Core--Biostatistics & Data Management Facility

为支持CFAR调查人员，该中心将提供生物统计学、统计遗传学、生物医学信息学和数据协调方面的专门知识。继续进行核心研究将使研究人员持续获得成功的基础、翻译和临床艾滋病毒/艾滋病相关研究所必需的服务。在最初的五年中，该中心提供了：1)研究设计和分析的生物统计学支持；2)数据协调和生物医学信息学支持。数据协调和信息学活动产生了最先进的临床核心队列登记(HIV+患者)和数据仓库--HIV+患者的中央数据存储库，其中包含来自许多来源的重要科学数据，包括宾夕法尼亚大学卫生系统。主要的核心延续目标将是：(1)协助调查人员充分利用CFAR信息基础设施(例如，来自数据仓库的数据)来开发 临床研究项目和建议概念以及(2)提供广泛的生物统计学支持，包括用于综合研究设计和分析的统计遗传学。这一范例已被非常成功地用于在宾夕法尼亚大学增加由美国国立卫生研究院赞助的高质量艾滋病毒/艾滋病相关研究，包括预防临床试验。基础和临床研究的生物统计学特定目标是：i)就研究设计问题提供建议；ii)(重新定义和/或 这些研究包括：完善研究假设；iii)进行样本量/威力分析；iv)进行统计分析；v)协助准备最终报告、摘要、手稿和未来的研究建议；vi)进行探索性分析，以可能导致新的假设的产生。将通过集中接触生物统计联合调查员来促进导致转化性研究的合作，他们将就研究设计和分析提供咨询；最终将积极的基础科学成果引起临床研究人员的注意。数据协调和信息学的具体目标是：i)提供信息学专业知识，帮助调查人员探索提案的仓库数据(例如，将现有患者组合到符合拟议资格标准的队列中)；ii)设计提案的数据收集工具、管理和数据库。该核心将通过与调查人员协商，制定数据收集和管理的标准化方法，同时强调有必要遵守适用的FDA和ICH(国际协调会议)指南，从而提高研究质量。通过保证研究以符合监管要求的方式进行，将鼓励行业合作和资金投入。

In support of CFAR investigators, the Core will provide biostatistical, statistical genetics, biomedical informatics and data coordination expertise. The Core continuation will provide ongoing centralized investigator access to services essential to successful basic, translational, and clinical HIV/AIDS-related research. During the first five years, the Core provided: 1) biostatistical support of study design and analysis and 2) data coordination and biomedical informatics support. Data coordination and informatics activity yielded a state-of-the-art Clinical Core Cohort Registry (HIV+ patients) and Data Warehouse - a centralized data repository for HIV+ patients that contains vital scientific data from many sources, including the UPENN Health System. The overarching Core continuation goals will be to (1) assist Investigators with fully utilizing CFAR informatics infrastructure (e.g., data from the Data Warehouse) to develop clinical research project and proposal concepts and (2) provide a wide range of biostatistical support, including statistical genetics for comprehensive study design and analysis. This paradigm has been utilized very successfully to increase high quality NIH-sponsored HIV/AIDS-related research at UPENN, including prevention clinical trials. Biostatistical specific aims for basic and clinical research are to i) advise on study design issues; ii) (re)define and/or refine study hypotheses; iii) conduct sample size/power analyses; iv) conduct statistical analyses; v) assist with preparation of final reports, abstracts, manuscripts, and future research proposals; and vi) conduct exploratory analyses that may lead to generation of new hypotheses. Collaborations resulting in translational research will be fostered through centralized access to biostatistics co-investigators who will consult on study design and analysis; eventually bringing positive basic science results to the attention of clinical researchers. Data coordination and informatics specific aims are: i) provide informatics expertise to help investigators explore Warehouse data (e.g., assemble existing patients into cohorts meeting proposed eligibility criteria) for proposals and ii) design data collection instruments, management, and databases for proposals. The Core will contribute to research quality by consulting with investigators to develop standardized methodologies for data collection and management, while emphasizing the necessity for compliance with applicable FDA and ICH (International Conference for Harmonization) guidelines. Industry collaboration and funding will be encouraged through assurances that research is conducted in a manner consistent with regulatory requirements.