*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.
J Clin Gastroenterol. 2013 Nov-Dec;47(10):e91-5. doi: 10.1097/MCG.0b013e318294baa4.
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.
评估参与多中心研究的学术和社区站点在质量和站点绩效指标方面的差异。
在个体化剂量疗效与常规剂量评估聚乙二醇干扰素治疗最佳方案的研究中，76 个学术基地和 42 个社区基地的参与为评估各种质量和站点绩效指标提供了机会。
对个体化剂量疗效与常规剂量评估聚乙二醇干扰素治疗最佳方案的研究进行了二次数据分析。共有 3070 例初治、丙型肝炎病毒基因型 1 感染患者纳入研究。我们回顾性评估了不同类型站点的筛选失败率、完成率和治疗及随访中断率、治疗依从性和病毒学应答情况。
在接受筛选的患者中，分别有 63%和 37%来自学术和社区中心。筛选失败率相似（30%至 32%）。学术和社区中心的治疗结束时应答率、复发率和持续病毒学应答率（SVR）无差异。学术中心有 40%的患者和社区中心有 39%的患者获得 SVR。对≥80%的聚乙二醇干扰素-α和利巴韦林剂量的≥80%规定时间的依从性也相似（学术中心为 46%，社区中心为 47%）。在学术和社区中心，均有 54%的患者完成治疗；因治疗失败和不良反应导致的停药率相似。
在比较学术和社区站点时，在依从性、不良事件、停药率、治疗期间病毒学应答和 SVR 方面没有显著差异。学术基地和经验丰富的社区基地在治疗慢性丙型肝炎的临床试验中的表现基本相似。
