Transfusion Medicine/Hemostasis Clinical Research Networ

描述(由申请者提供)：通过这项申请，埃默里大学输血医学计划寻求成为拟议网络中的核心临床中心。作为核心临床中心，我们将促进科学概念和方案的制定；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；遵守与人体受试者研究相关的国家和机构指南和法规要求；让符合条件的患者参加由该网络选择进行的试验；并通过及时的出版物和数据演示来传播研究结果。与TM/止血相关的复杂而重要的研究问题需要临床研究来评估发展概念，并通过大规模的对照试验对新策略进行最终测试，从而有必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)调查输血医学实践中的重要问题；2)评估儿科和成人环境中止血和血液疾病的新管理策略；3)建立计划基础设施和系统，以确保多学科、多中心的互动、数据质量/分析以及高效、及时的试验收益。在这份提案中，我们提供了我们在多中心临床试验中的机构和个人专业知识的证据，以及与相关患者群体接触的记录、采集和输注的血液/血液产品的数量，以及核心临床中心的多学科互动。通过纳入两个拟议的模型临床方案，我们提供了进一步的证据，这两个方案都是随机试验，调查输血医学和止血方面的重要临床问题。多学科研究人员的专业知识；能够接触到大量有可能有资格进行输血医学和/或止血前瞻性研究的病例；出色的临床试验实施和数据管理组织；为可能的试验开发提出的创新理念；以及在输血医学、止血和血栓形成领域的国家领先地位，这些都是埃默里大学努力成为NHLBI临床网络在TM/止血领域的核心成员的基础。

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.