TITE-CRM Resources

April 21, 2009

The Biostatistics Unit of the Comprehensive Cancer Center has developed a SAS tool to design and manage TITE-CRM trials. The program implements and extends the algorithm presented in Cheung & Chappell (Cheung YK, Chappell R. Sequential designs for phase I clinical trials with late-onset toxicities, Biometrics. 56:1177-1182, 2000), and has the following features:

  1. Estimation of probability toxicities, dose assignment and report generation based on current data for ongoing trials
  2. Simulation of TITE-CRM trials based on user-specified assumptions about recruitment and toxicity
  3. Allowance for escalation restrictions and variable hazard rates in estimation and dose allocation for both ongoing trials and simulations
  4. Consideration of variable recruitment in simulations
  5. Allowance for overshoot in dose assignment

The program is intended as an experimental platform, and does not have a GUI; the code must be modified to run the program for a given set of conditions. However, it is copiously commented, and a number of test data sets for verification and an extensive manual describing the options in the SAS program are available. While this program has been under development since 1999, and has been used to simulate and manage a number of TITE-CRM trials, there is of course no warranty implicit to either its suitability for any specific problem or the accuracy of its results. We encourage you to test the program using your data, and to report back to us if you find bugs or can suggest improvements.

Current Version

  • Tite-CRM Version 8.1 --- SAS tool to design and manage TITE-CRM trials with example sets, documentation, and validation report bundled as a .zip file

Archive Version