加强临床试验多样性

Robert A. Tumasian
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引用次数: 0

摘要

临床试验被认为是生物医学研究的黄金标准,是支持医疗产品和器械安全性和有效性评价的首选方法。然而,根据内在和外在因素,如年龄、性别、性别、种族、民族、生活方式和地点,在目标人群的不同亚组中,安全性和有效性可能存在很大差异。此外,一些群体继续不一致地被纳入临床试验,这是基于他们在总患病人口中的代表性,这需要认真解决。从文献综述中,本文提出了几种可能的策略来克服临床试验获取和丰富的障碍。
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Toward Enhancing Clinical Trial Diversity
Clinical trials are considered the gold standard for biomedical research, and they are the preferred method to support the safety and efficacy evaluation of medical products and devices. However, safety and effectiveness can vary substantially among different subgroups of a target population according to both intrinsic and extrinsic factors, such as age, sex, gender, race, ethnicity, lifestyle, and location. Moreover, some groups continue to be inconsistently included in clinical trials based on their representation in the total afflicted population, which demands serious resolution. From literature review, this article imparts several possible strategies to overcome obstacles in clinical trial access and enrichment.
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