HHS Aims to Bolster Clinical Research, Drug Development

June 23, 2026

The U.S. Department of Health and Human Services this week announced a department-wide initiative to accelerate early- and late-stage drug development and expand domestic clinical research.

The initiative aims remove barriers in an effort to recapture clinical research that has moved overseas and “make the United States the preferred destination for clinical research and medical discovery.”

Here are key points to know:

• Drug development pilot:  The FDA is soliciting comments on a proposed pilot to reduce early trial timelines by six to 12 months.
• Shorter approval:  In addition, the FDA issued draft regulatory guidance clarifying that one high-quality late-stage trial with confirmatory evidence will be sufficient to support drug approval in many cases.
• Other initiatives:  As part of the broader initiative, the National Institutes of Health will lead several efforts to support clinical trials, accelerate therapies for rare diseases, and streamline cancer studies. The Office of the National Coordinator for Health Information Technology and Advanced Research Projects Agency for Health will also play roles modernizing and advancing research.
• Quotable: “HHS will continue working with industry, academic medical centers, contract research organizations, patient groups, health care providers, and other partners to identify barriers to clinical research and remove unnecessary obstacles that slow innovation,” the department said in a news release.

Information on the HHS initiative is available online.