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Journal of Biopharmaceutical Statistics Volume 33, 2023 - Issue 1
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Research Article

Two-stage designs with small sample sizes

Meinhard Kiesera Institute of Medical Biometry, Medical Center Ruprecht-Karls-University Heidelberg, Heidelberg, GermanyCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0003-2402-4333View further author information
ORCID Icon,
Geraldine Rauchb Charité – Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Biometry and Clinical Epidemiology, Berlin, GermanyORCID Iconhttps://orcid.org/0000-0002-2451-1660View further author information
ORCID Icon &
Maximilian Pilza Institute of Medical Biometry, Medical Center Ruprecht-Karls-University Heidelberg, Heidelberg, GermanyORCID Iconhttps://orcid.org/0000-0002-9685-1613View further author information
ORCID Icon
Pages 53-59 | Received 16 Nov 2021, Accepted 04 May 2022, Published online: 25 May 2022

References

  • Kunzmann, K., and M. Kieser. 2016. Optimal adaptive two-stage designs for single-arm trial with binary endpoint. arXiv. Accessed 24.05.2022. http://arxiv.org/abs/1605.00249.
  • Kunzmann, K., M. Pilz, C. Herrmann, G. Rauch, and M. Kieser. 2021. The adoptr package: adaptive optimal designs for clinical trials in R. Journal of Statistical Software 98 (9):1–21. doi:10.18637/jss.v098.i09.
  • Nikolakopoulos, S., K. C. B. Roes, and I. van der Tweel. 2016. Sequential designs with small samples: Evaluation and recommendations for normal responses. Statistical Methods in Medical Research 27 (4):1115–1127. doi:10.1177/0962280216653778.
  • O’Brien, P. C., and T. R. Fleming. 1979. A multiple testing procedure for clinical trials. Biometrics 35 (3):549–556. doi:10.2307/2530245.
  • Pilz, M., K. Kunzmann, C. Herrmann, G. Rauch, and M. Kieser. 2021. Optimal planning of adaptive two-stage designs. Statistics in Medicine 40 (13):3196–3213. doi:10.1002/sim.8953.
  • Pocock, S. J. 1977. Group sequential methods in the design and analysis of clinical trials. Biometrika 64 (2):191–199. doi:10.1093/biomet/64.2.191.
  • Rom, D. M., and J. A. McTague. 2020. Exact critical values for group sequential designs with small sample sizes. Journal of Biopharmaceutical Statistics 30 (4):752–764. doi:10.1080/10543406.2020.1730878.
  • Ryan, E. G., K. Brock, S. Gates, and D. Slade. 2020. Do we need to adjust for interim analyses in a Bayesian adaptive trial design? BMC Medical Research Methodology 20:150. doi:10.1186/s12874-020-01042-7.
  • Stallard, N., S. Todd, E. G. Ryan, and S. Gates. 2020. Comparison of Bayesian and frequentist group-sequential clinical trial designs. BMC Medical Research Methodology 20:4. doi:10.1186/s12874-019-0892-8.

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