Janice H Jou1, Mark S Sulkowski, Stephanie Noviello, Jianmin Long, Lisa D Pedicone, John G McHutchison, Andrew J Muir. 1. *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.
Abstract
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.
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 infectedpatients 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.
Authors: John G McHutchison; Eric J Lawitz; Mitchell L Shiffman; Andrew J Muir; Greg W Galler; Jonathan McCone; Lisa M Nyberg; William M Lee; Reem H Ghalib; Eugene R Schiff; Joseph S Galati; Bruce R Bacon; Mitchell N Davis; Pabak Mukhopadhyay; Kenneth Koury; Stephanie Noviello; Lisa D Pedicone; Clifford A Brass; Janice K Albrecht; Mark S Sulkowski Journal: N Engl J Med Date: 2009-07-22 Impact factor: 91.245
Authors: Robert P Myers; Curtis Cooper; Morris Sherman; Richard Lalonde; Helga Witt-Sullivan; Magdy Elkashab; Paul Harris; Robert Balshaw; Chistopher Usaty; Paul J Marrotta Journal: Can J Gastroenterol Date: 2011-09 Impact factor: 3.522
Authors: M P Manns; J G McHutchison; S C Gordon; V K Rustgi; M Shiffman; R Reindollar; Z D Goodman; K Koury; M Ling; J K Albrecht Journal: Lancet Date: 2001-09-22 Impact factor: 79.321
Authors: Paul Marotta; Dietrich Hueppe; Elmar Zehnter; Paul Kwo; Ira Jacobson Journal: Clin Gastroenterol Hepatol Date: 2009-05-15 Impact factor: 11.382
Authors: Elizabeth B Lamont; Mary Beth Landrum; Nancy L Keating; Laura Archer; Lan Lan; Gary M Strauss; Rogerio Lilenbaum; Harvey B Niell; L Herbert Maurer; Michael P Kosty; Antonius A Miller; Gerald H Clamon; Anthony D Elias; Edward F McClay; Everett E Vokes; Barbara J McNeil Journal: J Clin Oncol Date: 2009-11-23 Impact factor: 44.544
Authors: Ira M Jacobson; Robert S Brown; Bradley Freilich; Nezam Afdhal; Paul Y Kwo; John Santoro; Scott Becker; Adil E Wakil; David Pound; Eliot Godofsky; Robert Strauss; David Bernstein; Steven Flamm; Mary Pat Pauly; Pabak Mukhopadhyay; Louis H Griffel; Clifford A Brass Journal: Hepatology Date: 2007-10 Impact factor: 17.425
Authors: Robert P Myers; Curtis Cooper; Morris Sherman; Richard Lalonde; Helga Witt-Sullivan; Magdy Elkashab; Paul Harris; Robert Balshaw; Chistopher Usaty; Paul J Marrotta Journal: Can J Gastroenterol Date: 2011-09 Impact factor: 3.522