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Analysis of Site Performance in Academic-based and Community-based Centers in the IDEAL Study

Jou, Janice H. MD, MHS*; Sulkowski, Mark S. MD; Noviello, Stephanie MD; Long, Jianmin PhD; Pedicone, Lisa D. PhD; McHutchison, John G. MD§; Muir, Andrew J. MD, MHS

doi: 10.1097/MCG.0b013e318294baa4
ONLINE ARTICLE: Original Articles
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Goals: To evaluate differences in metrics of quality and site performance in academic and community sites participating in a multicenter study.

Background: 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.

Study: 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.

Results: 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.

Conclusions: 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: jou@ohsu.edu).

Received October 11, 2012

Accepted March 25, 2013

© 2013 by Lippincott Williams & Wilkins