References
- Bell, J., Hamilton, A., Sailer, O., and Voss, F. (2021), “The Detailed Clinical Objectives Approach to Designing Clinical Trials and Choosing Estimands,” Pharmaceutical Statistics, 20, 1112–1124. DOI: 10.1002/pst.2129.
- Ionan, A. C., Paterniti, M., Mehrotra, D. V., Scott, J., Ratitch, B., Collins, S., Gomatam, S., Nie, L., Rufibach, K., and Bretz, F. (2022), “Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation,” Statistics in Biopharmaceutical Research, 1–6. DOI: 10.1080/19466315.2022.2081601.
- National Research Council. (2010), The Prevention and Treatment of Missing Data in Clinical Trials, Washington, DC: The National Academies Press. DOI: 10.17226/12955.
- Ratitch, B., Bell, J., Mallinckrodt, C., Bartlett, J. W., Goel, N., Molenberghs, G., O’Kelly, M., Singh, P., and Lipkovich, I. (2020), “Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice,” Therapeutic Innovation & Regulatory Science, 54, 324–341. DOI: 10.1007/s43441-019-00061-x.
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Center for Biologics Evaluation. (1998), “ICH Guidance for Industry: E9 Statistical Principles for Clinical Trials,” Available at www.fda.gov/media/71336/download
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Center for Biologics Evaluation. (2019), “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry,” Available at www.fda.gov/media/133660/download
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Center for Biologics Evaluation. (2021a), “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials Guidance for Industry,” Available at www.fda.gov/media/148473/download
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Center for Biologics Evaluation. (2021b), “Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment Guidance for Industry,” Available at www.fda.gov/media/154724/download