To evaluate differences in metrics of quality and site performance in academic and community sites participating in a multicenter study.
In the Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy study, the participation of 76 academic-based and 42 community-based US centers provided an opportunity to evaluate various metrics of quality and site performance.
A secondary data analysis of the Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy study was performed. There were 3070 treatment-naive, hepatitis C virus genotype 1 infected patients were included. We retrospectively evaluated rates of screen failure, completion, and discontinuation of treatment and follow-up, treatment adherence, and virologic response by site type.
Of the patients screened, 63% and 37% were in academic and community centers, respectively. Screen failure rates were similar (30% to 32%). End-of-treatment response, relapse, and sustained virologic response (SVR) rates in academic and community centers did not differ. SVR was achieved in 40% of patients at academic sites and 39% at community sites. Adherence to ≥80% of peginterferon-α and ribavirin dosing for ≥80% assigned duration was also similar (46% in academic and 47% in community centers). In both academic and community centers, 54% of patients completed treatment; there were similar discontinuation rates for treatment failure and adverse events.
There were no significant differences in adherence, adverse events, rates of discontinuation, on-treatment virologic response, and SVR when comparing academic and community sites. The performance of academic-based and experienced community-based sites in clinical trials is largely similar for the treatment of chronic hepatitis C.
*Oregon Health and Science University, Portland, OR
†John Hopkins University School of Medicine, Baltimore, MD
‡Merck Research Laboratories, Kenilworth, NJ
§Gilead Sciences Inc., Foster City, CA
∥Division of Gastroenterology and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
Supported by Schering-Plough Corporation, now Merck & Co. Inc., Whitehouse Station, NJ.
S.N. and L.D.P. are former employees of Merck Research Laboratories. S.N. is a former employee of Schering-Plough Corporation and has received consultant fees from Schering-Plough Corporation. Currently, she is employed by Bristol-Myers Squibb and owns stock in Merck & Co., Schering-Plough Corporation, Bristol-Myers Squibb, and Johnson and Johnson. J.L. is an employee and stock holder in Merck & Co. M.S.S. reports receiving institutional grant funding from Merck, consulting fees from Vertex, Abbott Laboratories, Bristol-Myers Squibb, Boehringer Ingelheim Pharmaceuticals, Gilead, Janssen, Merck, Novartis, and Roche/Genentech. L.D.P. is a stock holder and former employee of Merck Research Laboratories. J.G.M. has received grant support and consulting fees from Merck. A.J.M. reports having received institutional grant funding from Achillion, Bristol-Myers Squibb, Gilead, Abbott Laboratories, Pfizer, Medtronic, Merck and Co., Scynexis and Vertex, and consulting fees from Achillion, Bristol-Myers Squibb, Merck, and Vertex. J.H.J. was funded by NIDDK T32 Training Grant #3020023 and the American Association for the Study of Liver Diseases Advanced/Transplant Hepatology Fellowship Award.
Dr Jou was funded by NIDDK T32 Training Grant #3020023 and the American Association for the Study of Liver Diseases Advanced/Transplant Hepatology Fellowship Award.
Reprints: Janice H. Jou, MD, MHS, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, L-461, Portland, OR 97239 (e-mail: email@example.com).
Received October 11, 2012
Accepted March 25, 2013