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Original Articles

An Efficient Procedure for Calculating Sample Size Through Statistical Simulations

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Pages 1-8 | Received 01 Feb 2017, Published online: 26 Mar 2018

References

  • Bretz, F., Schmidli, H., Koenig, F., Racine, A., and Maurer, W. (2006), “Confirmatory Seamless Phase II/III Clinical Trials With Hypotheses Selection at Interim: General Concepts,” Biometrical Journal, 48, 623–634.
  • Burton, A., Altman, D. G., Royston, P., and Holder, R. L. (2006), “The Design of Simulation Studies in Medical Statistics,” Statistics in Medicine, 25, 4279–4292.
  • Chen, Y. H. J., DeMets, D. L., and Lan, K. K. G. (2004), “Increasing the Sample Size When the Unblinded Interim Result is Promising,” Statistics in Medicine, 23, 1023–1038.
  • Chow, S. C., and Chang, M. (2011), Adaptive Design Methods in Clinical Trials (2nd ed.), Boca Raton, FL: Chapman & Hall/CRC.
  • Cox, D. R. (1961), “Tests of Separate Families of Hypotheses,” in Proceedings of the 4th Berkeley Symposium 1, Berkeley, CA: University of California Press, pp. 105–112.
  • Cui, L., Hung, H. M. J., and Wang, S. J. (1999), “Modification of Sample Size in Group Sequential Clinical Trials,” Biometrics, 55, 853–857.
  • Demidenko, E. (2001), “Computational Aspects of Probit Model,” Mathematical Communications, 6, 233–247.
  • Julious, S. A. (2004), “Tutorial in Biostatistics: Sample Sizes for Clinical Trials With Normal Data,” Statistics in Medicine, 23, 1921–1986.
  • Julious, S. A., and Campbell, M. J. (2012), “Tutorial in Biostatistics: Sample Sizes for Parallel Group Clinical Trials With Binary Data,” Statistics in Medicine, 31, 2904–2936.
  • Maca, J., Bhattacharya, S., Dragalin, V., Gallo, P., and Krams, M. (2006), “Adaptive Seamless Phase II/III Designs-Background, Operational Aspects, and Examples,” Drug Information Journal, 40, 463–473.
  • Ratitch, B., O’Kelly, M., and Tosiello, R. (2013), “Missing Data in Clinical Trials: From Clinical Assumptions to Statistical Analysis Using Pattern Mixture Models,” Pharmaceutical Statistics, 12, 337–347.
  • Rubin, D. B. (1987), Multiple Imputation for Nonresponse in Surveys, New York: Wiley.
  • Schoenfeld, D. A. (1983), “Sample-Size Formula for the Proportional-Hazards Regression Model,” Biometrics, 39, 499–503.
  • Thall, P. F., Wathen, J. K., Champlin, B. N. B. R. E., Baker, L. H., and Benjamin, R. S. (2003), “Hierarchical Bayesian Approaches to Phase II Trials in Diseases With Multiple Subtypes,” Statistics in Medicine, 22, 763–780.
  • Tighiouart, M., Rogatko, A., and Babb, J. S. (2005), “Flexible Bayesian Methods for Cancer Phase I Clinical Trials: Dose Escalation With Overdose Control,” Statistics in Medicine, 24, 2183–2196.
  • Zhang, J., and Pulkstenis, E. (2016), “Sample Size and Power of Survival Trials in Group Sequential Design With Delayed Treatment Effect,” Statistics in Biopharmaceutical Research, 8, 268–275.
  • Zhu, H. (2017), “Sample Size Calculation for Comparing Two Poisson or negative Binomial Rates in Noninferiority or Equivalence Trials,” Statistics in Biopharmaceutical Research, 9, 107–115.

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