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Research on the problems of real-world data and the measures to improve real-world data's quality
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Wan-ting LI1, 2, Jia-hui QIAO1, 2, Ling-quan MENG1, 2, Gui-yu LIAN1, 2, Zhe HUANG1, 2, Yu-wen CHEN1, 2
Chinese Journal of New Drugs | 2021, 30(13) : 1160 - 1163
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Chinese Journal of New Drugs | 2021, 30(13): 1160-1163
Research on the problems of real-world data and the measures to improve real-world data's quality
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Wan-ting LI1, 2, Jia-hui QIAO1, 2, Ling-quan MENG1, 2, Gui-yu LIAN1, 2, Zhe HUANG1, 2, Yu-wen CHEN1, 2
Affiliations
  • 1College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang 110016, China
Published: 2021-07-15
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Traditional clinical trials that are randomized and controlled have exposed some deficiencies in the process of long-term use, prompting a growing number of researchers to look at real-world evidence (RWE). As an important basis of real-world study (RWS), real-world data (RWD) determine whether the RWS is qualified for supervision and review of institutions with reliable RWE. There are some problems about RWD, including unstructured and fragmented data, poor accessibility, lack of standards to standardize data, research design that is not rigorous, failure to control the applicability of RWD, etc. These problems will greatly affect the quality of RWD. Aiming to resolve the above problems, this paper provides six suggestions in order to provide a reference to improve the quality of RWD, including strengthening the management of RWD in medical institutions, improving RWD sharing mechanism, standardizing RWD according to data standards in RWS, collecting RWD according to rigorous research design, defining the responsibilities of personnel related to RWD quality and strictly controlling the applicability of RWD.

real-world study  /  real-world evidence  /  real-world data  /  quality of data
李宛亭, 乔佳慧, 孟令全, 连桂玉, 黄哲, 陈玉文. 真实世界数据存在的问题与质量提升对策研究. 中国新药杂志, 2021 , 30 (13) : 1160 -1163 .
Wan-ting LI, Jia-hui QIAO, Ling-quan MENG, Gui-yu LIAN, Zhe HUANG, Yu-wen CHEN. Research on the problems of real-world data and the measures to improve real-world data's quality[J]. Chinese Journal of New Drugs, 2021 , 30 (13) : 1160 -1163 .
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Year 2021 volume 30 Issue 13
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  • Online Date：2026-10-30
  • Published：2021-07-15
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  • Accepted：2020-10-09
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Affiliations
    1College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
    2Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang 110016, China
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红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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