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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

Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment”: Is Real-World Evidence Real?

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Pages 18-19 | Received 11 Aug 2021, Accepted 12 Aug 2021, Published online: 27 Sep 2021

References

  • Bartlett, V.L., Dhruva, S.S., Shah, N.D., Ryan, P., and Ross, J.S. (2019), “Feasibility of Using Real-world Data to Replicate Clinical Trial Evidence,” JAMA Network Open, 2, e1912869. DOI: 10.1001/jamanetworkopen.2019.12869.
  • Franklin, J.M., Patorno, E., Desai, R.J., Glynn, R.J., Martin, D., Quinto, K., Pawar, A., Bessette, L.G., Lee, H., Garry, E.M., Gautam, N., and Schneeweiss, S. (2021), “Emulating Randomized Clinical Trials with Nonrandomized Real-world Evidence Studies: First Results from the RCT DUPLICATE Initiative,” Circulation, 143, 1002–1013. DOI: 10.1161/CIRCULATIONAHA.120.051718.
  • 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. (2021), “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment,” Statistics in Biopharmaceutical Research, DOI: 10.1080/19466315.2021.1883473.

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