Research consortium, FDA establish HCV collaboration

The Hepatitis C Therapeutic Registry and Research Network has announced a collaboration with the FDA for sharing data on the use and management of new HCV therapies, according to a press release.

The research consortium, known as HCV-TARGET, incorporates 103 locations in 31 states, as well as in Puerto Rico, Canada and Europe. Investigators from the University of Florida and the University of North Carolina at Chapel Hill lead the project, which receives sponsorship from various pharmaceutical companies. HCV-TARGET includes data from approximately 2,500 patients throughout North America, including those from populations often underrepresented in clinical trials, such as African-Americans and the elderly.

Initially, the focus of observational studies conducted by the consortium was therapy with telaprevir and boceprevir. Later this year, HCV-TARGET will expand to evaluate all antiviral HCV treatments. The collaboration was designed to utilize the HCV-TARGET database to provide clinicians and patients with information regarding available treatments for HCV, and to allow for comparisons between clinical trial data collected by the FDA and observational data collected by the consortium. A representative from the FDA also will join the HCV-TARGET advisory council.

Janet Woodcock, MD 

Janet Woodcock

“This collaboration will not only strengthen our ongoing efforts to monitor the safety and effectiveness of existing hepatitis C treatment regimens, it will also provide opportunities for FDA scientists to apply their research expertise in studying existing data held by HCV-TARGET to identify areas for improvement in clinical trial design that may help improve the future of HCV drug development programs,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release.

The Hepatitis C Therapeutic Registry and Research Network has announced a collaboration with the FDA for sharing data on the use and management of new HCV therapies, according to a press release.

The research consortium, known as HCV-TARGET, incorporates 103 locations in 31 states, as well as in Puerto Rico, Canada and Europe. Investigators from the University of Florida and the University of North Carolina at Chapel Hill lead the project, which receives sponsorship from various pharmaceutical companies. HCV-TARGET includes data from approximately 2,500 patients throughout North America, including those from populations often underrepresented in clinical trials, such as African-Americans and the elderly.

Initially, the focus of observational studies conducted by the consortium was therapy with telaprevir and boceprevir. Later this year, HCV-TARGET will expand to evaluate all antiviral HCV treatments. The collaboration was designed to utilize the HCV-TARGET database to provide clinicians and patients with information regarding available treatments for HCV, and to allow for comparisons between clinical trial data collected by the FDA and observational data collected by the consortium. A representative from the FDA also will join the HCV-TARGET advisory council.

Janet Woodcock, MD 

Janet Woodcock

“This collaboration will not only strengthen our ongoing efforts to monitor the safety and effectiveness of existing hepatitis C treatment regimens, it will also provide opportunities for FDA scientists to apply their research expertise in studying existing data held by HCV-TARGET to identify areas for improvement in clinical trial design that may help improve the future of HCV drug development programs,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release.

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