Increasing Minority Enrollment Onto Clinical Trials: Practical Strategies and Challenges Emerge From the NRG Oncology Accrual Workshop

Increasing Minority Enrollment Onto Clinical Trials: Practical Strategies and Challenges Emerge From the NRG Oncology Accrual Workshop
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DOI:
10.1200/jop.2015.005934
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发表时间:
2015-11-01
影响因子:
--
通讯作者:
McCaskill-Stevens, Worta
McCaskill-Stevens, Worta
中科院分区:
医学3区
文献类型:
--
作者:
Brooks, Sandra E.;Muller, Carolyn Y.;McCaskill-Stevens, Worta

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在美国国家癌症研究所(National Cancer institute)资助的临床试验中,种族和民族多样性历来难以实现,尽管多达80%的临床试验在达到总体招募目标方面存在困难。为了解决这些问题,NRG肿瘤学最近召开了一次题为“临床试验登记:挑战和机遇”的综合研讨会。研讨会的讨论嘉宾包括NRG的三个传统小组的代表(即妇科肿瘤小组,国家外科辅助乳房和肠项目,以及放射治疗肿瘤小组),一个以少数族裔为基础的社区临床肿瘤项目,一个大型综合医疗保健系统,国家癌症研究所的领导,以及一个大型患者倡导小组。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、研究人员和研究人员的培训、具体的临床试验招募策略(基于系统和社区)以及年轻研究人员的发展和指导。提出了许多新的、更具体的策略,包括使用多样化的癌症护理环境,直接与消费者沟通,以及对集中信息技术的需求,如使用软件将试验与特殊人群相匹配。结论是,新的、创新的试验设计和有限资金的现实需要采用有效和高效的招聘策略、专门培训和利益相关者的参与。美国临床研究项目如果要保持其在癌症治疗创新和提供方面的世界领先地位,就必须产生并接受新的想法,并试点测试新的招聘策略。
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.