Strengthening the Operating Framework and Furthering the Objectives of CFAST

CFAST项目总结 FDA CDER数据标准战略要求制定、实施和 维护全面的临床数据标准，促进高效有效 审查监管提交的文件。对于这个项目，CFAST的创始合作伙伴C-Path和 CDISC将合作实现四个具体目标： 1)维护CFAST公众的科学和行政基础设施-- 私营伙伴关系，以支持CFAST倡议下的一系列项目。 2)确定具体治疗领域的主要专家并与之接触，包括 来自工业界、专业组织、学术界和政府的利益相关者 机构，以及治疗区域标准的协调和管理 与这些专家一起开展开发项目。 3)制定两个新的重度抑郁障碍治疗区域数据标准 和肾脏移植产品，以及完成三个数据标准，这三个标准是- 上一个奖项的过程(糖尿病肾脏疾病、心血管成像和类风湿 关节炎)。此外，两个新的治疗区域数据标准可能会启动，但不会 在获奖期内完成(帕金森氏v2.0和杜兴肌肉 营养不良)。 4)确定并实施关于以下方面的持续质量改进 数据标准开发流程和产品，以促进及时和可持续 标准应包括综合使用电子标准储存库 开发过程早期的组件和元数据，即CDISC共享 健康与临床研究电子(共享)图书馆。 CFAST相关性 FDA药物评价和研究中心(CDER)收到了巨大的且不断增长的 来自多种来源的各种监管提交文件中的数据量 各种格式。缺乏标准化给实现 这些数据可能会推动CDER的监管和科学工作。继续 为数据报告建立共同标准的努力将提供转变的机会 将特定疾病的大量药物研究数据转化为有用的信息 有可能加快向患者提供新疗法的速度。

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.