IQVIA executive testifies before Congress on early clinical trials

An IQVIA (NYSE: IQV) executive testified before a U.S. House subcommittee, offering recommendations to streamline early-stage clinical drug development in the United States while maintaining existing patient safety standards.

Dr. Cynthia Verst, president of Design and Delivery Innovation, Research and Development Solutions at IQVIA, appeared before the House Committee on Energy and Commerce Subcommittee on Health during a hearing titled "Maintaining America's Leadership in Biomedical Innovation: FDA's Role in Advancing U.S. Drug Development."

Her testimony focused on reducing barriers associated with preparing investigational new drug applications, which she described as a significant obstacle for sponsors seeking to initiate first-in-human studies in the U.S. According to the press release, emerging biopharmaceutical companies account for more than 75% of new Phase I trial starts and frequently rely on timely regulatory guidance to inform development decisions and attract staged investment.

"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," Dr. Verst said.

Dr. Verst outlined several specific recommendations, including establishing minimum datasets to support safe-to-proceed decisions for first-in-human studies, enabling more flexible interactions with FDA reviewers, expanding access to scientific advice for emerging companies, strengthening connections between government agencies and research institutions, and improving patient recruitment while maintaining privacy protections.

The subcommittee hearing also examined opportunities to modernize regulatory requirements through innovative trial designs, digital health technologies and greater coordination across clinical protocols.

You May Also Be Interested In

• FDA Committee Recommends To Widen Access To Bpc-157 Peptide
• Oracle wins $6.99B DoW software contract under ESI program
• Mapfre to acquire Safety Insurance Group in $1.54B all-cash deal