Two-/Three-Stage Designs for Phase 1&2 Clinical Trials

Calculate optimal Zhong's two-/three-stage Phase II designs (see Zhong (2012) ). Generate Target Toxicity decision table for Phase I dose-finding (two-/three-stage). This package also allows users to run dose-finding simulations based on customized decision table.

CRAN RStudio mirror downloads tsdf calculates optimal Zhong's two-/three-stage Phase II designs, generates two-/three-stage Phase 1 dose finding decision table and allows user to run dose-finding simulations using customized decision table.


To install from CRAN:


To install latest version from github :



[1] Bob Zhong, Single-arm phase IIA clinical trials with go/no-go decisions, 2012


tsdf 1.1-4

  • "dec.sim" now reports the probability of selected as over the MTD at each dose level
  • changed dose-finding simulation algorithm (more accurate MTD when the decision is "E")
  • changed parameters in Phase I dose-finding (pc --> pt)
  • Phase I designs now called Target Toxicity Design.
  • added option "pe.par" in dec.table function to calculate true type 2 error

tsdf 1.1-3

  • dec.table now supports HSD spending function
  • removed option pc.u in dec.table function
  • removed sf option in dec.table function
  • added sf.param option in dec.table function (more flexible)
  • updated vignettes

tsdf 1.1-2

  • added details and more examples
  • initial release on CRAN

tsdf 1.1-1

  • changed internal functions for calculating Phase 2 designs
  • changed the alpha-spending function used in Phase 2 designs
  • changed stopping criterion for Phase 2 designs
  • changed print method for class "" (more details)
  • fixed bugs when the threshold is an interval (Phase 2 design)
  • added complete feasible designs in the output of
  • added option : do not use alpha-spending method for two-stage designs so that the results is consistent with Zhong's paper
  • added option : maximum sample size for Phase 2 designs

tsdf 1.0-9

  • bug fixes
  • initial release on CRAN (fail)

tsdf 1.0-8

  • changed definition of MTD in "dec.sim"
  • "summary.dec.sim" is now more accurate
  • changed color scheme in "plot.dec.table"

tsdf 1.0-7

  • added Zhong's 2-/3-stage designs ( function)
  • added S3 method for
  • updated vignettes

tsdf 1.0-6

  • bug fixes
  • changed algorithm in internal functions
  • removed type 2 error in calculating decision table

tsdf 1.0-5

  • bug fixes
  • added two-stage designs

tsdf 1.0-4

  • fiexed bugs when target prob is less than the lowest toxicity probability
  • added prob. of no selection in the output of summary.dec.sim
  • changed color in plot.dec.table
  • "sl.sim" now doesn't need taget toxicity

tsdf 1.0-3

  • added a sample decision table in \inst\extdata
  • added vignettes
  • added more examples

tsdf 1.0-2

  • "dec.sim" now can run simulation for any customized decision table
  • added format checking in "dec.sim"
  • added an example scenarios list "testS.csv"
  • added few examples in a couple of functions
  • added detail warning messages in "dec.table" function

tsdf 1.0-1

  • "dec.sim" function returns average number of dlts and proportions of MTD at each dose level
  • changed "n.patients" in "dec.sim" object to average number of patients at each dose level
  • added simulation informations in "summary" method of "dec.sim" object
  • added warnings in "summary" method of "dec.sim" object
  • added type="dlt" in "plot" method of "dec.sim" object

tsdf 1.0-0

  • added "dec.sim", "sl.sim" functions
  • added S3 method "summary" and "plot" for class "dec.sim"

tsdf 0.1.0

  • initial release on github

Reference manual

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1.1-8 by Wenchuan Guo, a year ago

Browse source code at

Authors: Wenchuan Guo , Jianan Hui , Bob Zhong

Documentation:   PDF Manual  

GPL-2 license

Suggests knitr

See at CRAN