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Original Articles

Some Issues of Sample Size Calculation for Time-to-Event Endpoints Using the Freedman and Schoenfeld Formulas

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Pages 1285-1311 | Received 10 Mar 2014, Accepted 17 Oct 2014, Published online: 30 Jul 2015

REFERENCES

  • Abel, U., Jensen, K., Karapanagiotou-Schenkel, I. (2012). Sample sizes for time-to-event endpoints: Should you insure against chance variations in accrual? Contemporary Clinical Trials 33:456–458.
  • Allan, E. (1978). Breast cancer: The error of the exponential. European Journal of Cancer 14:1389–1393.
  • Barthel, F. M.-S., Babiker, A., Royston, P., Parmar, M. K. B. (2006). Evaluation of sample size and power for multi-arm survival trials allowing for non-uniform accrual, non-proportional hazards, loss to follow-up and cross-over. Statistics in Medicine 25:2521–2542.
  • Berkson, J., Gage, R. P. (1952). Survival curve for cancer patients following treatment. Journal of the American Statistical Association 47:501–515.
  • Bernstein, D., Lagakos, S. W. (1978). Sample size and power determination for stratified clinical trials. Journal of Statistical Computation and Simulation 8:65–73.
  • Cantor, A. B. (1991). Power estimation for rank tests using censored data: Conditional and unconditional. Controlled Clinical Trials 12:462–473.
  • Cantor, A. B. (1992). Sample size calculations for the log rank test: A Gompertz model approach. Journal of Clinical Epidemiology 45:1131–1136.
  • Case, L. D., Morgan, T. M. (2001). Duration of accrual and follow-up for two-stage clinical trials. Lifetime Data Analysis 7:21–37.
  • Collett, D. (2003). Modelling Survival Data in Medical Research (2nd ed.). London: Chapman & Hall.
  • Freedman, L. S. (1982). Tables of the number of patients required in clinical trials using the logrank test. Statistics in Medicine 1:121–129.
  • George, S. L., Desu, M. M. (1974). Planning the size and duration of a clinical trial studying the time to some critical event. Journal of Chronic Diseases 28:15–24.
  • Hade, E. M., Jarjoura, D., Wie, L. (2010). Sample size re-estimation in a breast cancer trial. Clinical Trials 7:219–226.
  • Halpern, J., Brown, Jr., B. (1987). Designing clinical trials with arbitrary specification of survival functions and for the log rank or generalized Wilcoxon test. Controlled Clinical Trials 8:177–189.
  • Halpern, J., Brown, Jr., B. (1993). A computer program for designing clinical trials with arbitrary survival curves and group sequential testing. Controlled Clinical Trials 14: 109–122.
  • Hayat, E. A., Suner, A., Uyar, Ö., Dursun, Ö., Orman, M. N. Kitapcioglu, G. (2010). Comparison of five survival models: Breast cancer registry data from Ege University Cancer Research Center. Turkiye Klinikleri Journal of Medical Sciences 30:1665–1674.
  • Heo, M., Faith, M. S., Allison, D. B. (1998). Power and sample size for survival analysis under the Weibull distribution when the whole life span is of interest. Mechanism of Ageing and Development 102:45–53.
  • Hoos, A., Eggermont, A. M. M., Janetzky, S., Hodi, F. S, Ibrahim, R., Anderson, A., Humphrey, R., Blumenstein, B., Old, L., Wolchok, J. (2010). Improved endpoints for cancer immunotherapy trials. Journal of the National Cancer Institute 102(18):1388–1397.
  • Hsieh, F. Y. (1992). Comparing sample size formulae for trials with unbalanced allocation using the logrank test. Statistics in Medicine 11:1091–1098.
  • Ingel, K., Jahn-Eimermacher, A. (2014). Sample-size calculation and reestimation for a semiparametric analysis of recurrent event data taking robust standard errors into account. Biometrical Journal (epublished ahead of print). DOI:10.1002/bimj.201300090.
  • Jahn-Eimermacher, A., Ingel, K. (2009). Adaptive trial design: A general methodology for censored time to event data. Contemporary Clinical Trials 30:171–177.
  • Jiang, Z., Wang, L., Li, C., Xia, J., Jia, H. (2012). A practical simulation method to calculate sample size of group sequential trials for time-to-event data under exponential and Weibull distribution. PLOS One 7(9):e44013. DOI:10.1371/journal.one.0044013.
  • Lakatos, E. (1988). Sample sizes based on the log-rank statistic in complex clinical trials. Biometrics 44:229–241.
  • Lakatos, E., Lan, K. K. G. (1992). A comparison of sample size methods for the logrank statistic. Statistics in Medicine 11:179–191.
  • Maller, R. A., Zhou, X. (1996). Survival Analysis with Long-Term Survivors. Chichester, UK: Wiley.
  • Moghimi-Dehkordi, B., Safaee, A., Pourhoseingholi, M. A., Fatemi, R., Tabeie, Z., Zali, M. R. (2008). Statistical comparison of survival models for analysis of cancer data. Asian Pacific Journal of Cancer Prevention 9:417–420.
  • Oellrich, S., Freischläger, F., Benner, A., Kieser, M. (1997). Sample size determination on survival time data—A review. Informatik, Biometrie und Epidemiologie in Medizin und Biologie 2:64–85.
  • Othus, M., Crowley, J. J., Barlogie, B. (2012). Cure-rate survival models in clinical trials. In Crowley, J., Hoering, A. (eds.); Handbook of Statistics in Clinical Oncology (3rd ed.) pp. 325–337. Boca Raton, FL: CRC Press.
  • Pasternack, B. S., Gilbert, H. S. (1971). Planning the duration of long-term survival time studies designed for accrual by cohorts. Journal of Chronic Diseases 24:681–700.
  • Peto, R., Peto, J. (1972). Asymptotically efficient rank invariant test procedures (with discussion). Journal of the Royal Statistical Society, Series A 135:185–206.
  • Rogon, C. (2009). Fallzahlplanung bei Daten mit Survivalendpunkt. Diploma Thesis. München: Department of Statistics, University of München.
  • Rubinstein, L. V., Gail, M. H., Santner, T. J. (1981). Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. Journal of Chronic Diseases 34:469–479.
  • Ryan, T. P. (2013). Sample Size Determination and Power. Hoboken, NJ: Wiley.
  • Schoenfeld, D. (1981). The asymptotic properties of nonparametric tests for comparing survival distributions. Biometrika 68:316–319.
  • Schoenfeld, D. A., Richter, J. R. (1982). Nomograms for calculating the number of patients needed for a clinical trial with survival as an endpoint. Biometrics 38:163–170.
  • Schoenfeld, D. A. (1983). Sample-size formula for the proportional-hazards regression model. Biometrics 39:499–503.
  • Shen, Y., Cai, J. (2003). Sample size reestimation for clinical trials with censored survival data. Journal of the American Statistical Association 98:418–426.
  • Sposto, R., Sather, H. N. (1985). Determining the duration of comparative clinical trials while allowing for cure. Journal of Chronic Diseases 38:683–690.
  • Wang, S. J., Kalpathy-Cramer, J., Kim, J. S., Fuller, C. D., Thomas C. R. (2010). Parametric survival models for predicting the benefit of adjuvant chemoradiotherapy in gallbladder cancer. AMIA Annual Symposium Proceedings 2010:847–851.
  • Wang, S., Zhang, J., Lu, W. (2012). Sample size calculation for the proportional hazards cure model. Statistics in Medicine 31:3959–3971.
  • Wassmer, G. (2006). Planning and analyzing adaptive group sequential survival trials. Biometrical Journal 48:714–729.
  • Xiong, C., Yan, Y., Ji, M. (2003). Sample sizes for comparing means of two lifetime distributions with type II censored data: Applications in an aging intervention study. Controlled Clinical Trials 24:283–293.

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