Cong. Auchincloss Seeks Views from Public on Clinical Trials Reform

Above image from a short explanatory video about existing trials process from the National Cancer Institute.

According to a press release from the office of  Congressman Jake Auchincloss, the United States has long led the world in biomedical discovery, translation into clinical research, and approvals of new cures and life-changing treatments. However, America’s clinical research enterprise has not kept pace and is fragmented and difficult to integrate into care sites. A discussion draft [of new legislation] aims to modernize and improve the clinical trials process for faster and more accessible clinical trials in the U.S.

For more information or to share a comment on Rep. Auchincloss' Legislative Discussion Draft of the Next-Generation U.S. Clinical Development to Accelerate Cures Proposal, please feel free to reach out to Nikita Varman, Health Policy Advisor, Congressman Auchincloss (MA-04) at nikita.varman@mail.house.gov. The deadline for feedback submission is June 30.

Please submit feedback here.

The Introduction to the draft appears below: 

This legislative proposal aims to modernize the clinical development of innovative biomedical products to match the accelerating pace of discovery and preclinical development of breakthrough innovations, through implementing clinical trial platforms to enable the shift from a separate, fragmented system into a core function of U.S. health care, and through linking more efficient clinical trial capabilities to modernized Phase 1 clinical development and opportunities to advance these reforms through global regulatory alignment.

This proposal addresses these aims through the Cures in Care Initiative (CCI) to provide a pathway to embed clinical trials into routine U.S. health care delivery and a complementary set of proposals for Modernized Preclinical and Early-Stage Clinical Development and Enhanced FDA Transparency. These reforms together can modernize the clinical development process, turning promising scientific breakthroughs into faster and broader access to cures for unmet health needs in the U.S. and worldwide.

This proposal accelerates a structural modernization of how clinical trials are conducted and how early-stage clinical development occurs. It builds on existing federal authorities and proven models to scale and emphasizes:
• Use of existing authorities with targeted practical steps to facilitate lead point-of-care and clinical trial “platform” approaches to integrating clinical research into routine care
• Public-private and cross-agency collaboration to improve clinical research and clinical care
• Pilot-based scaling with measurable outcomes in lowering trial costs, accelerating enrollment, expanding patient access, and enabling U.S. leadership in global clinicaldevelopment 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
• Implement key modernizations in Phase 1 testing to reduce costs and accelerate clinical launches
In the medium term (by 5 years), 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 organizations
• Integrate routine use real-world data and studies into product approvals, labeling, and other relevant evidence to accelerate the impact of transformative therapies
• Advance the adoption of aligned reforms in other regulatory agencies, to enable a more efficient, reliable, and confident global regulation of innovative medical products