Transfusion Medicine/Hemostasis Clinical Research Networ

描述（由申请人提供）：通过此申请，埃默里大学输血医学项目寻求成为拟议网络中的核心临床中心。作为核心临床中心，我们将为科学理念和方案开发做出贡献；通过国家指导委员会和数据协调中心参与临床试验的全面管理；遵守与涉及人类受试者的研究相关的国家和机构指南和监管要求；使符合条件的患者参加由网络选择进行的试验；并通过及时的出版物和数据展示来传播研究结果。与TM/止血相关的复杂而重要的研究问题需要临床研究通过对新策略的最终测试来评估发展概念，并通过大规模的对照试验与标准治疗相比较，这就需要开发这样一个拟议的网络。作为临床研究网络的核心临床中心，我们将追求以下具体目标：1)研究输血医学实践中的重大问题；2)评估儿科和成人止血和血液疾病的新管理策略；3)建立程序化的基础设施和系统，以确保多学科、多中心的互动、数据质量/分析以及有效、及时的试验积累。在本提案中，我们提供了我们在多中心临床试验方面的机构和个人专业知识的证据，以及相关患者群体的获取记录，收集和输注的血液/血液制品量，以及核心临床中心的多学科互动。我们的专业知识通过纳入两个拟议的模型临床方案提供了进一步的证据，这两个模型临床方案都是随机试验，研究输血医学和止血方面的重要临床问题。多学科研究者的专业知识；获得大量可能符合输血医学和/或止血前瞻性研究条件的病例；优秀的临床试验实施组织和数据管理能力；发展可能的试验的创新概念；在输血医学以及止血和血栓形成方面的国家领导地位为埃默里大学作为NHLBI临床网络的核心成员参与TM/止血提供了基础。

DESCRIPTION (provided by applicant): With this application, the Transfusion Medicine Program, Emery University seeks to become a Core Clinical Center within the proposed network. As a Core Clinical Center, we will contribute scientific concepts and protocol development; participate in the overall administration of the clinical trials through the national Steering Committee and Data Coordinating Center; adhere to national and institutional guidelines and regulatory requirements related to research involving human subjects; accrue eligible patients to trials selected to be conducted by the Network; and disseminate findings through timely publications and presentations of data. The complex and significant research questions related to TM/hemostasis require clinical studies to evaluate developmental concepts through to ultimate testing of new strategies compared to the standard-of-care through large-scale, controlled trials, necessitating the development of such a proposed network. As a Core Clinical Center of the Clinical Research Network we will pursue the following Specific Aims, to: 1) investigate significant questions in transfusion medicine practice; 2) evaluate novel management strategies in hemostatic and hematologic disorders in both pediatric and adult settings; and 3) establish the programmatic infrastructure and systems to ensure multidisciplinary, multi-center interactions, data quality/analysis, and efficient, timely accrual to trials. In this proposal we provide evidence of our institutional and individual expertise in multi-center clinical trials, as well as documentation of access to relevant patient populations, volume of blood/blood products collected and infused, and multidisciplinary interaction in the Core Clinical Center. Further evidence of our expertise is provided through the inclusion of two proposed model clinical protocols, both randomized trials, investigating important clinical questions in transfusion medicine and hemostasis. The expertise of the multidisciplinary investigators; access to significant numbers of cases with conditions that potentially would be eligible for prospective studies in Transfusion Medicine and/or Hemostasis; excellent organization for clinical trial implementation and data management; innovative concepts for development of possible trials; and national leadership in Transfusion Medicine as well as hemostasis and thrombosis provide the basis for Emery University's efforts to participate as a core member of the NHLBI clinical network in TM/Hemostasis.