Idiopathic Pulmonary Fibrosis Clinical Research Network

描述（由申请人提供）： 美国国家心肺血液研究所（NHLBI）提出了一项创建临床研究网络（CRN）的倡议，其目标是有效地进行随机试验，以改善新诊断的特发性肺纤维化（IPF）患者的临床结局。 CRN将由6至7个临床中心和1个数据协调中心（DCC）组成。 该网络将进行一系列临床试验，评估新的和已建立的药物和疗法。 杜克临床研究所（DCRI）拟担任该网络的DCC。 在这个角色中，DCRI将协调和管理CRN的临床研究和组织活动。 利用我们丰富的研究经验和基础设施，我们将协助制定研究方案，监测数据收集活动和临床中心的方案特定培训。 我们已经组建了一个由生物统计学、肺医学、卫生经济学和生活质量专家组成的团队，以确保能够得出科学上有依据和有临床意义的结论。 我们将通过各种各样的接口，包括基于网络的技术，国家肺和健康成果会议，以及科学出版物，促进CRN的进展。 为实现IPF-CRN的目标，DCRI将重点开展以下活动：（1）研究协调和规划，（2）数据管理和报告活动，（3）试验设计和方案制定，（4）数据分析，以及（5）结果的发布和传播。 (End摘要）

DESCRIPTION (provided by applicant): The National Heart, Lung, and Blood Institute (NHLBI) has proposed an initiative to create a Clinical Research Network (CRN) with the goal of efficiently conducting randomized trials to improve clinical outcomes for patients with newly diagnosed idiopathic pulmonary fibrosis (IPF). The CRN will be structured to have 6 to 7 clinical centers and one data coordinating center (DCC). The network will conduct a series of clinical trials evaluating new and established drugs and therapies. The Duke Clinical Research Institute (DCRI) proposes to serve as the DCC for the network. In this role, the DCRI will coordinate and manage the clinical research and organizational activities of the CRN. Using our extensive research experience and infrastructure, we will assist in developing study protocols, monitoring data collection activities, and protocol-specific training of clinical centers. We have assembled a team of experts in biostatistics, pulmonary medicine, health economics, and quality of life to ensure that scientifically defensible and clinically meaningful conclusions can be drawn. We will promote the progress of the CRN through a wide variety of interfaces including web-based technologies, national pulmonary and health outcomes meetings, and scientific publications. To achieve the objectives of the IPF-CRN, the DCRI will focus on the following activities: (1) study coordination and planning, (2) data management and reporting activities, (3) trial design and protocol development, (4) data analysis, and (5) publication and dissemination of results. (End of Abstract)