CLINICAL TRIALS UNIT

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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.