Brooks Sandra E, Muller Carolyn Y, Robinson William, Walker Eleanor M, Yeager Kate, Cook Elise D, Friedman Sue, Somkin Carol P, Brown Carol Leslie, McCaskill-Stevens Worta
CompleteCare Health Network, Bridgeton, NJ; University of New Mexico, Albuquerque, NM; Tulane University, New Orleans, LA; Henry Ford Hospital, Detroit, MI; Emory University, Atlanta, GA; University of Texas MD Anderson Cancer Center, Houston, TX; Facing Our Risk of Cancer Empowered, Tampa, FL; Kaiser Permanente, Oakland, CA; Memorial Sloan Kettering Cancer Center, New York, NY; and National Cancer Institute, Bethesda, MD
CompleteCare Health Network, Bridgeton, NJ; University of New Mexico, Albuquerque, NM; Tulane University, New Orleans, LA; Henry Ford Hospital, Detroit, MI; Emory University, Atlanta, GA; University of Texas MD Anderson Cancer Center, Houston, TX; Facing Our Risk of Cancer Empowered, Tampa, FL; Kaiser Permanente, Oakland, CA; Memorial Sloan Kettering Cancer Center, New York, NY; and National Cancer Institute, Bethesda, MD.
J Oncol Pract. 2015 Nov;11(6):486-90. doi: 10.1200/JOP.2015.005934. Epub 2015 Oct 13.
Racial and ethnic diversity has historically been difficult to achieve in National Cancer Institute-sponsored clinical trials, even while as many as 80% of those trials have faced difficulty in meeting overall recruitment targets. In an attempt to address these issues, NRG Oncology recently convened a comprehensive workshop titled "Clinical Trials Enrollment: Challenges and Opportunities." Discussants at the workshop included representatives of the three legacy groups of the NRG (ie, Gynecologic Oncology Group, National Surgical Adjuvant Breast and Bowel Program, and Radiation Therapy Oncology Group), a minority-based community clinical oncology program, a large integrated health care system, the leadership of the National Cancer Institute, and a large patient advocacy group. This article summarizes the concepts discussed at the workshop, which included: needs assessments, infrastructural support, training of investigators and research staff, specific clinical trial recruitment strategies (both system and community based), and development and mentoring of young investigators. Many new, more specific tactics, including use of diverse cancer care settings, direct-to-consumer communication, and the need for centralized information technology such as the use of software to match trials to special populations, are presented. It was concluded that new, innovative trial designs and the realities of limited funding would require the adoption of effective and efficient recruiting strategies, specialized training, and stakeholder engagement. US clinical research programs must generate and embrace new ideas and pilot test novel recruitment strategies if they are to maintain their historic role as world leaders in cancer care innovation and delivery.
从历史上看,在国立癌症研究所赞助的临床试验中,种族和民族多样性一直难以实现,即便多达80%的此类试验在实现总体招募目标方面面临困难。为解决这些问题,NRG肿瘤学组织最近召开了一次全面的研讨会,题为“临床试验招募:挑战与机遇”。研讨会上的讨论者包括NRG三个传统组织(即妇科肿瘤学组、国家乳腺与肠道外科辅助治疗计划以及放射治疗肿瘤学组)的代表、一个基于少数族裔的社区临床肿瘤学项目、一个大型综合医疗保健系统、国立癌症研究所的领导层以及一个大型患者权益倡导组织。本文总结了研讨会上讨论的概念,其中包括:需求评估、基础设施支持、研究人员和研究 staff 的培训、具体的临床试验招募策略(包括基于系统和社区的策略)以及年轻研究人员的培养和指导。还介绍了许多新的、更具体的策略,包括利用多样化的癌症护理环境、直接面向消费者的沟通以及对集中式信息技术的需求,如使用软件将试验与特殊人群进行匹配。得出的结论是,新的、创新的试验设计以及资金有限的现实情况将需要采用有效且高效的招募策略、专门培训以及利益相关者的参与。如果美国临床研究项目要保持其作为癌症护理创新与提供领域世界领导者的历史角色,就必须产生并接受新想法,并对新颖的招募策略进行试点测试。