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Special Section: A Collection of Articles on Opportunities and Challenges in Utilizing Real-World Data for Clinical Trials and Medical Product Development

Editor’s Note: Special Section on a Collection of Articles on Opportunities and Challenges in Utilizing Real-World Data for Clinical Trials and Medical Product Development

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References

  • Chen, J., Ho, M., Lee, K., Song, Y., Fang, Y., Goldstein, B. A., He, W., Irony, T., Jiang, Q., van der Laan, M., Lee, H., Lin, X., Meng, Z., Mishra-Kalyani, P., Rockhold, F., Wang, H., and White, R. (2023), “The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis,” Statistics in Biopharmaceutical Research, this issue. DOI: 10.1080/19466315.2021.1883474.
  • Evans, S. R., and Hamasaki, T. (2022), “Weighing Evidence: Robustness vs Quantity,” JNCI: Journal of the National Cancer Institute, djac186. DOI: 10.1093/jnci/djac186.
  • Food and Drug Administration (FDA). (2017), “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” August 31, 2017. Available at https://www.fda.gov/media/99447/download (Accessed December 19, 2022).
  • Ho, M., van der Laan, M., Lee, H., Chen, J., Lee, K., Fang, Y., He, W., Irony, T., Jiang, Q., Lin, X., Meng, Z., Mishra-Kalyani, P., Rockhold, F., Song, Y., Wang, H., and White, R. (2023), “The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis,” Statistics in Biopharmaceutical Research, this issue. DOI: 10.1080/19466315.2021.1883475.
  • Levenson, M., He, W., Chen, J., Fang, Y., Faries, D., Goldstein, B. A., Ho, M., Lee, K., Mishra-Kalyani, P., Rockhold, F., Wang, H., and Zink, R. C. (2023), “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment,” Statistics in Biopharmaceutical Research, this issue. DOI: 10.1080/19466315.2021.1883473.
  • Ministry of Health and Welfare (MHLW). (1980), “Handling of Prescription Drugs in Insurance Medical Care,” (in Japanese). Available at https://www.ganjoho.org/knowledge/reference/55.pdf (accessed December 19, 2022).

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