REFERENCES
- Chang, W. H., Chuang-Stein, C. (2004). Type I error and power in trials with one interim futility analysis. Pharmaceutical Statistics 3:51–59.
- DeMets, D. L. (2006). Futility approaches to interim monitoring by data monitoring committees. Clinical Trials 3:522–529.
- Dobbins, T. W. (2013). The type II error probability of a group sequential test of efficacy and futility, and considerations for power and sample size. Journal of Biopharmaceutical Statistics 23:378–393.
- Ellenberg, S. S., Fleming, T. R., DeMets, D. L. (2002). Data Monitoring Committees in Clinical Trials. Chichester, UK: Wiley.
- Emerson, S. E., Kittelson, J. M., Gillen, D. L. (2005). On the use of stochastic curtailment in group sequential clinical trials. University of Washington Biostatistics Working Paper Series #243: http://www.emersonstatistics.com/dnlds/bep243.pdf
- Emerson, S. S., Kittelson, J. M., Gillen, D. L. (2007). Frequentist evaluation of group sequential clinical trial designs. Statistics in Medicine 26:5047–5080.
- Evans, S. R., Li, L., Wei, L. J. (2007). Data monitoring in clinical trials using prediction. Drug Information Journal 41:733–742.
- Friedlin, B., Korn, E. L., Gray, R. (2010). A general inefficacy interim monitoring rule for randomized clinical trials. Clinical Trials 7:197–208.
- Jennison, C., Turnbull, B. W. (2000). Group Sequential Methods With Applications to Clinical Trials. London, UK: Chapman & Hall/CRC.
- Lachin, J. M. (2005). A review of methods for futility stopping based on conditional power. Statistics in Medicine 24:2747–2764.
- Lachin, J. M. (2009). Futility interim monitoring with control of type I and type II error probabilities using the interim Z-value or confidence limit. Clinical Trials 6:565–573.
- Lan, K. K. G., Simon, R., Halperin, M. (1982). Stochastically curtailed tests in long-term clinical trials. Sequential Analysis 1:207–219.
- Lan, K. K. G., DeMets, D. L. (1983). Discrete sequential boundaries for clinical trials. Biometrika 70:659–663.
- Lan, K. K. G., Wittes, J. (1988). The B-value: A tool for monitoring clinical trials. Biometrics 44:579–585.
- Ohrn, C. F. (2011). Group sequential and adaptive methods—Topics with applications to clinical trials. PhD dissertation, University of Bath, Bath, UK.
- Pampallona, S., Tsiatis, A. A., Kim, K. (2001). Interim monitoring of group sequential trials using spending functions for the type I and type II error probabilities. Drug Information Journal 35:1113–1121.
- Snapinn, S., Chen, M. G., Jiang, Q., Koutsoukos, T. (2006). Assessment of futility in clinical trials. Pharmaceutical Statistics 5:273–281.
- Spiegelhalter, D. J., Freedman, L. S., Blackburn, P. R. (1986). Monitoring clinical trials: conditional or predictive power? Controlled Clinical Trials 7:8–17.
- Zhang, Y., Clarke, W. R. (2010). A flexible futility monitoring method with time-varying conditional power boundary. Clinical Trials 7:209–218.