Analysis of site performance in academic-based and community-based centers in the IDEAL Study.

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

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

Published Date

  • 2013

Published In

Volume / Issue

  • 47 / 10

Start / End Page

  • e91 - e95

PubMed ID

  • 23787248

Pubmed Central ID

  • PMC5144160

Electronic International Standard Serial Number (EISSN)

  • 1539-2031

Digital Object Identifier (DOI)

  • 10.1097/MCG.0b013e318294baa4


  • eng

Conference Location

  • United States