Fried Receives FDA Award for Regulatory Science Excellence

Unique research network is recognized for providing a robust platform that curates real-world data for FDA scientists, helping them communicate the safety and effectiveness of direct-acting antiviral agents in the post-marketing period.

Michael W. Fried, MD, professor of medicine in the department of medicine’s division of gastroenterology and hepatology, has received the Food and Drug Administration’s Award for Regulatory Science Excellence for the Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET) he co-founded in 2011. The award also recognizes HCV-TARGET as an outstanding public-private partnership that leverages real-world evidence to enhance the safety and effectiveness of direct-acting antivirals approved for chronic hepatitis C treatment.

HCV-TARGET is a consortium of 60 sites around the US and Europe, using innovative approaches related to bioinformatics, epidemiology, biostatistics, and health care data systems integration. Patients at participating sites are consented prospectively for participation. HCV-TARGET uses a centralized data abstraction process that minimizes burden on research sites and reduces data variability owing to difference in interpretation of medical records.

Prior to 2011, treatments required weekly injections with many side effects, and there was a 50% cure rate. Since then, oral treatment options have rapidly evolved and dramatically improved cure rates.

“In the beginning, we wanted to know how these oral drugs would perform in diverse groups of patients, such as those at the extremes of disease severity and in those underrepresented in phase 3 clinical trials,” said Fried, director of the UNC Liver Center.

Over 14,000 patients around the world are enrolled in the ongoing HCV-TARGET study that has generated multiple separate findings. Study data has been published in numerous publications and cited in guidelines of the American Association for the Study of Liver Diseases, the World Health Organization, and the European Association for Study of Liver Disease. Data has also been used for drug label expansion and safety surveillance.

Learn more about Michael W. Fried and the FDA award at the UNC Healthcare Newsroom.