Web Application for simulating operating characteristics of the CDP method for single-agents

Division of Translational Research & Applied Statistics, University of Virginia; nwages@virginia.edu

1. Enter an assumed set of true DLT probabilities, separated by commas. Note: The length of this set should be equal to the number of possible study dose levels.

2. Enter the target DLT probability that defines the MTD for the study.

3. Enter the cohort size required before the next model-based update. Cohort size may be 1, 2, or 3 patients.

4. Enter the maximum sample size for the study. This number should be a multiple of the cohort size entered above.

5. Enter the total number of patients treated on any dose required to stop the trial. At any point in the trial, if the recommendation is to assign the next cohort to a dose that already has the entered number of patients treated on the dose, the study is stopped and the recommended dose is declared the MTD. If the entered number is larger than the maximum sample size, each trial will accrue to the maximum sample size.

6. Enter the number of simulations. A minimum of 1000 is recommended.

7. Set the seed of the random number generator.

8. Specify the threshold for defining the safety stopping rule based on an unacceptable high DLT rate at the lowest study dose level.

        

          

            This application simulates operating characteristics for the CDP method [1] with each simulated trial beginning at the lowest study dose level.
          

          References:
          

            [1] Conaway MR, Dunbar S, Peddada S (2004). Designs for single- and multiple-agent phase I trials, 
            Biometrics;
            60
            : 661-669.
          

        

        
      

      

        
Web Application for implementation of the CDP method

        

          Division of Translational Research & Applied Statistics, University of Virginia;
          nwages@virginia.edu
        

        

        

          Design / Protocol Information
        

        
1. Enter the target DLT rate probability that defines the MTD for the study.

        

          
          
        

        

        

          Observed Trial Data (do not count 'replaced' patients)
        

        

          2. Enter number of observed DLTs at each dose level. If none have been observed or a dose level has not yet been tried, enter '0'.
          Note:
          The length of this set should be equal to the number of possible study dose levels.
        

        

          
          
        

        

        

          3. Enter the number of patients evaluated for DLT at each dose level. If a dose level has not yet been tried, enter '0'.
          Note:
          The length of this set should be equal to the number of possible study dose levels.
        

        

          
          
        

        

        
4. Enter the most recent dose level administered in the study.

        

          
          
        

        

        
5. Specify the threshold for defining the safety stopping rule based on an unacceptable high DLT rate at the lowest study dose level.

        

          
          
        

        

          
        

        

        

          

            This application computes a recommended dose level for the next patient in a phase I trial according to the CDP method [1] for a trial beginning at the lowest study dose level.
          

          References:
          

            [1] Conaway MR, Dunbar S, Peddada S (2004). Designs for single- and multiple-agent phase I trials, 
            Biometrics;
            60
            : 661-669.
          

        

        
      

      

        
Web Application for generating safety stopping bounds at the lowest study dose level computed from the posterior distribution of the DLT rate at the lowest dose level based on a beta prior distribution.

        

          Division of Translational Research & Applied Statistics, University of Virginia;
          nwages@virginia.edu
        

        

        
1. Specify the threshold for defining the safety stopping rule based on an unacceptable high DLT rate at the lowest study dose level.

        

          
          
        

        
2. Enter the target DLT rate probability that defines the MTD for the study.

        

          
          
        

        
3. Enter the maximum sample size for the study.

        

          
          
        

        

          
        

        

        

          

            This application computes the safety stopping bounds for the lowest study dose level computed from the posterior distribution of the DLT rate at the lowest dose level based on a beta prior distribution.