Beaumont Cancer Institute, William Beaumont Hospital, Royal Oak, Michigan, USA.
Cancer. 2011 Oct 15;117(20):4764-71. doi: 10.1002/cncr.26094. Epub 2011 Mar 31.
The authors reviewed changes in accrual to cancer clinical trials over the last 2 decades at their institution with a focus on minority participation after the implementation of a community clinical oncology program (CCOP) and an aggressive, education-orientated minority outreach program (MOP).
Data on patient enrollment in clinical trials for the years 1988 to 2010 was obtained from the William Beaumont Hospital (WBH) Cancer Clinical Trials Office. The type and number of cancers diagnosed and treated during the same period were obtained from the WBH tumor registry data. The MOP was initiated in the fall of 2003 with a focus on culture-specific cancer education.
With the development of the CCOP, clinical trials accrual increased significantly by 10-fold (P = .001). The primary service area for the CCOP consistently averaged an 85% to 90% Caucasian population. During the same period, the minority population for the service area remained stable between 8.8% and 10% and did not change significantly. From 1999 to 2004, the WBH tumor registry data demonstrated that minorities represented 8.6% of cancers registered, whereas the average yearly minority enrollment from 2002 to 2004 was 5.4%. After initiation of the MOP, minority accrual doubled to 11% by 2010 with stable minority demographics.
The current findings support the importance of a CCOP in supporting the accrual of patients to national clinical trials and increasing access to state-of-the art research. These data also strongly support focusing additional energy and educational efforts on targeting minority representation in clinical trials.
作者回顾了在他们的机构中过去 20 年来癌症临床试验入组的变化,重点关注社区临床肿瘤学计划(CCOP)和积极的、以教育为导向的少数民族外展计划(MOP)实施后少数民族的参与情况。
从威廉博蒙特医院(WBH)癌症临床试验办公室获得了 1988 年至 2010 年期间患者入组临床试验的数据。同时,从 WBH 肿瘤登记数据中获得了同期诊断和治疗的癌症类型和数量。MOP 于 2003 年秋季启动,重点是具有文化特异性的癌症教育。
随着 CCOP 的发展,临床试验的入组率显著增加了 10 倍(P =.001)。CCOP 的主要服务区域平均有 85%至 90%的白种人人口。在此期间,服务区域的少数民族人口保持在 8.8%至 10%之间,没有明显变化。从 1999 年到 2004 年,WBH 肿瘤登记数据表明,少数民族占登记癌症的 8.6%,而 2002 年至 2004 年的少数民族年平均入组率为 5.4%。MOP 启动后,少数民族入组率在 2010 年翻了一番,达到 11%,少数民族人口统计数据保持稳定。
目前的研究结果支持 CCOP 在支持患者参加国家临床试验和增加获得最新研究的机会方面的重要性。这些数据还强烈支持将更多的精力和教育努力集中在临床试验中少数民族代表的目标上。