Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.
Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.
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DOI：
10.1016/j.cpcardiol.2018.11.002
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发表时间：
2019-05-01
影响因子：
4.2
通讯作者：
Regnante, Jeanne M
中科院分区：
文献类型：
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作者：
Clark, Luther T;Watkins, Laurence;Regnante, Jeanne M
临床试验结果为评价新药和医疗产品的安全性和有效性提供了重要的证据基础。根据内在/外在因素，包括性别、年龄、种族、民族、生活方式和遗传背景，不同人群亚组的疗效和安全性可能不同。少数族裔在心血管和其他临床试验中的代表性仍然偏低。尽管试验中的多样性障碍是公认的，但克服这些障碍的可持续解决办法被证明是难以捉摸的。我们调查了影响少数族裔患者参与试验意愿的障碍，并基于文献回顾和评估，以及关键利益相关者的意见，包括少数族裔患者、转诊医生、为少数族裔服务的调查人员和试验协调员-制定了潜在的解决方案，并在利益相关者群体中进行了测试。我们使用行为改变的跨理论模型从解决方案中确定了与利益相关者产生共鸣的关键主题，并创建了沟通信息地图，以支持多方利益相关者克服关键参与者障碍的方法。
Clinical trial results provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. Efficacy and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including sex, age, race, ethnicity, lifestyle, and genetic background. Racial and ethnic minorities continue to be underrepresented in cardiovascular and other clinical trials. Although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proved elusive. We investigated barriers impacting minority patients' willingness to participate in trials and-based on literature review and evaluation, and input from key stakeholders, including minority patients, referring physicians, investigators who were minority-serving physicians, and trial coordinators-formulated potential solutions and tested them across stakeholder groups. We identified key themes from solutions that resonated with stakeholders using a transtheoretical model of behavior change and created a communications message map to support a multistakeholder approach for overcoming critical participant barriers.