COVID - 19大流行凸显了美国医疗保健系统长期存在的巨大不平等. As one critical step to combating this injustice, 组织必须努力争取临床试验的公平代表权.
For the first time in US history, 临床试验协调员必须遵守法定要求,增加试验患者小组的多样性. Signed by President Biden in December 2022, the Consolidated Appropriations Act, 2023年(公法117-328)要求临床试验的多样化行动计划, 提供一个长期需要的框架,以产生具有代表性的临床试验参与.
该法律指导各组织增加临床试验的可及性和多样性. To drive better representation in clinical trials, 了解代表性不足的人群与美国临床试验历史之间的关系是很重要的, 随着目前在临床试验注册过程中存在的障碍. From there, 组织可以制定可持续的战略,以确保他们的临床试验真正代表他们所bet8娱乐的人群.
Establishing Trust and Overcoming the Past
临床试验为从慢性疾病到其他疾病寻求专业医疗bet8娱乐的患者提供了新的医疗方法和创新护理, like diabetes, to the most rare and complex cancers. 后期临床试验更有可能取得成功,有些甚至被认为是肿瘤学等专业领域的标准治疗方法. As such, 在临床试验过程中提供获取途径并建立信任对于确保所有患者获得最佳结果至关重要.
部分原因是由于临床研究和整个医学界的痛苦历史, as well as structural economic, geographic, and communication-based barriers, people of color are underrepresented in clinical trials, a significant contributing factor to racial healthcare inequity. 随着供应商和研究机构寻求发展他们的多样性, equity, and inclusion (DEI) efforts, 一个关键因素将是建立强有力的机制和包容性进程,以确保医学研究能够代表它们所bet8娱乐的人群.
Importance of Designing Representative Trials
组织需要了解临床试验小组的选择过程及其对准确和公平的代表性构成的结构性障碍(见图1)。. First, a potential trial candidate must be in a region offering the appropriate trial; most clinical trial recruitment and study visits take place at academic institutions that may be difficult to access for many underserved communities due to transportation barriers. Additionally, 患者必须有经济能力参加试验, including the ability to pay for any travel, take time off work, etc.
克服这些最初障碍的患者也必须意识到他们有资格参加特定的试验. 虽然积极主动和精通医学的患者可能能够识别潜在的临床试验,并代表他们自己倡导参与其中, 大多数患者不熟悉这个过程的复杂性,因此依靠他们的护理团队来提出这个话题.
但克服地理和经济障碍只是冰山一角. 沟通方面的挑战和根深蒂固的不信任进一步阻碍了入学率.
- 语言障碍往往使临床试验的好处难以传达给非英语人群.
- People of color may view clinical trials through a lens of fear, mistrust, 以及对他们的怀疑,因为他们过去被医疗界以医学研究和科学实验的名义虐待和剥削.
- 国家学术医学院的教员和领导缺乏多样性, with little improvement observed over the past several decades.个人更有可能相信来自他们认同的人的医疗建议. As such, 代表性不足阻碍了信任的医患关系的能力, in turn, a patient’s willingness to participate in a clinical trial.
在临床试验中充分代表代表性不足的人群对于为个体参与者提供尖端医疗至关重要, 同样重要的是,要确保未来的患者接受量身定制的治疗, high-quality medical care. 有无数的研究例子表明,其结果在临床上显着且有益,但参与者小组不足以代表更广泛的人群, leading to potentially discriminatory care protocols. 必须开展具有代表性的试验,以确保护理标准的公平性,并为代表性不足的人群提供与其同龄人相同的改善的临床结果.
Awareness of healthcare inequity across America is growing, 使临床试验过程更具包容性是医疗保健组织可以采取的切实步骤,以重新设计一个对所有人都公平的系统.
Read the Full ArticleEdited by: Emily Johnson
Designed by: Mary Anne Akhouzine
Published May 18, 2023
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