November 18, 2013

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

J Clin Gastroenterol. 2013 Nov-Dec;47(10):e91-5. doi: 10.1097/MCG.0b013e318294baa4.

Jou JH, Sulkowski MS, Noviello S, Long J, Pedicone LD, McHutchison JG, Muir AJ.

*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.


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.

PMID: 23787248 PubMed - in process]


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