CLINICAL TRIALS UNIT

描述(取自应用程序) 这项提议的目标是建立一个临床试验股(CTU) 在查尔斯·R·德鲁医学和科学大学(德鲁) 与美国国立卫生研究院(NIH)的合作将 促进发展，增加培养的核心师资队伍 在临床调查、行为科学和流行病学方面。德鲁是 其独特之处在于，它所关心的文化多样性社区包括 拉美裔(约65%)、黑人(约25%)和亚洲/太平洋岛民/白人(约10%)， 因心血管疾病而死亡率不成比例的人(和 相关)疾病、糖尿病、癌症、事故和故意伤害， 消化系统疾病、婴儿死亡率、艾滋病毒/艾滋病和药物使用/滥用。 德鲁反恐组将专注于招募妇女和服务不足的人群 在这些领域中的许多领域，仍然是一项尚未得到满足的挑战。CTU还将 作为促进妇女参与的跨学科模式 以及临床试验中服务不足的人群。一种独特的生物行为核心 在CTU内部将检查和评估文化，心理和 社会经济差异对传统实施方法的影响 旨在改善获得和提供保健服务的临床试验。 反恐股的实施将分为两个阶段。第一阶段(12个月) 将专注于发展研究基础设施，以包括招聘 中心主任、其管理员和研究护士的名单 协调员。与一个国家咨询委员会合作，该委员会由 作为NIH的候任人选，CTU主任将确定并开发一种临床试验 研究项目。第二阶段(60个月)将开始实施 临床试验、教师发展和先导研究项目。这个 第二阶段的具体目标是：a)开发和/或招募创新人才 流行病学、心理社会和生物医学临床试验，强调 那些解决对女性影响特别大的医疗保健问题的机构 和服务不足的人口；b)创造可繁殖的文化和 对社会经济敏感的战略，以增加招聘和 在临床试验中保留；c)创造可重复的文化和 社会经济敏感评估工具用于验证 临床试验中的反应/结果；d)增加指导关系 有经验的临床研究人员和德鲁大学初级教员之间的合作；以及 E)增加NIH、公共卫生服务(PHS)的数量， 在德鲁，私人资助和行业赞助的临床试验。

DESCRIPTION (taken from the application) The objective of this proposal is to establish a Clinical Trials Unit (CTU) at the Charles R. Drew University of Medicine and Science (Drew) in cooperation with the National Institutes of Health (NIH) that will facilitate the development and increase the number of core faculty trained in clinical investigation, behavioral science, and epidemiology. Drew is unique in that the culturally diverse community it cares for includes Hispanics (~65%), Blacks (~25%), and Asian/Pacific Islander/White (~10%), who suffer from a disproportionate mortality rate due to cardiovascular (and related) diseases, diabetes, cancer, accidents and intentional injuries, digestive diseases, infant mortality, HIV/AIDS, and substance use/abuse. The Drew CTU will focus on recruitment of women and underserved populations in many of these areas which remain an unmet challenge. The CTU will also serve as an interdisciplinary model for enhancing the participation of women and underserved populations in clinical trials. A unique Biobehavioral Core within the CTU will examine and evaluate how cultural, psychological, and socioeconomic differences impact on traditional methods used to implement clinical trials designed to improve access to and delivery of health care. The CTU implementation will be divided into two phases. Phase I (12 months) will focus on developing research infrastructure to include the recruitment of the Center Director, his/her administrator and research nurse coordinator. In conjunction with a national advisory committee, chaired by a NIH designate, the CTU Director will identify and develop a clinical pilot research project. Phase II (60 months) will begin the implementation of clinical trials, faculty development and the pilot research project. The specific aims of phase II are to: a) develop and/or recruit innovative epidemiological, psycho-social, and biomedical clinical trials, emphasizing those that address health care issues that disproportionately affect women and underserved populations; b) create reproducible culturally and socioeconomically sensitive strategies for increasing recruitment and retention in clinical trials; c) create reproducible culturally and socioeconomically sensitive assessment tools for validating the responses/outcomes in clinical trials; d) increase mentoring relationships between experienced clinical investigators and junior faculty at Drew; and e) increase the number of NIH, Public Health Service (PHS), privately-funded, and industry-sponsored clinical trials at Drew.