Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Campus Box 7411, 1102A McGavran-Greenberg Hall, Chapel Hill, NC 27599, USA.
Contemp Clin Trials. 2012 Jan;33(1):46-54. doi: 10.1016/j.cct.2011.09.007. Epub 2011 Oct 2.
The National Cancer Institute's (NCI) Community Clinical Oncology Program (CCOP) contributes one third of NCI treatment trial enrollment ("accrual") and most cancer prevention and control (CP/C) trial enrollment. Prior research indicated that the local clinical environment influenced CCOP accrual performance during the 1990s. As the NCI seeks to improve the operations of the clinical trials system following critical reports by the Institute of Medicine and the NCI Operational Efficiency Working Group, the current relevance of the local environmental context on accrual performance is unknown.
This longitudinal quasi-experimental study used panel data on 45 CCOPs nationally for years 2000-2007. Multivariable models examine organizational, research network, and environmental factors associated with accrual to treatment trials, CP/C trials, and trials overall.
For total trial accrual and treatment trial accrual, the number of active CCOP physicians and the number of trials were associated with CCOP performance. Factors differ for CP/C trials. CCOPs in areas with fewer medical school-affiliated hospitals had greater treatment trial accrual.
Findings suggest a shift in the relevance of the clinical environment since the 1990s, as well as changes in CCOP structure associated with accrual performance. Rather than a limited number of physicians being responsible for the preponderance of trial accrual, there is a trend toward accrual among a larger number of physicians each accruing relatively fewer patients to trial. Understanding this dynamic in the context of CCOP efficiency may inform and strengthen CCOP organization and physician practice.
美国国家癌症研究所（NCI）的社区临床肿瘤学计划（CCOP）贡献了 NCI 治疗试验入组的三分之一（“入组”），并且是大多数癌症预防和控制（CP/C）试验入组的主要来源。先前的研究表明，当地临床环境会影响 20 世纪 90 年代 CCOP 的入组表现。由于 NCI 希望在医学研究所和 NCI 运营效率工作组的关键报告之后改进临床试验系统的运营，因此目前当地环境背景对入组表现的相关性尚不清楚。
本纵向准实验研究使用了 2000-2007 年全国 45 个 CCOP 的面板数据。多变量模型检验了与治疗试验、CP/C 试验和总体试验入组相关的组织、研究网络和环境因素。
对于总试验入组和治疗试验入组，活跃的 CCOP 医生人数和试验数量与 CCOP 的表现相关。CP/C 试验的因素有所不同。与附属医学院较少的医院的 CCOPs 治疗试验的入组率更高。
研究结果表明，自 20 世纪 90 年代以来，临床环境的相关性发生了变化，与入组表现相关的 CCOP 结构也发生了变化。入组的医生人数逐渐增加，而不是少数医生负责绝大多数的试验入组，而是越来越多的医生负责相对较少的患者入组。在 CCOP 效率的背景下了解这种动态，可能会为 CCOP 的组织和医生实践提供信息和支持。
