The U.S. Department of Health and Human Services has announced a new initiative to accelerate the development of new treatments and encourage more medical studies to take place in the United States. The effort brings together multiple HHS agencies in a coordinated strategy to reduce barriers to clinical trials and expand access to innovative therapies.

FDA’s Role

The Food and Drug Administration is seeking public input on a pilot program aimed at shortening the timeline between drug discovery and first-in-human Phase 1 clinical trials. The agency is also clarifying regulatory expectations that could reduce early trial timelines by six to 12 months.

In addition, the FDA has issued draft guidance stating that, in many cases, a single high-quality late-stage clinical trial supported by confirmatory evidence may be sufficient to demonstrate a drug’s effectiveness for approval.

Other HHS Agencies’ Involvement

The National Institutes of Health said it will continue supporting large, well-designed clinical trials while expanding the use of emerging technologies and research methods. The agency plans to advance the responsible use of artificial intelligence, human cell-based models, real-world data, and practical clinical trial tools intended to help move promising therapies to patients more efficiently.

The HHS Office of Inspector General is seeking public feedback on whether changes are needed to certain federal regulations related to clinical trial participation. The review will examine possible updates to safe harbor regulations under the federal anti-kickback statute and rules governing incentives provided to clinical trial participants.

Original reporting: The Dallas Express — read the source article.