An institutional strategy to increase minority recruitment to therapeutic trials
An institutional strategy to increase minority recruitment to therapeutic trials
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DOI：
10.1007/s10552-013-0258-1
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发表时间：
2013-10-01
影响因子：
2.3
通讯作者：
Colditz, Graham A.
中科院分区：
文献类型：
--
作者：
Anwuri, Victoria V.;Hall, Lannis E.;Colditz, Graham A.
参与治疗性临床试验很少反映患者群体的种族和民族组成。为了实现国家卫生研究所规定的目标，需要制定提高参与的战略。我们提出了一个制度框架，以加强少数群体临床试验的累积。我们在四个层面上实施了结构变化，以诱导和维持临床试验的少数应计性：(1)领导支持；(2)中心范围内的政策变化；(3)基础流程控制、数据分析和报告；(4)临床随访。议定书审查和监测委员会审查研究并监测应计收益，消除癌症差异规划领导按比例应计收益的工作，通过数据跟踪、网络工具和向调查人员提供反馈来支持该系统。在2005年实施后，少数人应计治疗试验从2005年的12.0%增加到2010年的14.0%。在此期间，该机构少数族裔癌症的“滚动平均”发病率为17.5%。除了治疗性试验的累积率外，我们注意到从2005年到2010年，参加所有试验（治疗性和非治疗性）的少数民族人数显著增加（346-552，增加60%，p < 0.05），而白种人增加52%。实施一个系统来帮助研究人员规划和建立目标，同时要求将这部分内容作为年度方案审查和监测的一部分，提供了一个成功的策略，可以在其他癌症中心复制，这种方法可以扩展到其他临床和转化研究中心。
Participation in therapeutic clinical trials rarely reflects the race and ethnic composition of the patient population. To meet National Institutes of Health-mandated goals, strategies to increase participation are required. We present a framework for institutional enhancement of minority clinical trial accrual.We implemented structural changes on four levels to induce and sustain minority accrual to clinical trials: (1) leadership support; (2) center-wide policy change; (3) infrastructural process control, data analysis, and reporting; and (4) follow-up with clinical investigators. A Protocol Review and Monitoring Committee reviews studies and monitors accrual, and the Program for the Elimination Cancer Disparities leads efforts for proportional accrual, supporting the system through data tracking, Web tools, and feedback to investigators.Following implementation in 2005, minority accrual to therapeutic trials increased from 12.0 % in 2005 to 14.0 % in 2010. The "rolling average" minority cancer incidence at the institution during this timeframe was 17.5 %. In addition to therapeutic trial accrual rates, we note significant increase in the number of minorities participating in all trials (therapeutic and nontherapeutic) from 2005 to 2010 (346-552, 60 % increase, p < 0.05) compared to a 52 % increase for Caucasians.Implementing a system to aid investigators in planning and establishing targets for accrual, while requiring this component as a part of annual protocol review and monitoring of accrual, offers a successful strategy that can be replicated in other cancer centers, an approach that may extend to other clinical and translational research centers.