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提高淋巴瘤临床试验中代表性不足的少数群体入组率的新策略。

New strategies for enhancing enrollment of underrepresented minorities in lymphoma clinical trials.

作者信息

Nze Chijioke, Herrera Alex F

机构信息

Department of Lymphoma & Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.

Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.

出版信息

Blood Adv. 2025 Feb 25;9(4):774-782. doi: 10.1182/bloodadvances.2024012981.

Abstract

New lymphoma treatments, including chimeric antigen receptor T cells, bispecific antibodies, and immune checkpoint inhibitors, have significantly improved patient outcomes. Despite these therapeutic advances, only 2% to 3% of adult patients with cancer participate in clinical trials. This participation is even lower among certain groups, including ethnic and racial minorities, individuals with low socioeconomic status, rural residents, older adults, and young adults. Underrepresentation of these groups in clinical trials limits the generalizability of trial results and is detrimental to those populations that do not receive equal access to novel therapies. Although racial and ethnic minorities constitute >40% of the US population, they make up only ∼15% of clinical trial participants. The US Food and Drug Administration now requires sponsors seeking regulatory approval for therapies via registrational clinical trials to submit a plan to ensure diversity among trial participants. This article addresses strategies for enhancing enrollment of underrepresented minorities in lymphoma clinical trials.

摘要

包括嵌合抗原受体T细胞、双特异性抗体和免疫检查点抑制剂在内的新型淋巴瘤治疗方法显著改善了患者的治疗效果。尽管有这些治疗进展,但只有2%至3%的成年癌症患者参与临床试验。在某些群体中,包括少数族裔、社会经济地位较低的个体、农村居民、老年人和年轻人,这种参与率甚至更低。这些群体在临床试验中的代表性不足限制了试验结果的普遍性,并且对那些无法平等获得新疗法的人群不利。尽管少数族裔占美国人口的40%以上,但他们仅占临床试验参与者的约15%。美国食品药品监督管理局现在要求通过注册临床试验寻求疗法监管批准的申办者提交一份计划,以确保试验参与者的多样性。本文探讨了提高淋巴瘤临床试验中代表性不足的少数族裔参与率的策略。

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