HHS has directed six of its agencies to reduce regulatory barriers associated with clinical trial research to accelerate pharmaceutical development in the U.S.
The move — detailed in a road map called Operation TrailBlazer — comes as “a growing share of early stage clinical research has moved overseas,” according to a June 22 agency news release.
“HHS is taking decisive action to reverse that trend and make the United States the preferred destination for clinical research and medical discovery,” the agency said in the release.
Here are five things to know about Operation TrailBlazer:
- The issue driving the initiative, according to HHS, is how federal clinical research regulations often take years to navigate in the U.S., compared to months in other countries.
“While sponsors in the U.S. work through these requirements and wait for FDA feedback, sponsors abroad may already be generating human data that can attract investment,” the agency said in the release. - The FDA is targeting a six- to 12-month reduction in early clinical trial timelines. The agency is soliciting public comment on a pilot program that would shorten the time from drug identification to first-in-human phase 1 trials. The agency also issued draft guidance stating that one high-quality late-stage clinical trial with confirmatory evidence could be sufficient to support a drug approval in some cases.
The agency recently announced it was piloting a clinical trial model that would enable review of safety signals while a trial is being conducted. Sixteen leaders in oncology shared their reactions to the new trial model with Becker’s, including the challenges that may lie ahead. - The NIH will support the use of AI, human cell-based models and real-world data in clinical trials to move therapies to patients more efficiently.
- The Office of the National Coordinator for Health Information Technology will explore how to flag clinical trial opportunities for eligible patients through the EHR as part of routine care, while the National Cancer Institute will work to streamline and improve clinical trial activation and enrollment.
- HHS’ Office of Inspector General published a Request for Information seeking public input on whether anti-kickback safe harbors should be updated to cover clinical trial participant compensation.
Read the full Operation TrailBlazer report here.
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