CTDSystems provides design and data analysis methods for two-stage phase II clinical trials

• A Brief manual for CTDSystems
• In Design Settings, Confidence Limit(%) is to specify the confidence limit for confidence intervals.
• In Confidence Interval, Lower Limit of UMVUE and Upper Limit of UMVUE are the limits of Jennison-Turnbull confidence intervals.
• The CI method based on MLE ordering is not published yet. MLE-CIs are obtained like UMVUE-CIs, but based on different orderings, MLE vs. UMVUE.
• Basic requirement for CTDSystems Applet: Java(TM) 2 Runtime Environment, Standard Edition 1.4.2 or 1.5
• For feedback, please register.
• Please send emails to sinho.jung@duke.edu for any questions and comments about CTDSystems.
• This program, CTDSystems, has gone through a thorough validation procedure. However, we can not guarantee that it is 100% error free yet. Please use our program at your own risk.


• For analysis of two-stage phase II trials, users may refer to
• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10: 1-10.
• Jung SH, Carey M and Kim KM. Graphical search for two-stage phase II clinical trials, Controlled Clinical Trials 2001; 22: 367-372.
• Jung SH, Lee TY, Kim KM, George S. Admissible two-stage designs for phase II cancer clinical trials, Stat Med 2004; 23: 561-569.
• ((For ‘Apply both boundaries’ option, refer to) - Chen TT. Optimal three-stage designs for phase II cancer clinical trials. Stat Med 1997; 16: 2701-2711.


• For analysis of two-stage phase II trials, users may refer to
  • Estimation of response rate:
  • Jung SH, Kim KM. On the estimation of the binomial probability in multistage clinical trials, Stat Med 2004; 23: 881-896.
  • Confidence interval of response rate:
  • Jennison C, Turnbull BW. Confidence intervals for a binomial parameter following a multistage test with application to MIL-STD 105D and medical trials. Technometrics 1983; 25:49-58.
  • Jung SH, Kim KM. On the estimation of the binomial probability in multistage clinical trials, Stat Med 2004; 23: 881-896.
  • P-value
  • Jung SH, Owzar K, George SL, Lee TY. P-value calculation for multistage phase II cancer clinical trials (with discussion), J Biopharmaceutical Statistics 2006; 16: 765-783.

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