References
- Brannath, W., Koenig, F., & Bauer, P. (2007). Multiplicity and flexibility in clinical trials. Pharmaceutical Statistics, 6(3), 205–216. https://doi.org/10.1002/pst.302
- Demets, D. L., & Lan, K. K. G. (1994). Interim analysis: The alpha spending function approach. Statistics in Medicine, 13(13–14), 1341–1352. https://doi.org/10.1002/(ISSN)1097-0258
- Englert, S., & Kieser, M. (2012). Improving the flexibility and efficiency of phase II designs for oncology trials. Biometrics, 68(3), 886–892. https://doi.org/10.1111/j.1541-0420.2011.01720.x
- Englert, S., & Kieser, M. (2015). Methods for proper handling of overrunning and underrunning in phase II designs for oncology trials. Statistics in Medicine, 34(13), 2128–2137. https://doi.org/10.1002/sim.v34.13
- Guo, W., Hui, J., & Zhong, B. (2019). TSDF: Two-/three-stage designs for phase 1&2 clinical trials. R package version 1.1-7.
- Hong, S., & Wang, Y. (2007). A three-outcome design for randomized comparative phase ii clinical trials. Statistics in Medicine, 26(19), 3525–3534. https://doi.org/10.1002/(ISSN)1097-0258
- Hwang, I. K., Shih, W. J., & De Cani, J. S. (1990). Group sequential designs using a family of type i error probability spending functions. Statistics in Medicine, 9(12), 1439–1445. https://doi.org/10.1002/(ISSN)1097-0258
- Jennison, C., & Turnbull, B. W. (2000). Group sequential methods with applications to clinical trials, Chapman and Hall.
- Koyama, T., & Chen, H. (2008). Proper inference from Simon's two-stage designs. Statistics in Medicine, 27(16), 3145–3154. https://doi.org/10.1002/sim.v27:16
- Li, G., Shih, W. J., Xie, T., & Lu, J. (2002). A sample size adjustment procedure for clinical trials based on conditional power. Biostatistics, 3(2), 277–287. https://doi.org/10.1093/biostatistics/3.2.277
- O'Brien, P. C., & Fleming, T. R. (1979). A multiple testing procedure for clinical trials. Biometrics, 35(3), 549–556. https://doi.org/10.2307/2530245
- Proschan, M. A., & Hunsberger, S. A. (1995). Designed extension of studies based on conditional power. Biometrics, 51(4), 1315–1324. https://doi.org/10.2307/2533262
- Sargent, D. J., Chan, V., & Goldberg, R. M. (2001). A three-outcome design for phase ii clinical trials. Controlled Clinical Trials, 22(2), 117–125. https://doi.org/10.1016/S0197-2456(00)00115-X
- Shan, G., & Chen, J. J. (2018). Optimal inference for Simon's two-stage design with over or under enrollment at the second stage. Communications in Statistics -- Simulation and Computation, 47(4), 1157–1167. https://doi.org/10.1080/03610918.2017.1307398
- Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials, 10(1), 1–10. https://doi.org/10.1016/0197-2456(89)90015-9
- Whitehead, J. (1992). Overrunning and underrunning in sequential clinical trials. Controlled Clinical Trials, 13(2), 106–121. https://doi.org/10.1016/0197-2456(92)90017-T
- Zhong, B. (2012). Single-arm phase IIa clinical trials with go/no-go decisions. Contemporary Clinical Trials, 33(6), 1272–1279. https://doi.org/10.1016/j.cct.2012.07.006
- Zhong, W., & Zhong, B. (2013). One-sample proportion testing procedure for hypothesis of inequality. Journal of Biopharmaceutical Statistics, 23(3), 604–617. https://doi.org/10.1080/10543406.2012.756501