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杜克大学综合镰状细胞中心(CSCC)的临床核心包括杜克和查佩尔山的北卡罗来纳州大学医学中心的设施、人员、科学资源和镰状细胞病(SCD)患者群体。CSCC目前有1,388名SCD患者,平均分布在儿童和成人人群中,其中812名患者患有SS纯合子SCD。此外,通过NC镰状细胞病联盟,我们能够利用NC的3,000名SCD患者中的更多患者进行研究活动。临床核心有四个主要任务,所有这些都需要全面和关怀病人的互动:(1)病人护理-教师和工作人员直接提供综合,国家的最先进的, 与患者服务中心协调,为中心患者及其家属提供全面的医疗保健服务。此外,核心确保每个患者都可以访问新的研究协议,因为它们变得可用。(2)中心间临床试验的支持和绩效。杜克大学综合临床中心致力于参与由综合镰状细胞中心网络进行的多中心临床试验,我们的临床核心将为此类合作研究提供基础设施。该中心在这些类型的试验中具有丰富的经验,并将提供数据协调员,与NHLBI统计和数据管理人员协调数据输入和分析。(3)其他临床研究的支持和执行-核心将支持和开展Duke-Escheriche Sickle Ceil中心每个研究者的临床研究活动。核心人员将帮助确定和招募适当的研究受试者,获得知情同意书,可靠的标本采集,准确的数据采集,以及负责任的非侵入性管理服务(4)支持基础和转化研究:核心人员将帮助确定适当的研究受试者,获得知情同意书,并获得血液和生物样本用于 基础研究,以及在IRB要求和批准的情况下提供必然的临床数据。临床核心包括两个组成机构的医生、中心学者、医生扩展人员、护士、社会工作者和数据协调员,每个站点都提供儿科和成人服务。因为他们与每一个研究对象保持着密切的关系,并且完全了解研究的进展情况。 核心工作人员处于理想的位置,以确保所有基于中心和多中心的研究项目的有效实施。领导层包括Russell Ware博士作为核心PI,尤金P. Orringer博士作为临床试验机构主任,确保患者护理质量。他们和临床科学家在核心定期会晤,作为内部咨询委员会(见行政核心)与中心主任。IAC作为一个论坛,鼓励中心内的合作,以及解决与个别研究方案的问题,使他们可以及时解决。
英文摘要
The Clinical Core of the Duke-UNC Comprehensive Sickle Cell Center (CSCC) comprises facilities, personnel, scientific resources, and sickle cell disease (SCD) patient populations at the medical centers of both Duke and University of North Carolina at Chapel Hill. The CSCC currently has 1,388 SCD patients evenly split between pediatric and adult populations, with 812 clients having SS homozygous SCD. In addition, through the NC Consortium for Sickle Cell Disease, we are able to draw upon even more of the 3,000 SCD patients in NC for our research activities. The Clinical Core has four primary missions all of which require comprehensive and caring patient interaction: (1) Patient Care - Faculty and staff directly provide integrated, state-of-the-art, and comprehensive health care services to Center patients and their families in coordination with the Patient Service Core. Further, the Core ensures that each patient has access to new research protocols as they become available. (2) Support and Performance of Inter-center Clinical Trials. The Duke-UNC Comprehensive Clinical Center is committed to participationin the multi-center clinical trials conducted by the Comprehensive Sickle Cell Center network and our Clinical Core will provide the infrastructurefor such collaborative studies. The Center has extensive experience in these types of trials and will provide data coordinators to coordinate data entry and analysis with the NHLBI Statistics and Data Management Staff. (3) Support and Performance of Other Clinical Research - The Core will support and conduct the clinical research activities of each of the individual investigators of the Duke-UNC Sickle Ceil Center. Core personnel will help identify and recruit appropriate study subjects, obtain informed consent, reliable specimen collection, accurate data capture, and responsible, non-intrusive administrative services (4) Support for Basic and Translational Research: Core personnel will help identify appropriate study subjects, obtain informed consent, and obtain blood and biologic samples for use in basic research studies, as well as to provide corollary clinical data where required and approved by the IRB. The Clinical Core includes physicians, the Center's Scholar, physician extenders, nurses, social workers, and data coordinators at both constituent institutions, and each site provides both pediatric and adult services. Because they maintain a close relationship with each study subject and are fully knowledgeable about the research being conducted, the Core staff is ideally positioned to ensure the effective implementation of all Center-based and multi-center research projects. Leadership includes Dr. Russell Ware as PI of the Core, and Dr. Eugene P. Orringer as UNC Site Director who ensure quality of patient care. They and the clinician-scientistsin the Core meet regularly as the Intemal Advisory Committee (see Administrative Core) with the Center Director. The IAC acts as a forum to encourage intra-Center collaboration as well as address issues with individual research protocols so they may be addressed in a timely manner.
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Realizing Effectiveness Across Continents with Hydroxyurea(REACH): A Phase I/II Pilot Study of Hyroxyurea for Children with Sickle Cell Anemia
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