The study: LatinX/HIspanic Attitudes and Perspectives on Investigations and Studies- of New Drugs: LAPIS-ND

研究：拉丁裔/西班牙裔对新药调查和研究的态度和观点：LAPIS-ND

• 批准号: 10639980
• 负责人: JANICE B SCHWARTZ
• 金额: $ 47.04万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10639980
• 关键词: study; LatinX; HIspanic; Attitudes; Perspectives

Participants in clinical trials should reflect the individuals who may one day receive the therapeutic agent to assure both efficacy and safety in clinical patient populations. People self-identifying as Hispanic/LatinX are a rapidly growing segment of both the total U.S. population and in proportions of patients and older adults seeking medical care. Yet, participation of older adults self-described as Hispanic/LatinX is amongst the lowest in clinical trials to evaluate new medical therapies. There is evidence that the Hispanic/LatinX population may respond differently to therapeutic agents due to both genetic factors as well as environmental influences. If Hispanic/LatinX patients are not participating in clinical trials to determine the safety and efficacy of new therapeutic agents, this presents a major gap in knowledge that is needed to use these therapeutic agents during clinical care. Our overall goal is to understand perceptions evaluations of new medical therapies, and obstacles, facilitators and priorities regarding participation in clinical trials from older adult Hispanic/LatinX patients that have been under-represented in clinical trials to date. In this proposal, we focus on Hispanic/ LatinX of Mexican origin, as this population represents the largest proportion of Hispanic/LatinoX in the U.S. Conceptually, in order to participate in medical research or clinical trials, individuals must have the capability, opportunity, and motivation to participate. To increase representation of older Hispanic/LatinX adults in clinical trials, it is key to identify motivational factors as well as barriers to participation. This information can only be obtained using qualitative study designs such as focus groups or interviews. Therefore, we propose to conduct focus groups with older adults self-identifying as Hispanic/LatinX of Mexican origin to elicit attitudes about clinical trials of new medical therapies with the emphasis on perceived barriers and facilitators to participation. Importantly, we will probe for perceptions of proposed new clinical trial designs such as use of digital interfaces, community sites, and in-home visits, We will recruit from community sites as well as clinical sites and focus groups will be conducted in community settings or by telephone in either the English or Spanish language as preferred by participants. Our work is likely to generate new information on 1) ways in which healthcare researchers or systems can address barriers to research participations of older Mexican Americans; and 2) preferred formats (e.g., verbal, written) for recruitment, sites for conduct of studies, and sources of information, types of testing that is acceptable, and 3) motivating factors for participation.

临床试验的参与者应反映有一天可能接受治疗剂的个人， 确保临床患者人群的疗效和安全性。自我认同为西班牙裔/拉丁裔的人是一个 在美国总人口以及患者和老年人中的比例都在迅速增长 寻求医疗护理。然而，自称为西班牙裔/拉丁裔的老年人的参与率是最低的 临床试验来评估新的医学疗法。有证据表明，西班牙裔/拉丁裔人口可能 由于遗传因素和环境影响，对治疗剂的反应不同。如果 西班牙裔/LatinX患者未参与确定新的安全性和有效性的临床试验 然而，在使用这些治疗剂所需的知识方面存在重大差距， 在临床护理期间。我们的总体目标是了解新的医学疗法的看法和评价， 关于老年西班牙裔/拉丁裔参与临床试验的障碍、促进者和优先事项 迄今为止，在临床试验中代表性不足的患者。在这份提案中，我们专注于西班牙裔/ 墨西哥裔的拉丁裔，因为这一人群代表了美国西班牙裔/拉丁裔的最大比例。 从概念上讲，为了参与医学研究或临床试验，个人必须有能力， 参与的机会和动机。增加老年西班牙裔/拉丁裔成人在临床中的代表性 在试验中，识别参与的动机因素和障碍是关键。这些信息只能是 使用定性研究设计获得，如焦点小组或访谈。因此，我们建议进行 焦点小组与老年人自我认同为西班牙裔/拉丁裔墨西哥人，以引出对 新医学疗法的临床试验，重点是参与的感知障碍和促进因素。 重要的是，我们将调查对拟议的新临床试验设计的看法，例如数字技术的使用 接口、社区站点和家庭访视，我们将从社区站点和临床站点招募 和焦点小组将在社区环境中或通过电话以英语或西班牙语进行 与会者喜欢的语言。我们的工作很可能会产生新的信息， 医疗保健研究人员或系统可以解决老年墨西哥裔美国人参与研究的障碍; 以及2）优选格式（例如，口头、书面），进行研究的地点，以及 信息，可接受的测试类型，以及3）参与的激励因素。