Auchincloss bill would embed trials in routine care, speed FIH starts
Sweeping bipartisan trial reform proposal borrows from Australian fast-track model
Rep. Jake Auchincloss (D-Mass.) is engaged in an old-school endeavor, developing clinical trials modernization legislation that echoes the sweeping laws that have reshaped the U.S. biomedical landscape periodically in the decades following World War II.
It is old school in the scope of its aspirations, but also in the way it is being crafted.
Auchincloss is working with an influential Republican, Rep. Morgan Griffith (R-Va.), chair of the Energy & Commerce Committee’s health subcommittee, and with the Trump administration. He has also solicited ideas from a wide range of outside experts.
The centerpiece of the legislation is the Cures in Care Initiative, which would create a network of point-of-care clinical trial platforms, essentially turning hospitals and clinics into ongoing research sites rather than treating clinical trials as separate, standalone events.
To reduce the time required to launch Phase I trials, the proposal would establish pilot programs for third-party oversight of lower-risk first-in-human trials, modeled on Australia’s Clinical Trial Notification (CTN) scheme, which allows trials to begin faster under a streamlined review process.
Integrating research into routine clinical care would create the foundation for a learning health system.
The discussion draft says it is intended to “modernize the clinical development process.”
In fact, the proposal goes much further. Integrating research into routine clinical care would create the foundation for a learning health system. If the experiences of patients become inputs for evaluating the safety and efficacy of new medical interventions, they can also be used to assess outcomes more broadly.
Auchincloss envisions his legislation as dovetailing with Operation TrialBlazer, the Trump administration’s road map to making early clinical research more efficient.
“I want this to be a bipartisan, congressionally driven vehicle to codify the salutary parts of TrialBlazer, and I think it’s mostly salutary, and also to do the things that only Congress can do,” Auchincloss told BioCentury. “This is a broad bipartisan goal. We want better, faster, cheaper clinical trials.”
The first iteration of the legislation will be introduced this fall, Auchincloss told BioCentury. His plan is to reintroduce it early next year and develop the consensus that will be needed to have it included in the FDA user fee reauthorization legislation that must pass, or be extended, by Oct. 1, 2027, to avoid a collapse in FDA drug reviews.
Cures in care
The draft authorizes a pathway to scale point-of-care trial networks for diseases with significant unmet need. It sets a one-year deadline for identifying the initial networks and three years for broader adoption.
The Advanced Research Projects Agency for Health (ARPA H) and NIH would be directed to implement at least three lead platforms, addressing rare diseases, high-burden chronic diseases, and other unmet needs.
Selection criteria would emphasize feasibility for providers outside academic medical centers and for those serving high risk populations, along with participation by a critical mass of drug developers, a direct response to the complaint that trials cluster where the research infrastructure is rather than where patients are.
“We cannot be three times slower — that’s not acceptable.”
Rep. Jake Auchincloss
The draft would modernize IRB oversight, ethical conduct requirements, governance, and dissemination practices to make reusable trial platforms sustainable, and would align regulatory requirements for real-world research data with data and interoperability standards emerging from CMS and the Office of the National Coordinator for Health Information Technology.
It would accelerate validation of biomarkers and clinical outcome assessments that could reduce the cost and duration of point-of-care studies, and require those measures to be aligned with the ones already used in federal healthcare quality programs. It also would require an interagency implementation plan and a revision of FDA guidance covering cross-agency data modernization and the use of digital and AI tools in point-of-care trials.
The draft also calls for a collaborative to conduct rapid learning and evaluation across the platforms, and for best practices in training and technical support aimed at healthcare organizations with the least existing research capacity.
Because it is likely to be attached to user fee reauthorization legislation, funding for these activities could come from new user fees.
Keeping the U.S. in the game
Competition from China, where companies can conduct first in-human (FIH) trials at scale more rapidly, and at lower cost, has solidified political support for measures that could, and arguably should, have been taken years ago. China’s clinical trials advantage is helping to fuel a rush by Western companies to acquire drugs in China.
Auchincloss is realistic about the goals of streamlining FIH trials.
“We’ve got to be more affordable, but we’re not going to be cost competitive to China,” he said. “The core thing that has to get done with this bill over time is we’ve got to be faster. We cannot be three times slower — that’s not acceptable.”
The goal should not be to prevent sponsors from conducting trials, including FIH trials, outside the U.S., he said. “Sometimes China makes sense; sometimes Australia makes sense. What’s key is that you have optionality around that first-in-human data collection.”
Auchincloss added: “What’s not acceptable is for America to just not be one of those options because we are so much slower.”
Emulating Australia
The draft’s directive for FDA to establish pilot programs for oversight of lower-risk Phase I trials would require the agency to issue guidance for pre-certification of the third-party organizations that would implement an IND alternative pathway. This goes beyond FDA’s expedited IND pilot by testing whether the gating decision for low-risk FIH trials can move outside the agency.
The draft instructs HHS to assess changing the Common Rule on research protections to facilitate a clinical trials notification system. The Common Rule defines IRBs as bodies reviewing ethics, risk-benefit, informed consent, and subject protections. Changes may be needed to allow IRBs to make regulatory judgments about whether a product’s preclinical package supports FIH dosing.
Requiring U.S. data, regulating China’s access to U.S. markets
The Auchincloss proposal turns current law on accepting Chinese clinical data on its head. Today, FDA must accept foreign clinical data to support an IND or marketing application provided the study was GCP-compliant and FDA can validate it through inspection. Auchincloss wants to establish a “requirement for clinical data to be collected in the U.S., with exceptions reviewed by the HHS Secretary for GCP compliance and applicability of the data to the U.S. healthcare system.”
While he wants the default assumption to include U.S. clinical data, Auchincloss does not support a proposal the House Appropriations Committee has endorsed to bar clinical data from China.
“I understand the consternation around Chinese clinical trial data in the sense that they’re doing to biotech what they did to semiconductors or batteries,” Auchincloss said. “I don’t really subscribe to that analogy though. I think biotech is a separate, distinct industry.”
He added, “We certainly need to be cautious about the integrity of the data coming from China, and we should certainly avail ourselves of the ability to do surprise inspections and to guarantee data quality. The FDA certainly has the remit to do that.”
On the other hand, he believes the U.S. should impose restrictions on the ability of Chinese companies to independently commercialize drugs in the U.S. These ideas are not included in the clinical trials modernization legislation.
“We should not allow China to [undertake] commercialization ventures in the United States unless they are joint ventures with American ownership,” Auchincloss told BioCentury.
Allowing Chinese companies unfettered access to the U.S. market is a “level of control over those fourth and fifth levels of the value chain, commercialization and manufacturing, that to me are not acceptable. I think strict rules around what joint ventures have to look like are totally appropriate.”
He added that the concern is specific to China and he isn’t calling for similar restrictions to be imposed on other countries.
By: Steve Usdin
Source: BioCentury