CDISC治疗领域标准提高临床研究效率

CDISC therapeutic area standards enhance the efficiency of clinical researches

临床数据交换标准协会(Clinical Data Interchange Standards Consortium,CDISC)建立了一系列临床研究数据标准,用于支持临床及临床前研究数据的电子获取、交换、递交和归档。为了更好地促进临床相关治疗领域中临床研究数据标准化,CDISC发起成立了促进标准与治疗领域开发联盟(Coalition for Accelerating Standards and Therapies,CFAST)。CFAST旨在通过减少临床研究实施所需的时间和资源、提高研究数据质量并促进数据集成来加快创新疗法的发展。治疗领域(therapeutic area,TA)标准是针对特定疾病领域对CDISC基础标准的扩展。TA标准的内容可以覆盖临床试验从开始设计到研究数据递交/研究结果发布整个流程,其应用能增加临床研究的效率、加快监管决策速度、促进不同试验和队列数据的二次分析。

Clinical Data Interchange Standards Consortium （CDISC） has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical research data. Coalition for Accelerating Standards and Therapies （CFAST） is an initiative of CDISC to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health. CFAST aims to accelerate the development of innovative therapies by reducing the time and resources required for study conduct and increasing the quality and facilitating integration of research data. CDISC Therapeutic Area （TA） Standards are extensions of the foundational standards, in that they extend the foundational standards to cover specific disease areas. TA Standards pertain to the general conduct of the life-cycle of clinical research protocol to data submission/report. The use of this standard brings about the possibility of increasing the efficiency of clinical research, enhancing the pace of regulatory decisions, and facilitating secondary analyses of separate trials and cohorts.