References
- Akacha, M., Branson, J., Bretz, F., Dharan, B., Gallo, P., Gathmann, I., Hemmings, R., Jones, J., Xi, D., and Zuber, E. (2020), “Challenges in Assessing the Impact of the Covid-19 Pandemic on the Integrity and Interpretability of Clinical Trials,” Statistics in Biopharmaceutical Research, 12, 419–426. DOI: 10.1080/19466315.2020.1788984.
- Han, P., and Wang, L. (2013), “Estimation with Missing Data: Beyond Double Robustness,” Biometrika, 100, 417–430. DOI: 10.1093/biomet/ass087.
- ICH (2019), “International Council for Hamonisation Topic E9(R1) on Estimands and Sensitivity Analysis in Clinical Trials.” Available at www.ich.org.
- Lasch, F., and Guizzaro, L. (2022), “Estimators for Handling COVID-19-Related Intercurrent Events with a Hypothetical Strategy,” Pharmaceutical Statistics, 21, 1258–1280. DOI: 10.1002/pst.2244.
- Meyer, R. D., Ratitch, B., Wolbers, M., Marchenko, O., Quan, H., Li, D., Fletcher, C., Li, X., Wright, D., Shentu, Y., Englert, S., Shen, W., Dey, J., Liu, T., Zhou, M., Bohidar, N., Zhao, P.-L., and Hale, M. (2020), “Statistical Issues and Recommendations for Clinical Trials Conducted during the Covid-19 Pandemic,” Statistics in Biopharmaceutical Research, 12, 399–411. DOI: 10.1080/19466315.2020.1779122.
- Olarte Parra, C., Daniel, R. M., and Bartlett, J. W. (2022), “Hypothetical Estimands in Clinical Trials: A Unifcation of Causal Inference and Missing Data Methods,” Statistics in Biopharmaceutical Research, 1–12. DOI: 10.1080/19466315.2022.2081599.
- Van Lancker, K., Tarima, S., Bartlett, J., Bauer, M., Bharani-Dharan, B., Bretz, F., Flournoy, N., Michiels, H., Olarte Parra, C., Rosenberger, J. L., and Cro, S. (2022), “Estimands and Their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic,” Statistics in Biopharmaceutical Research, 1–12. DOI: 10.1080/19466315.2022.2094459.