- Predictive Biomarkers in Phase II/III Clinical Trials
- Biomarker Targeted Randomized Design
- Targeted design randomizes only marker positive patients to treatment or control arm. Untargeted design does not measure marker and randomizes all who otherwise are eligible.
- Biomarker Stratified Randomized Design
- Stratified design randomizes both marker positive and negative patients.
- Biomarker Targeted Randomized Design
- Optimal Two-Stage Designs for Phase II Clinical Trials
- Method from Richard Simon, Controlled Clinical Trials 10:1-10, 1989
- Integrated Phase II/III Study
- The integrated phase II/III study design contains two portions. In the first portion of the study evidence of activity is gathered using progression free survival (PFS). If there is sufficient evidence of activity, accrual continues, and enough patients are accrued until the phase III endpoint of overall survival can be assessed (patients from the first portion and the second portion are used in the final overall survival analysis) (Hunsberger, Zhao and Simon, Clin Cancer Res 2009).
- Sample Size Planning for Developing Classifiers
- Method from (Kevin Dobbin and Richard Simon, Biostatistics 8:101-17, 2007), (Kevin Dobbin, Yingdong Zhao and Richard Simon, Clinical Cancer Research 14:108-114, 2008).
- Design, Monitoring and Analysis of Bayesian Basket Discovery Trials
- Basket trials are early phase II cancer clinical trials of one drug in a population of patients with histologic types and/or genomic variants thought to make them responsive to the drug. Basket trials are discovery trials rather than hypothesis testing trials where the objective is to discover rather then test hypothesis on which histological type or genomic alterations sensitize the tumor to the drug. This application supports Sample size planning and Interim analysis for Basket trials.
- Bayesian Phase II Single Arm Clinical Trials - Binary Outcomes
- This application supports the conduct of simulations for a single arm phase II clinical trial of a new treatment T with a binary outcome variable.
- Bayesian Phase II Single Arm Clinical Trials - Time to Event Outcomes
- This application supports the conduct of simulations for a single arm phase II clinical trial of a new treatment T with time to event outcome variable.
