Core C: Clinical and Population Sciences Core

有关艾滋病毒疾病的临床影响研究最终需要直接调查高危或 感染艾滋病毒的人群。这种以人体为对象的研究广泛地包括，例如， “从床到床”转化研究、观察性数据库衍生研究、前瞻性队列研究 调查、实验工作和实施科学。这些研究的每一个学科都是 复杂，需要在最高级别进行大量的基础设施建设。其中一些 学科，如翻译研究，需要在几个方面进行相当大的协调 方法论和实质性领域。支持临床上有影响力的研究，特别是那些 是翻译性的，UCSF-Gladstone CFAR临床和人口科学的总体目标 核心是整合流行病学的人类受试者研究方法学科和 生物统计学与艾滋病毒感染的基础和临床实质性科学，以方便人类受试者- 以艾滋病毒相关研究为基础。因此，具体目标是： 目标1：通过以下途径提供与艾滋病毒/艾滋病研究有关的临床和人口科学方面的专门知识 关于研究问题的概念、研究设计、数据来源、数据的咨询 数据的管理、生物统计分析和解释； 目标2：管理旧金山和旧金山两地感染艾滋病毒的成年人的独特前瞻性观察队列 (范围和选项)和非洲(UARTO和ISS临床队列)，为研究人员提供 来自具有良好特征的受试者的各种数据和生物样本阵列 流行病学、临床、实验室和行为参数的术语； 目标3：为新提出的预期人体受试者研究提供一个有效进行的平台； 目标4：在涉及人类受试者的研究中指导早期研究人员。 提供这些服务的核心机制的基本原理是为多个研究人员提供 成本效益高的集中化资源，以其他方式无法通过传统资金来源获得。 核心办法在当前供资周期中的效用的证据包括分配超过 24000个生物标本样本，支持243个项目和296个核心用户(包括124个早期用户 阶段调查员)，并在过去4年为184份出版物提供便利。在这项拟议的更新中， 在国内和国际的支持下，核心的中心职能将保持不变 研究，但根据机构优势，计划增加几个新的内容和重点 加州大学格拉德斯通分校，国立卫生研究院赞助的主要艾滋病毒/艾滋病项目的议程，以及研究 由当地CFAR调查人员发起的倡议。

Clinically impactful research regarding HIV disease ultimately requires direct investigation of at-risk or HIV-infected human populations. Such human subjects-based research broadly includes, for example, “bench to bedside” translational research, observational database-derived research, prospective cohort investigation, experimental work, and implementation science. Each of these research disciplines is sophisticated, requiring substantial infrastructure to pursue at the highest level. Some of the disciplines, such as translational research, require considerable coordination across several methodologic and substantive domains. To support clinically impactful research, particularly that which is translational, the overall objective of the UCSF-Gladstone CFAR Clinical and Population Sciences Core is to integrate the human subjects research methodologic disciplines of epidemiology and biostatistics with the basic and clinical substantive science of HIV infection to facilitate human subjects- based HIV-related research. Accordingly, the specific aims are to: Aim 1: Provide expertise in the clinical and population sciences related to HIV/AIDS research via consultation regarding conception of research questions, study design, sources of data, data management, biostatistical analysis, and interpretation of data; Aim 2: Manage unique prospective observational cohorts of HIV-infected adults in both San Francisco (SCOPE and Options) and Africa (UARTO and ISS Clinic Cohorts) that provide researchers with a diverse array of data and biological specimens from subjects who are well-characterized in terms of epidemiologic, clinical, laboratory and behavioral parameters; Aim 3: Offer a platform for the efficient conduct of newly proposed prospective human subjects studies; Aim 4: Mentor early stage investigators in the conduct of research involving human subjects. The rationale for a core mechanism to offer these services is to provide multiple researchers with a cost-efficient centralized resource that is not otherwise available through traditional funding sources. Evidence of the utility of the Core's approach in the current funding cycle includes distribution of over 24,000 biological specimen samples, support of 243 projects and 296 core users (including 124 early stage investigators), and facilitation of 184 publications in the past 4 years. In this proposed renewal, the central functions of the Core will be unchanged, with support of both domestic and international research, but several new additions and emphases are planned based on the institutional strengths at UCSF-Gladstone, the agendas of major NIH-sponsored HIV/AIDS programs, and the research initiatives being launched by local CFAR investigators.