A draft legislation aimed at accelerating drug discovery and clinical trials has been proposed in the US.
Democratic Congressman Jake Auchincloss, the representative for Massachusetts’ 4th congressional district, has proposed a new piece of legislation, “Next Generation US Clinical Development to Accelerate Cures Proposal”, which is currently in its draft phase. Public feedback is open until 30 June.
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This legislative proposal aims to modernise the clinical development of innovative biomedical products to match the accelerating pace of discovery and preclinical development of breakthrough innovation.
It builds on work from existing authorities with targeted practical steps to facilitate lead point-of-care and clinical trial “platform” approaches to integrating clinical research into routine care.
It also pushes for a public-private and cross-agency collaboration to improve clinical research and clinical care, as well as lowering trial costs, accelerating enrolment, expanding patient access, and enabling US leadership in global clinical development reforms.
In the near term, the proposed legislation will launch regional and national pilot trial platforms, identify and implement targeted regulatory updates and leverage emerging CMS/ONC data and interoperability standards to facilitate real-world clinical research and implement key modernisations in Phase I testing to reduce costs and accelerate clinical launches.
In the medium term, the proposed legislation will scale lead platforms and extend platform capabilities to support research embedded in clinical care to a broader range of high-burden disease areas and health care organisations.
It also aims to integrate routine use of real-world data and studies into product approvals, labelling, and other relevant evidence to accelerate the impact of transformative therapies. Finally, the framework should advance the adoption of aligned reforms in other regulatory agencies, to enable a more efficient, reliable, and confident global regulation of innovative medical products.
In response, Dr Jennifer Carter, the founder and CEO of precision medicine company Medzown, said: “Clinical trials must be integrated into the standard of care as part of the care continuum. Today, clinical trials are often considered as an after-thought generally after patients have exhausted other treatments available commercially. Thus, only ~6% of patients participate in clinical trials. This leads to worse outcomes, more side effects, poor patient experience, and drives up health care costs. In fact, over 33% of health care costs are driven by patients with cancer, rare and other complex diseases. Diseases where innovative therapies have transformed care for some and are desperately needed by others.
“Efforts like Jake Auchincloss’s to transform the system, together with companies like Medzown, can better ensure patients have access to the right treatments at the right time.”
China becoming growing force
This comes as China is becoming a more dominant force in the clinical trial landscape, an area historically dominated by the US.
Research shows that in the US, the percentage of trials initiated has dropped from 49% in 2015 to 33% in 2025. Meanwhile, China has seen a significant rise, from 4% in 2015 to 30% in 2025.
This push is translating into results for China, with data showing it takes seven months on average for Phase I trials compared to 17 or more in the US. In addition, Phase I trial costs in China are 32% to 52% lower than in the US.
Speaking at Outsourcing in Clinical Trials East Coast, which took place on 12 and 13 May in New Brunswick, New Jersey, Peter Barschdorff, vice president and head of Deallus, a GlobalData company, said: “The speed is just unbelievable. Not only is China cheaper, but also faster, and can lead to the approval of the asset much earlier. Of course, there are some risks – not everything is as well-oiled a machine as US headquartered companies, but the numbers are quite complex and convincing.”
Due to this movement, Barschdorff believes that companies should aim to refine their strategies to consider China.
Despite China’s growing influence, the FDA still sets the global standard for drug approvals, though the Chinese Government has made a significant push to strengthen its life sciences contributions.
The government in China has made the regulatory environment much easier. Timelines in China are now similar to those in the US, both on the front end and the back end,” says Johnathan Kornstein, vice president of rare disease and paediatrics at Caidya.
Kornstein also believes the strong funding landscape in China is contributing to its growth.
GlobalData is the parent company of Clinical Trials Arena.
Confidence in pharma landscape growing
GlobalData’s State of the Biopharmaceutical Industry 2026 (Mid-Year Update), which surveyed 157 pharmaceutical professionals, found that 55% of respondents felt optimistic or very optimistic about industry growth over the next 12 months. This is up 46% from 2023 – a time when there were widespread concerns regarding funding and capital costs.
Current optimism within the sector comes despite a significant political overhaul in the past year, particularly in the US. President Donald Trump has threatened pharma companies with tariffs and implemented Most Favored Nation (MFN) drug pricing. This coincides with a tumultuous era at the US Food and Drug Administration (FDA), which has included former FDA commissioner Marty Makary standing down as head of the agency, with a successor not yet appointed.
