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[Using Real World Data in Cancer Clinical Studies].

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Real-world data (RWD) is crucial for oncology drug development. Japanese DPC data has limitations for evaluating patient background and drug efficacy, unlike US EMR-derived RWD which collects essential oncology information.

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Area of Science:

  • Oncology
  • Health Informatics
  • Data Science

Background:

  • Growing demand for real-world data (RWD) in oncology drug and medical device development.
  • Japanese RWD landscape includes EMR, DPC, claims, and registry data.
  • Existing DPC databases offer limited data items, potentially hindering comprehensive analysis.

Purpose of the Study:

  • To evaluate the suitability of Japanese RWD sources for oncology research.
  • To compare the data richness of Japanese DPC databases with US EMR-derived RWD.
  • To highlight the importance of database selection and quality assessment in cancer RWD utilization.

Main Methods:

  • Comparative analysis of data availability in Japanese DPC databases versus US Flatiron Health EMR data.
  • Assessment of data item limitations in DPC for evaluating patient background, drug efficacy, and safety.
  • Review of methodologies for collecting structured clinical data in oncology.

Main Results:

  • Japanese DPC databases exhibit limitations in capturing essential patient background and drug evaluation data.
  • US EMR-derived RWD, exemplified by Flatiron Health, demonstrates a more comprehensive approach to oncology data collection.
  • Cancer-specific EMR systems and expert data curation enhance RWD quality.

Conclusions:

  • Careful selection of RWD databases is critical for oncology research, based on specific analytical needs.
  • Understanding database quality variations is essential for reliable real-world evidence generation.
  • US EMR-derived RWD models offer a more robust framework for oncology clinical research compared to current Japanese DPC data.