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Study on applicability evaluation index system of real-world data
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Yao DU1, 2, Xiao-liang YUAN1, 3, Yu-wen CHEN1, 3
Chinese Journal of New Drugs | 2023, 32(16) : 1593 - 1599
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Chinese Journal of New Drugs | 2023, 32(16): 1593-1599
Study on applicability evaluation index system of real-world data
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Yao DU1, 2, Xiao-liang YUAN1, 3, Yu-wen CHEN1, 3
Affiliations
  • 1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2School of Medicine & Holistic Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, China
  • 3Drug Regulatory Research Base of NMPA/Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang 110016, China
Published: 2023-08-30
Outline
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Objective:

To establish a scientific applicability evaluation index system of real-world data (RWD), and provide a quantitative analysis basis for the transformation of RWD into real-world evidence (RWE).

Methods:

Hierarchical extraction analysis of factors affecting the applicability of RWD was carried out by studying domestic and international guides, documents and literature. Analytic hierarchy process (AHP) and group eigenvalue method (GEM) were used in combination to establish the hierarchical structures of the selected indicators, expert scoring matrix was constructed, and MATLAB software for index system was used to compute the weights.

Results:

Applicability evaluation index was constructed from two aspects: relevance and reliability. Relevance included five sub-criteria level indexes and 26 specific evaluation indicators: data source and sample, exposure/intervention and event outcome definition, integration of multi-source data, regulatory requirements, ethics. Reliability consisted of three sub-criteria level indexes and 27 specific evaluation indicators: data validity, quality control, and quality assurance.

Conclusion:

When gathering and applying RWD, attention should be paid to the data source, validity, and quality control, to ensure that the data is closely related to the demand and is reliable, and then to upgrade the applicability from RWD to RWE.

applicability evaluation  /  real-world data  /  evaluation index system
Yao DU, Xiao-liang YUAN, Yu-wen CHEN. Study on applicability evaluation index system of real-world data[J]. Chinese Journal of New Drugs, 2023 , 32 (16) : 1593 -1599 .
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Article Info
  • Online Date：2026-03-05
  • Published：2023-08-30
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History
  • Accepted：2023-01-10
Funding
Affiliations
    1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
    2School of Medicine & Holistic Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, China
    3Drug Regulatory Research Base of NMPA/Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang 110016, China
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光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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