Dilts David M, Sandler Alan B
Center for Management Research in Healthcare, Vanderbilt University, Nashville, TN, USA.
J Clin Oncol. 2006 Oct 1;24(28):4545-52. doi: 10.1200/JCO.2005.05.0104.
To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites.
VICC, a National Cancer Institute-designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data.
At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps.
There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.
调查影响范德比尔特 - 英格拉姆癌症中心（VICC）及VICC附属网络（VICCAN）各站点开展临床试验的管理障碍。
对作为美国国立癌症研究所指定的综合癌症中心的VICC以及三个VICCAN社区实践站点进行了研究。所采用的方法是识别并梳理现有流程以及分析历史时间数据。
在流程粒度方面，VICC以及VICCAN总部加当地站点所需的流程步骤分别为20步对17至30步；粒度越细，差距越大，分别超过110步对少于60步。约50%的步骤不增值。例如，在机构审查委员会（IRB）流程中，不到三分之一的步骤对最终方案有增值作用。参与审批流程的团体数量在VICC为27个，在VICCAN总部及当地站点为6至14个。VICC开展一项试验的中位时间为171天（95%CI，158至182天），VICCAN各站点为191天（95%CI，119至269天）。与预期相反，IRB审查与批准的时间（中位时间47天）相比科学审查委员会审查与批准（中位时间70天）以及合同与资助审查（中位时间78.5天）是最快的流程。开展合作组临床试验明显更快（P = .05），因为其所需的审查步骤更少。
在开展临床试验方面，存在诸多消除非增值步骤并节省时间的机会。随着新药物数量的增加、国内主要研究者数量的减少以及更多公司将临床试验外包，克服此类障碍对于维持美国核心肿瘤学研究能力至关重要。
