Led jointly by Dr. David Nelson at the University of Florida and Dr. Michael Fried at the University of North Carolina at Chapel Hill, the Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET) is an international research consortium created to inform the ongoing transformation of hepatitis C treatment and research. HCV-TARGET includes 103 academic and community sites in 31 states, Puerto Rico, Canada and Europe as well as partnerships with multiple industry sponsors, regulatory agencies and the patient advocacy community.
In 2011, HCV-TARGET established a national registry to observe patients undergoing hepatitis C treatment and coordinate real-world monitoring on a national scale for new therapies as they enter the market. As of April 2013, HCV-TARGET sites have enrolled approximately 1,900 patients. HCV-TARGET will release interim analyses each spring and fall to provide timely data that can inform clinical practice by improving information on populations represented and underrepresented in phase III clinical trials and identifying and remediating educational gaps and adverse event management. Over time, HCV-TARGET will study long-term morbidity, mortality and comorbidities associated with treating hepatitis C and will develop new translational studies and collaborations.
A Collaborative Model for Clinical Trials
HCV-TARGET offers a disease-agnostic model for aligning academic, government and industry resources to achieve greater cost efficiency and higher-quality, more rapid collection of real-world data for clinical trials. The HCV-TARGET model is rooted in the infrastructure and collaborative network developed through the National Institutes of Health’s Clinical and Translational Science Award (CTSA) program, which is led by the National Center for Advancing Translational Sciences. While neither CTSA nor NIH grant dollars directly fund HCV-TARGET, the network leverages CTSA-supported infrastructure including the REDCap data management platform and the UF CTSI Biorepository. With sites at 25 CTSA-supported institutions, it is one of the country’s largest CTSA-based research networks.
Utilization of CTSA infrastructure and the team’s novel and unique approach allowed HCV-TARGET to develop practical solutions for challenges such as data abstraction and monitoring in community settings and creation of an FDA-certifiable database. As a result, HCV-TARGET was able to attract approximately $12 million of support for its initial study from four pharmaceutical companies: Genentech, Kadmon, Merck and Vertex.
Joy A. Peter, RN, BSN
Associate Director, Hepatology Research, University of Florida
352-273-9513 • Joy.Peter@medicine.ufl.edu
- HCV-TARGET News
- MedPage Today, April 26, 2013: Anemia top side effect of HCV antivirals
- UF news release, April 26, 2013: International consortium exploring long-term outcomes of treating hepatitis C releases first data