CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:New strategies for enhancing enrollment of underrepresented minorities in lymphoma clinical trials.
New strategies for enhancing enrollment of underrepresented minorities in lymphoma clinical trials.
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新型淋巴瘤治疗手段,包括CAR-T 细胞、双特异性抗体和免疫检查点抑制剂,已显著改善患者预后。尽管取得了这些治疗进展,但只有2%至3%的成人癌症患者参与临床试验。在某些群体中,这一参与率甚至更低,包括少数族裔和种族少数群体、社会经济地位较低者、农村居民、老年人和年轻成人。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适用性,并且对那些无法平等获得新疗法的群体有害。尽管种族和族裔少数群体占美国人口的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性临床试验寻求疗法监管批准的申办方提交一项计划,以确保试验参与者具有多样性。本文探讨了提高代表性不足的少数群体在淋巴瘤临床试验中入组率的策略。
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.
在 PubMed 查看 → 出版商原文(DOI) 全文 PDF(PMC)· 可下载 治疗专题与资料阅读指南 资料来源与翻译说明 报告译文或资料问题 →
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