CLINICAL TRIALS UNIT

描述（取自应用程序） 本提案的目的是建立一个临床试验单位（CTU） 在Charles R。德鲁医学和科学大学（德鲁） 与美国国立卫生研究院（NIH）合作， 促进发展和增加培训的核心教师人数 在临床调查、行为科学和流行病学方面。 德鲁是 独特之处在于它所关心的文化多样性社区包括 西班牙裔（~65%）、黑人（~25%）和亚洲/太平洋岛民/白色（~10%）， 他们因心血管疾病（以及 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。 德鲁反恐小组将重点招聘妇女和服务不足的人口 在许多领域，这仍然是一个尚未解决的挑战。 反恐组还将 作为加强妇女参与的跨学科模式 和服务不足的人群进行临床试验。 独特的生物行为核心 反恐组内部将审查和评估文化，心理， 社会经济差异对传统方法的影响 临床试验旨在改善获得和提供卫生保健。 反恐组的实施将分为两个阶段。 第一阶段（12个月） 将重点发展研究基础设施，包括招聘 中心主任、其管理人员和研究护士 协调员很 与国家咨询委员会一道， 作为NIH的指定人员，CTU主任将确定并开发一个临床试验项目 研究项目。 第二阶段（60个月）将开始执行 临床试验、教师发展和试点研究项目。 的 第二阶段的具体目标是：（a）发展和/或征聘创新的 流行病学，心理社会和生物医学临床试验，强调 那些解决对妇女影响特别大的保健问题的方案 和服务不足的人群; B）创造可再生的文化和 对社会经济问题敏感的增加征聘战略， 保留在临床试验中; c）创造可复制的文化和 社会经济敏感的评估工具， 临床试验中的反应/结果; d）增加指导关系 经验丰富的临床研究人员和德鲁的初级教师之间; （e）增加国家卫生研究院、公共卫生服务处、 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.