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Research Articles

Sample Size Calculation and Timing of Dose Selection in a Multiple-Dose Clinical Trial

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Pages 654-660 | Received 23 May 2021, Accepted 08 Aug 2022, Published online: 11 Oct 2022

References

  • Bauer, P. (1989), “Multistage Testing with Adaptive Designs,” Biometric und Informatik in Medizin und Biologie, 20, 130–148.
  • Bauer, P., and Köhne, K. (1994), “Evaluation of Experiments with Adaptive Interim Analyses,” Biometrics, 50, 1029–1041. (Correction in 1996, Biometrics, 52, 380). DOI: 10.2307/2533441.
  • Dunnett, C. W. (1984), “Selection of the Best Treatment in Comparison to a Control with Application to a Medical Trial,” In Design of Experiments: Ranking and Selection, eds T. J. Santner and A. C. Tamhane, New York: Marcel Dekker.
  • Posch, M., Koenig, F., Branson, M., Brannath, W., Dunger-Baldauf, C., and Bauer, P. (2005), “Testing and Estimation in Flexible Group Sequential Designs with Adaptive Treatment Selection,” Statistics in Medicine, 24, 3697–3714. DOI: 10.1002/sim.2389.
  • Proschan, M. A., and Hunsberger, S. A. (1995), “Designed Extension of Studies Based on Conditional Power,” Biometrics, 51, 1315–1324. DOI: 10.2307/2533262.
  • Ristl, R., Xi, D., Glimm, E., and Posch, M. (2018), “Optimal Exact Tests for Multiple Binary Endpoints,” Computational Statistics & Data Analysis, 122, 1–17.
  • Shen, L. (2001), “An Improved Method of Evaluating Drug Effect in a Multiple Dose Clinical Trial,” Statistics in Medicine, 20, 1913–1929. DOI: 10.1002/sim.842.
  • Thall, P. F., Simon, R., and Ellenberg, S. (1989), “A Two-Stage Design for Choosing Among Several Experimental Treatments and a Control in Clinical Trials,” Biometrics, 45, 537–547. DOI: 10.2307/2531495.
  • Whitehead, J. (1985), “Design Phase 2 Studies in the Context of a Programme of Clinical Research,” Biometrics, 41, 373–383. DOI: 10.2307/2530863.
  • Whitehead, J. (1986), “Sample Size for Phase 2 and Phase 3 Clinical Trials: An Integrated Approach,” Statistics in Medicine, 5, 459–464. DOI: 10.1002/sim.4780050510.

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