This computer program provides a basis for constructing, simulating, and conducting
the EffTox phase I-II clinical trial design described in the paper “Dose-finding
based on efficacy-toxicity trade-offs”, Thall and Cook, Biometrics
60:684-693,2004 . Please read this paper before using
this program, which implements the trial design, simulation, and conduct. Please
note that as of version 4.0.0 very important improvements/refinements have been made in two key elements,
(1) the prior and (2) the trade-off contour. These are explained in the tutorial,
available here and
in the computer program.
What's New in Version 5.0.0
- Improved user interface, bug fixes, and a simplified code base
- Checks for updates to the program, automatically and on demand
- Targets the Microsoft .NET Framework 4.6.1
What was New in Versions 4.0.0 through 4.0.12
- Very important improvements/refinements have been made in two key elements:
- the prior, especially regarding effective sample size (ESS), and
- the trade-off contour
- Toxicity probability model constrained not to decrease with dose
- Context-specific help and guidance on achieving a good design
- Simulation scenarios now allow dependent outcome probabilities, if desired
- Simulation output is now HTML
- Much easier to use, especially trial conduct
- Minor bug fixes and other improvements in stability, performance, and error reporting
- Occasionally sends usage statistics and crash reports to our biostatistics software
support team to improve your experience using the software
- Windows 7
(other Windows versions may be compatible but this has not been tested)
- Administrative permissions may be required to install EffTox depending on the chosen
- The following packages will be installed if they or compatible replacements are not present:
- Microsoft .NET Framework 4.6.1
- Microsoft Visual C++ 2013 Runtime Libraries (x86)
- Microsoft Windows Installer 4.5
- To view the trade-off
function details a PDF file viewer (not included with the software) such as
Adobe Reader (available for free here)
must be installed.
- To follow the "Send feedback via email" link in the Help -> About EffTox...
window, an email client such as Microsoft Outlook (not included with the software)
must be installed.
Clift Norris developed the original user interface using
C#, C++, and the Microsoft .NET framework version 1.1. Richard
Herrick, Clift Norris, Juan Posadas, and John Venier developed the current user interface using
C#, C++, and the Microsoft .NET framework version 4.6.1.
John Cook implemented the original
simulation kernel using Visual C++. Richard Herrick, Clift Norris, and John
Venier modified it.
Peter F. Thall and John D. Cook. Dose-Finding Based on Efficacy-Toxicity
Trade-Offs. Biometrics 60, pp.
684-693, September 2004.
 Peter F. Thall and John D. Cook. Adaptive dose-finding based
on efficacy-toxicity trade-offs Encyclopedia of Biopharmaceutical Statistics,
2nd Edition. Chein-Chung Chow editor. 2006
 Peter F. Thall, John D. Cook, and
Eli Estey. Adaptive dose selection using efficacy-toxicity trade-offs: illustrations
and practical considerations.
Journal of Biopharmaceutical Statistics Vol 16, No. 5, pp. 623-638,