Assessing Contribution of Treatment Phases through Tipping Point Analyses via Counterfactual Elicitation Using Rank Preserving Structural Failure Time Models

References

• Diéras, V., Han, H. S., Kaufman, B., Wildiers, H., Friedlander, M., Ayoub, J. P., Puhalla, S. L., Bondarenko, I., Campone, M., Jakobsen, E. H., Jalving, M., Oprean, C., Palácová, M., Park, Y. H., Shparyk, Y., Yañez, E., Khandelwal, N., Kundu, M. G., Dudley, M., Ratajczak, C. K., Maag, D., and Arun, B. K. (2020), “Veliparib with Carboplatin and Paclitaxel in BRCA-Mutated Advanced Breast Cancer (BROCADE3): A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial,” The Lancet. Oncology, 21, 1269–1282. DOI: 10.1016/S1470-2045(20)30447-2.
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation E9(R1) (2020), “Adden- dum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials,” EMA/CHMP/ICH/436221/2017.
   Google Scholar
• Latimer, N. R., Abrams, K. R., Lambert, P. C., Crowther, M. J., Wailoo, A. J., Morden, J. P., Akehurst, R. L., and Campbell, M. J. (2014), “Adjusting Survival Time Estimates to Account for Treatment Switching in Randomised Controlled Trials—An Economic Evaluation Context: Methods, Limitations, and Recommendations,” Medical Decision Making, 34, 387–402. DOI: 10.1177/0272989X13520192.
   PubMed Web of Science ®Google Scholar
• Latimer, N. R., Abrams, K. R., Lambert, P. C., Crowther, M. J., Wailoo, A. J., Morden, J. P., Akehurst, R. L., and Campbell, M. J. (2017), “Adjusting for Treatment Switching in Randomised Controlled Trials—A Simulation Study and a Simplified Two-Stage Method,” Statistical Methods in Medical Research, 26, 724–751. DOI: 10.1177/0962280214557578.
   PubMed Web of Science ®Google Scholar
• Latimer, N. R., Abrams, K. R., and Siebert, U. (2019), “Two-Stage Estimation to Adjust for Treatment Switching in Randomized Trials: A Simulation Study Investigating the Use of Inverse Probability Weighting Instead of Re-Censoring,” BMC Medical Research Methodology, 19, 1–19. DOI: 10.1186/s12874-019-0709-9.
   Google Scholar
• Permutt, T. (2016), “Sensitivity Analysis for Missing Data in Regulatory Submissions,” Statistics in Medicine, 35, 2876–2879. DOI: 10.1002/sim.6753.
   PubMed Web of Science ®Google Scholar
• Robins, J. M., and Tsiatis, A. A. (1991), “Correcting for Non-compliance in Randomised Trials Using Rank Preserving Structural Failure Time Models,” Communications in Statistics—Theory and Methods, 20, 2609–2631. DOI: 10.1080/03610929108830654.
   Web of Science ®Google Scholar
• Schmid, P., Cortes, J., Pusztai, L., McArthur, H., Kümmel, S., Bergh, J., Denkert, C., Park, Y. H., Hui, R., Harbeck, N., Takahashi, M., Foukakis, T., Fasching, P. A., Cardoso, F., Untch, M., Jia, L., Karantza, V., Zhao, J., Aktan, G., Dent, R., and O’Shaughnessy, J. (2020), “Pembrolizumab for Early Triple-Negative Breast Cancer,” New England Journal of Medicine, 382, 810–821. DOI: 10.1056/NEJMoa1910549.
   PubMed Web of Science ®Google Scholar
• Stupp, R., Mason, W. P., van den Bent, M. J., Weller, M., Fisher, B., Taphoorn, M. J. B., Belanger, K., Brandes, A. A., Marosi, C., Bogdahn, U., Curschmann, J., Janzer, R. C., Ludwin, S. K., Gorlia, T., Allgeier, A., Lacombe, D., Cairncross, J. G., Eisenhauer, E., and Mirimanoff, R. O. (2005), “Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma,” New England Journal of Medicine, 352, 987–996. DOI: 10.1056/NEJMoa043330.
   PubMed Web of Science ®Google Scholar
• White, I. R., Babiker, A. G., Walker, S., and Darbyshire, J. H. (1999), “Randomisation-Based Methods for Correcting for Treatment Changes: Examples from the Concorde Trial,” Statistics in Medicine, 18, 2617–2634. DOI: 10.1002/(SICI)1097-0258(19991015)18:19<2617::AID-SIM187>3.0.CO;2-E.
   PubMed Web of Science ®Google Scholar
• White, I. R., Walker, S., Babiker, A. G., and Darbyshire, J. H. (1997), “Impact of Treatment Changes on the Interpretation of the Concorde Trial,” Aids (London, England), 11, 999–1006.
   PubMed Web of Science ®Google Scholar
• Zhao, Y., Benjamin, R. S., Zhou, H., and Koch, G. G. (2016), “Sensitivity Analysis for Missing Outcomes in Time-to-Event Data with Covariate Adjustment,” Journal of Biopharmaceutical Statistics, 26, 269–279. DOI: 10.1080/10543406.2014.1000549.
   PubMed Web of Science ®Google Scholar