority is rarely the sole source of the problem, and
FDA's TrialBlazer aims to speed early trials, but experts warn bigger hurdles remain
Until we take care of the site issues, we're getting nowhere.
Mark
Why is the FDA's streamlining of IND applications not enough on its own?
Mimi
Because the FDA is only one gate in a much longer process. A company still has to activate trial sites, get institutional review boards to approve the protocol, and enroll patients. Those steps often take longer than FDA review itself.
Mark
So China is faster because it has fewer regulatory hurdles?
Mimi
Partly, but also because they use pathways that bypass some of their own regulatory center entirely—investigator-initiated trials, for instance. We can't match that speed without fundamentally changing how we do oversight. The question is whether we can get close enough to be competitive.
Mark
What's the single IRB model supposed to fix?
Mimi
Right now, if you're running a trial at ten different hospitals, each hospital's IRB reviews the same protocol independently. That's ten separate reviews, ten separate approval timelines, ten separate conversations. A single IRB of record means one review, one approval, one timeline.
Mark
That sounds obviously better. Why hasn't it happened already?
Mimi
Because IRBs don't want to give up their authority. They see themselves as protecting their institution's interests and their own oversight role. Requiring them to defer to a central IRB feels like a loss of control, even if it's more efficient.
Mark
Is the FDA itself part of the problem?
Mimi
According to people who've worked there, yes—not because the agency is hostile, but because many FDA reviewers have never developed a drug in industry. They tend to review protocols line-by-line, requesting changes that go beyond what's necessary for patient safety. It's a cultural gap.
Mark
What would actually move the needle?
Mimi
Probably a combination: streamlined FDA processes, centralized IRB review, and a shift in FDA culture toward trusting experienced drug developers more. But that last part requires changing how people think about their role, which is slower than writing new rules.
O Pulso
- China has overtaken the United States in early-phase clinical research volume, approving more cancer drugs than the FDA between 2020 and 2025 and drawing trial sponsors away with faster timelines and lower costs.
- The FDA's TrialBlazer pilot introduces rolling IND submissions and more frequent sponsor consultations, directly targeting the agency's own procedural rigidity as a competitive liability.
- Former FDA insiders warn that the real chokepoints — slow site activation, duplicative institutional review board processes, and administrative overreach — lie beyond the FDA's direct authority and will not yield to regulatory reform alone.
- A proposed single-IRB model could compress trial activation by six to twelve months, but academic institutions and healthcare systems are resisting the loss of their independent oversight roles.
- With public comment periods running through September and roughly 2,000 FDA staffers newly confronted with data on the offshore migration of trials, the agency is attempting to build internal urgency to match its external ambition.
For decades, the United States assumed its scientific preeminence made it the natural home for early drug development — an assumption that quietly eroded as China, Australia, and Europe built faster, leaner systems for testing new medicines. The FDA's Operation TrialBlazer represents a formal reckoning with that loss, introducing rolling submissions and consultative pathways to reclaim ground in first-in-human research. Yet the deeper lesson emerging from this effort is one familiar to any institution confronting decline: the most visible authority is rarely the sole source of the problem, and reform at the top cannot substitute for transformation throughout the system.
The United States is losing its dominance in early-stage drug trials. China conducted less than 8 percent of global clinical research in 2010; by 2020 it had surpassed America entirely, approving 94 cancer drugs between 2020 and 2025 to the FDA's 87. Sponsors increasingly run Phase 1 studies in Australia, Spain, or China — drawn by speed, lower costs, and fewer administrative obstacles.
In June, the Department of Health and Human Services launched Operation TrialBlazer to reverse this trend. The FDA's contribution centers on the investigational new drug application process: rolling submissions that allow incremental feedback, rewritten guidance clarifying what Phase 1 trials actually require, and more consultative access to regulators before a formal application is filed. Acting CDER Director Karim Mikhail acknowledged the current system's bluntness — sponsors get a single pre-IND meeting to ask every question they have, a pressure that falls hardest on smaller companies with limited regulatory experience.
But experts who have worked inside the FDA are clear-eyed about the limits of these reforms. Harpreet Singh, a former FDA oncology division director now at Precision for Medicine, argues that the agency is not the primary source of delay — site activation, IRB approvals, and patient enrollment infrastructure are. His teams often choose Australia or Europe not for regulatory reasons but because those locations simply move faster on the ground. Former FDA chief medical officer Hilary Marston echoed the point: without fixing site-level dysfunction, the upstream reforms will not deliver the promised acceleration.
TrialBlazer does reach toward those downstream problems. The FDA is advancing a single institutional review board model — one IRB of record for multisite trials rather than each institution conducting its own independent review. Saol Therapeutics CEO Dave Penake estimates this change alone could cut activation timelines by six to twelve months. The obstacle is institutional: IRBs housed within academic medical centers are reluctant to surrender oversight they consider integral to protecting their own patients and staff.
Singh also raised a subtler cultural concern — that FDA reviewers, many of whom lack industry development experience, have drifted toward line-item protocol management rather than the narrower mandate of confirming it is safe to proceed. Whether TrialBlazer can address that disposition alongside its structural reforms remains an open question. Public comment periods extend through September, and agency leadership has already held internal sessions to confront staff with the scale of the offshore migration. The debate has moved past whether America has a problem. The harder question now is whether the institutions responsible for solving it can move faster than the trend they are trying to reverse.
The United States is losing the race to run early-stage drug trials. In 2010, China conducted less than 8 percent of the world's clinical research. By 2020, it had overtaken America entirely. The numbers tell a stark story: between 2020 and 2025, China's regulators approved 94 cancer drugs while the FDA approved 87. Companies developing new medicines increasingly choose to test them elsewhere—in Australia, Spain, or China—because those countries move faster, cost less, and demand fewer administrative hoops.
The Health and Human Services Department announced Operation TrialBlazer in June to reverse this trend. The initiative, which includes a new FDA pilot program, aims to compress the timeline from drug discovery to first-in-human trials by as much as a year. The goal is straightforward: make America the obvious choice for running early-phase studies again. Health Secretary Robert F. Kennedy Jr. framed it plainly: "America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas."
The FDA's piece of this effort focuses on the investigational new drug application process itself. The agency is introducing rolling submissions, allowing companies to submit IND applications in pieces and receive feedback incrementally rather than all at once. It is also rewriting its guidance documents to clarify what information is actually necessary for Phase 1 trials—a distinction that current guidelines, written for later-stage studies, do not adequately address. Acting Center for Biologics Evaluation and Research Director Karim Mikhail acknowledged the problem bluntly: the FDA currently allows sponsors only a single pre-IND meeting with regulators to ask questions before submitting their formal application. "You have this one chance, and one chance only, to be in front of the FDA with all your questions," he said. "That's a very big, honestly tough position for a CEO." The agency is working to break that mold, offering more consultative touchpoints before an application lands on a reviewer's desk.
But here is where the optimism hits a wall. Harpreet Singh, who spent years as a division director of oncology at the FDA and now serves as chief medical officer at the global contract research organization Precision for Medicine, offered a sobering assessment: the FDA is not actually the primary source of delays in early-phase trials. The real bottlenecks sit elsewhere—at the trial sites themselves, in the institutional review boards that must approve protocols, and in the byzantine process of activating sites and enrolling patients. When Singh's team places early-phase trials, they often choose Australia or Europe not because of FDA paperwork but because those locations offer faster site activation, lower costs, better infrastructure, and smoother IRB processes. "Until we take care of the site issues, we're getting nowhere," agreed Hilary Marston, a former FDA chief medical officer now at Canal Row Advisors.
The TrialBlazer roadmap does acknowledge these downstream obstacles. The FDA is exploring a single institutional review board model—one IRB of record for all sites in a multisite trial rather than each site conducting its own independent review. This could eliminate months of duplicative paperwork. Saol Therapeutics CEO Dave Penake estimated that centralizing IRB review alone could shave 6 to 12 months off trial activation timelines. The FDA proposed this requirement in 2022 and TrialBlazer appears designed to move it forward. Yet even this faces resistance. IRBs, typically housed within academic institutions or healthcare systems, are reluctant to cede their institutional authority. As Heidi Gertner, a partner at Hogan Lovells, noted: "Usually, IRBs don't really want to give up their oversight, because it involves their institution, employees and processes."
Singh raised another concern about the FDA's own culture. Many agency physicians have never worked in industry developing drugs, while most biotech and pharma professionals have substantial development experience. Yet the FDA often line-item reviews and edits every detail of protocols—going, in Singh's view, beyond what is necessary to ensure patient safety. The purpose of an IND approval is to confirm it is safe to proceed. But the scope of FDA commentary increasingly extends into territory that feels more like micromanagement than risk mitigation.
The FDA is taking this seriously. Acting Center for Drug Evaluation and Research Director Michael Davis emphasized that TrialBlazer is a whole-of-HHS effort, involving the NIH's translational sciences center and the National Cancer Institute alongside FDA divisions. The agency held an internal town hall where leadership presented data on how clinical trial phases are migrating overseas to roughly 2,000 staffers. Davis said many did not fully appreciate the scope of the problem until they saw the numbers. The public comment period for the IND initiative closed July 22, with other TrialBlazer programs remaining open for feedback through August and September. Whether these reforms will be enough to reverse the tide remains uncertain. But the conversation has shifted from whether America has a problem to how quickly it can solve it.
Citações Notáveis
The FDA is not the primary source of most delays in early phase clinical trials. The major delays instead occur at the site level.— Harpreet Singh, former FDA division director of oncology
America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas.— Health Secretary Robert F. Kennedy Jr.
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