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Statistics in Biopharmaceutical Research Volume 15, 2023 - Issue 1
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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”

Yukari Uemuraa Department of Data Science, Center for Clinical Research, National Center for Global Health and Medicine, Tokyo, JapanCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-3013-7775View further author information
ORCID Icon,
Tomohiro Shinozakib Department of Information and Computer Technology, Tokyo University of Science, Tokyo, JapanView further author information
,
Shogo Nomurac Department of Biostatistics and Bioinformatics, The University of Tokyo, Tokyo, JapanORCID Iconhttps://orcid.org/0000-0001-8734-6984View further author information
ORCID Icon &
Taro Shibatad Center for Research Administration and Support, Biostatistics Division, National Cancer Center, Tokyo, JapanView further author information
Pages 20-22 | Received 01 Aug 2021, Accepted 12 Aug 2021, Published online: 04 Oct 2021
 
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Acknowledgments

The authors thank to the research members of AMED Research on Regulatory Science of Pharmaceuticals and Medical Devices.

Additional information

Funding

This work was supported by the Japan Agency for Medical Research and Development (AMED) (grant number JP21mk0101154s0303).
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