Curr Probl Cardiol. 2019 May;44(5):148-172. doi: 10.1016/j.cpcardiol.2018.11.002. Epub 2018 Nov 9.
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.
临床试验结果为评估新药和医疗产品的安全性和疗效提供了关键的证据基础。疗效和安全性可能因内在/外在因素而在人群亚组中有所不同，包括性别、年龄、种族、民族、生活方式和遗传背景。少数族裔在心血管和其他临床试验中的代表性仍然不足。尽管人们已经认识到试验中存在多样性障碍，但可持续的解决方案却难以实现。我们研究了影响少数族裔患者参与试验意愿的障碍，并根据文献综述和评估，以及包括少数族裔患者、转诊医生、为少数族裔服务的医生的调查人员和试验协调员在内的主要利益相关者的意见，制定了潜在的解决方案，并在各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与利益相关者产生共鸣的解决方案中确定了关键主题，并创建了一个沟通信息图，以支持克服关键参与者障碍的多方利益相关者方法。
