Analysis of site performance in academic-based and community-based centers in the ideal study

Janice H. Jou, Mark S. Sulkowski, Stephanie Noviello, Jianmin Long, Lisa D. Pedicone, John G. McHutchison, Andrew J. Muir

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)e91-e95
JournalJournal of clinical gastroenterology
Volume47
Issue number10
DOIs
StatePublished - Jan 1 2013

Keywords

  • Hepatitis C
  • Peginterferon-α
  • Ribavirin
  • Site

ASJC Scopus subject areas

  • Gastroenterology

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    Jou, J. H., Sulkowski, M. S., Noviello, S., Long, J., Pedicone, L. D., McHutchison, J. G., & Muir, A. J. (2013). Analysis of site performance in academic-based and community-based centers in the ideal study. Journal of clinical gastroenterology, 47(10), e91-e95. https://doi.org/10.1097/MCG.0b013e318294baa4