增加临床试验患者多样性的可行策略

Justin Brathwaite, Marley Wolgast, Sara E. Bickhart
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引用次数: 0

摘要

在美国,制药行业正在积极制定战略,以提高临床试验参与者的多样性。这些努力源于大量证据表明,不同种族群体对特定治疗的反应不同。因此,增加试验参与者的多样性不仅可以提供更有力和更具代表性的试验数据,还可以带来更安全、更有效的治疗方法。进一步使试验参与者多样化似乎很简单,但这是一个复杂的过程,需要来自多个利益相关者的反馈,如制药赞助商、监管机构、社区领袖和研究机构。因此,本文的目的是描述三种可能增加临床试验参与者多样性的可行策略:(1)临床研究队伍的多样化。(2) 采用现场评估工具的多样性,以及(3)将分散的临床试验技术纳入临床试验设计。
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Viable Strategies to Increase Clinical Trial Patient Diversity
In the United States, the pharmaceutical industry is actively devising strategies to improve the diversity of clinical trial participants. These efforts stem from a plethora of evidence indicating that various ethnic groups respond differently to a given treatment. Thus, increasing the diversity of trial participants would not only provide more robust and representative trial data but also lead to safer and more effective therapies. Further diversifying trial participants appear straightforward, but it is a complex process requiring feedback from multiple stakeholders such as pharmaceutical sponsors, regulators, community leaders, and research sites. Therefore, the objective of this paper is to describe three viable strategies that can possibly increase the diversity of clinical trial participants: (1) Diversification of the clinical research workforce. (2) Adoption of the diversity in site assessment tool, and (3) incorporation of decentralized clinical trial technologies into clinical trial designs.
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CiteScore
0.10
自引率
0.00%
发文量
34
审稿时长
12 weeks
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