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公平获得临床试验的机会:我们如何实现?

Equitable Access to Clinical Trials: How Do We Achieve It?

机构信息

Cancer Immunotherapy Program, Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY.

Early Phase Research, Clinical Research Center, University of Kansas Cancer Center, Fairway, KS.

出版信息

Am Soc Clin Oncol Educ Book. 2023 May;43:e389838. doi: 10.1200/EDBK_389838.

Abstract

The mismatch between the study populations participating in oncology clinical trials and the composition of the targeted cancer population requires urgent amelioration. Regulatory requirements can mandate that trial sponsors enroll diverse study populations and ensure that regulatory revue prioritizes equity and inclusivity. A variety of projects directed at increasing accrual of underserved populations to oncology clinical trials emphasize best practices: broadened eligibility requirements for trials, simplification of trial procedures, community outreach through patient navigators, decentralization of clinical trial procedures and institution of telehealth, and funding to offset costs of travel and lodging. Substantial improvement will require major changes in culture in the educational and professional practice, research, and regulatory communities and will require major increases in public, corporate, and philanthropic funding.

摘要

肿瘤学临床试验的研究人群与目标癌症人群的构成之间存在不匹配的情况,需要紧急改善。监管要求可以规定试验赞助商招募多样化的研究人群,并确保监管审查优先考虑公平性和包容性。各种旨在增加服务不足人群参与肿瘤学临床试验的项目强调了最佳实践:扩大试验的资格要求,简化试验程序,通过患者导航员进行社区外展,分散临床试验程序并实施远程医疗,以及提供资金以抵消旅行和住宿费用。要取得实质性的改善,需要在教育和专业实践、研究以及监管界进行重大的文化变革,并且需要大幅度增加公众、企业和慈善资金。

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