Peng X X, Su J, Cai S Y, Peng R L, Peng Y G, Ma X L, Ni X
Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China Hainan Real World Data Research Institute, Haikou 571435, China.
Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2021 Dec 10;42(12):2201-2207. doi: 10.3760/cma.j.cn112338-20210629-00505.
Real world data (RWD) refers to the data generated in routine clinical practices, daily life, and real work environment and has been widely used in clinical or public health research. Still, issues related to the quality of RWD, such as incompleteness, inconsistency, and inaccuracy, would affect the validity of real-world research. To overcome the challenges due to the lack of standardization of real world source data, case report form based on clinical data interchange standards consortium (CDISC-CRF) on certain diseases was developed to promote the ecology construction of RWD based on the data standards set by the CDISC which has been widely used. Firstly, we described how to apply data standards to make up the gap between RWD and real world evidence. Then, the process was designed to build RWD ecology based on CDISC-CRF, in which the development technology of CDISC-CRF form is mainly introduced. Finally, the application prospect and significance of building real-world data based on disease-specific CDISC-CRF are described. It is believed that the present paper can provide a new idea for promoting the ecology construction of RWD in China.
真实世界数据（RWD）是指在常规临床实践、日常生活和实际工作环境中产生的数据，已广泛应用于临床或公共卫生研究。尽管如此，与RWD质量相关的问题，如不完整性、不一致性和不准确，会影响真实世界研究的有效性。为克服因真实世界源数据缺乏标准化带来的挑战，基于临床数据交换标准协会（CDISC）的数据标准，开发了针对某些疾病的基于CDISC病例报告表（CDISC-CRF），以促进RWD的生态建设，该标准已被广泛使用。首先，我们描述了如何应用数据标准来弥补RWD与真实世界证据之间的差距。然后，设计了基于CDISC-CRF构建RWD生态的流程，主要介绍了CDISC-CRF表单的开发技术。最后，阐述了基于特定疾病的CDISC-CRF构建真实世界数据的应用前景及意义。相信本文能为推动我国RWD生态建设提供新思路。
