Strengthening the Operating Framework and Furthering the Objectives of CFAST

强化CFAST运营框架，推进CFAST目标

• 批准号: 9109478
• 负责人: Enrique Eduardo Aviles
• 金额: $ 70万
• 依托单位: CRITICAL PATH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-15 至 2016-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9109478
• 关键词: Strengthening; Operating; Framework; Furthering; Objectives

CFAST Project Summary The FDA CDER Data Standards Strategy calls for the development, implementation, and maintenance of comprehensive clinical data standards to facilitate the efficient and effective review of regulatory submissions. For this project, the CFAST founding partners, C-Path and CDISC, will collaborate to perform four specific aims: 1) Maintenance of the scientific and administrative infrastructure of the CFAST public- private partnership to support a series of projects under the CFAST Initiative. 2) Identification and engagement with key experts in specific therapeutic areas, including stakeholders from industry, professional organizations, academia, and government agencies, and coordination and management of therapeutic area standards development projects with those experts. 3) Development of two new therapeutic area data standards for Major Depressive Disorder and Kidney Transplant Products, as well as completing three data standards that are in- process from the previous award (diabetic kidney disease, CV imaging and rheumatoid arthritis). Additionally two new therapeutic area data standards may be started but not completed during the award period (Parkinson's v2.0 and Duchenne Muscular Dystrophy). 4) Identification and implementation of continuous quality improvements with respect to the data standards development process and products to facilitate timely and sustainable standards to include integrating the use of an electronic repository of standards components and metadata early in the development process, i.e. the CDISC Shared Health and Clinical Research Electronic (SHARE) library. CFAST Relevance The FDA Center for Drug Evaluation and Research (CDER) receives an enormous and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. The lack of standardization creates significant challenges to realizing the potential those data have to advance CDER's regulatory and scientific work. Continuing the efforts to establish common standards for data reporting will provide opportunities to transform massive amounts of data from drug studies on specific diseases into useful information to potentially speed the delivery of new therapies to patients.

CFAST项目总结 FDA CDER数据标准战略要求制定、实施和 维持全面的临床数据标准，以促进有效率和有成效的 审查监管申报资料。在这个项目中，CFAST创始合伙人C-Path和 CDISC将合作实现四个具体目标： 1)维护CFAST公共科学和行政基础设施， 与私营伙伴合作，支持CFAST倡议下的一系列项目。 2)确定并与特定治疗领域的关键专家接触，包括 来自行业、专业组织、学术界和政府的利益相关者 机构，以及治疗领域标准的协调和管理 与这些专家合作开发项目。 3)重性抑郁症两个新治疗领域数据标准的制定 和肾移植产品，以及完成三个数据标准，在- 上一个奖项的过程（糖尿病肾病，CV成像和类风湿 关节炎）。此外，可能会启动两个新的治疗领域数据标准，但 在奖励期内完成（帕金森病2.0版和杜氏肌肉 营养不良）。 4)确定和实施与以下方面有关的持续质量改进： 数据标准开发过程和产品，以促进及时和可持续的 标准，包括整合使用电子标准库 在开发过程的早期，即CDISC共享 健康和临床研究电子图书馆（SHARE）。 CFAST相关性 FDA药物评价和研究中心（CDER）收到了巨大的和不断增长的 来自多个来源的各种监管提交文件中的大量数据， 多种格式。缺乏标准化对实现 这些数据有可能推动CDER的监管和科学工作。继续 建立数据报告共同标准的努力将提供机会， 从特定疾病的药物研究中获得大量数据， 这可能会加速新疗法向患者的输送。