Re-Engineering the Clinical Research Enterprise

重新设计临床研究企业

• 批准号: 7058410
• 负责人: Carol D Hamilton
• 金额: --
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2007-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7058410
• 关键词: Internet; clinical research; health science research support; interdisciplinary collaboration; tuberculosis

The major focus of this project is to enhance the willingness and capacity for clinics within the U.S. public health system to engaged in clinical research. Though our specific long-term goal is progress toward worldwide TB control and elimination, the products we develop will have broad application among clinical research networks in the U.S. We will accomplish our goals by collaborating with an established academic research organization, the Duke Clinical Research Institute (DCRI), using their infrastructure, their clinical trials expertise and tools, and their established and developing training programs. The TBTC-DCRI collaboration will: Engage public health leaders in the clinical research enterprise in general, and TB clinical research in particular, by investing them in priority-setting forums that will also help the TBTC to create a relevant, timely and dynamic future scientific agenda. Identify and reduce barriers to clinical trials research in U.S. public health clinics. Develop, with public health leaders and networks engaged in multicenter trials, a model for improving the process of human subjects protection review in multicenter trials. Create an interoperable, secure web-based electronic data capture system for the TBTC, that will interface with public health surveillance systems.

该项目的主要重点是增强美国公共卫生系统内诊所从事临床研究的意愿和能力。虽然我们具体的长期目标是在全球控制和消除结核病方面取得进展，但我们开发的产品将在美国的临床研究网络中得到广泛应用。我们将通过与成熟的学术研究组织杜克临床研究所合作来实现我们的目标(DCRI)，利用其基础设施、临床试验专业知识和工具以及已建立和正在开发的培训计划。 TBTC-DCRI 合作将： 通过让公共卫生领导者参与临床研究企业，特别是结核病临床研究，让他们参与确定优先事项的论坛，这也将有助于 TBTC 创建相关、及时和动态的未来科学议程。 识别并减少美国公共卫生诊所临床试验研究的障碍。 与参与多中心试验的公共卫生领导者和网络一起开发一个模型，以改进多中心试验中人类受试者保护审查的过程。 为 TBTC 创建一个可互操作、安全的基于网络的电子数据采集系统，该系统将与公共卫生监测系统连接。