References
- Campbell, G. (2022), “Some Biostatistical Considerations about Real-World Data and Evidence in Clinical Studies, Especially for Regulatory Purposes,” Statistics in Biopharmaceutical Research,, this issue. DOI: 10.1080/19466315.2021.2000488.
- Chen, C., and Hsiao, C.-F. (2022), Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment”: “Is Real-World Evidence Real?,” Statistics in Biopharmaceutical Research. this issue. DOI: 10.1080/19466315.2021.1969267.
- Chen, J., Ho, M., Lee, K., Song, Y., Fang, Y., Goldstein, B., 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. (2022), “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.
- FDA (2021a), “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision- Making for Drug and Biological Products,” available at https://www.fda.gov/media/152503/download.
- FDA (2021b), “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products,” available at https://www.fda.gov/media/154449/download.
- FDA (2021c), “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products,” available at https://www.fda.gov/media/154714/download.
- 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.
- Hampson, L., Degtyarev, E., Tang, R., Lin, J., Rufibach, K., and Zheng, C. (2022), Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment,” Statistics in Biopharmaceutical Research, this issue. DOI: 10.1080/19466315.2021.1994459.
- Hernán, M. A., and Robins, J. M. (2016), “Using Big Data to Emulate a Target Trial when a Randomized Trial is not Available,” American Journal of Epidemiology, 183, 758–764. DOI: 10.1093/aje/kwv254.
- 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. (2022), “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., Ho, M., Lee, K., Mishra-Kalyani, P., Rockhold, F., Wang, H., and Zink, R. (2022), “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.
- Uemura, Y., Shinozaki, T., Nomura, S., and Shibata, T. (2022), Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment,” Statistics in Biopharmaceutical Research, this issue. DOI: 10.1080/19466315.2021.1974537.