Transfusion Medicine/Hemostasis Clinical Trails Network

描述(由申请人提供) 本提案是为了响应RFA-HL-06-108关于输血医学/止血临床研究网络继续开展的有限竞争的要求而提交的，该网络是一个由互动式临床研究小组组成的全国性网络。通过这项申请，埃默里大学的输血医学项目寻求继续作为网络中的核心临床中心提供资金。作为一个核心临床中心，我们已经并将继续致力于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整体管理；遵守与人体研究相关的国家和机构指南和法规要求；吸引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展示来传播研究结果。作为临床研究网络的核心临床中心，我们将继续追求以下具体目标：1)维持并根据需要进一步发展结构，以支持输血医学和止血领域的临床试验的开发、实施和进行。这将与新英格兰研究院作为数据协调中心和NHLBI的项目工作人员合作完成；2)利用工作和研究监督小组委员会的结构，完成正在进行的试验，并开发、改进和完成本申请中建议的新试验；3)发展合作关系和支持培训机会，以促进拟议的临床试验的成功，并促进输血医学和止血领域的进一步发展。在过去的5年里，埃默里大学的研究人员积极参加指导委员会的会议，招募患者参加PLADO试验，获得IRB对SHIP的批准，并继续努力获得IRB对RICH试验的批准。埃默里核心临床中心已经制定了人员和程序，以确保最佳的参与和未来的生产力。

DESCRIPTION (provided by applicant) This proposal is submitted in response to RFA-HL-06-108 for the Limited Competition for the Continuation of the Transfusion Medicine /Hemostasis Clinical Research Network, a nationally developed network of interactive clinical research groups. With this application, the Transfusion Medicine Program at Emory University seeks to continue funding as a Core Clinical Center within the Network. As a Core Clinical Center we have and will continue to contribute scientific concepts and to 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. As a Core Clinical Center of the Clinical Research Network we will continue to pursue the following Specific Aims, to: 1) maintain, and further develop, as needed, a structure to support the development, implementation and conduct of clinical trials in the areas of transfusion medicine and hemostasis. This will be done in collaboration with the New England Research Institutes as Data Coordinating Center, and program staff at NHLBI; 2) utilizing a structure of working and study oversight subcommittees, complete ongoing trials and develop, refine and complete new trials proposed in this application; 3) develop collaborative relationships and support training opportunities to facilitate the success of the proposed clinical trials and further the fields of transfusion medicine and hemostasis. Over the past 5 years, Emory University investigators have actively participated at Steering Committee meetings, enrolled patients on the PLADO trial, obtained IRB approval for SHIP, and continued to work on obtaining IRB approval for the RICH trial. The Emory Core Clinical Center has developed the personnel and procedures to ensure optimal participation and future productivity.