RESEARCH TRIANGLE PARK, N.C., July 16, 2026--(BUSINESS WIRE)--IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, shared recommendations for strengthening the United States as a leading destination for early clinical development during the U.S. House Committee on Energy and Commerce Subcommittee on Health hearing, "Maintaining America's Leadership in Biomedical Innovation: FDA's Role in Advancing U.S. Drug Development."
Recommendations were presented by Dr. Cynthia Verst, president, Design and Delivery Innovation, Research and Development Solutions at IQVIA, who highlighted the importance of making the path from scientific discovery to first-in-human studies more defined and efficient while maintaining the U.S. Food and Drug Administration's high standards for patient safety and data integrity. Her testimony focused on opportunities to modernize early clinical development, support more collaborative regulatory engagement and strengthen the broader infrastructure needed to translate scientific discoveries into potential treatments.
"The United States has an opportunity to strengthen its position as a leading destination for clinical research by creating a clearer and more efficient path from discovery to early clinical development," said Dr. Verst. "A more risk-proportionate approach to first-in-human studies, combined with timely scientific advice and stronger connections across the research ecosystem, can help promising treatments enter clinical trials sooner while preserving the patient protections that make the FDA the global gold standard."
The time and resources required to prepare an investigational new drug application is a significant barrier for sponsors seeking to initiate first-in-human studies in the United States. This is particularly important for emerging biopharmaceutical companies, which drive more than 75% of new Phase I trial starts and often depend on timely regulatory advice to guide development decisions and secure staged investment.
Dr. Verst outlined several opportunities to improve the U.S. early clinical development environment:
Establish fit-for-first-in-human minimum datasets that support safe-to-proceed decisions without compromising patient safety.
Enable more flexible, iterative interactions with FDA reviewers as scientific and regulatory questions become relevant throughout development.
Expand access to timely scientific advice, particularly for emerging biopharmaceutical companies.
Strengthen the country's bench-to-clinic infrastructure by connecting government agencies, research institutions, community practices and private-sector clinical development capabilities.
Improve patient finding and trial matching while maintaining appropriate privacy protections and making participation in clinical research more operationally viable for community practices.