Table 3. Results of simulation study II – operating characteristics BCARA randomization design under various scenarios regarding the predictive or prognostic status of biomarkers.
Scenario | δ | Na | ProbA+b | Problc |
---|---|---|---|---|
Scenario 1: Not predictive or prognostic | 0.99 | 84 | 0.19 | 0.57 |
0.999 | 98 | 0.03 | 0.89 | |
Scenario 2: Prognostic | 0.99 | 77 | 0.27 | 0.42 |
0.999 | 96 | 0.08 | 0.85 | |
Scenario 3: Predictive | 0.99 | 65 | 0.74 | 0.11 |
0.999 | 85 | 0.39 | 0.43 | |
Scenario 4: Prognostic and predictive | 0.99 | 72 | 0.49 | 0.44 |
0.999 | 89 | 0.18 | 0.79 |
Mean total sample size across 500 replications profile randomized to treatment A.
Probability of declaring treatment A in subjects with positive biomarker status superior.
Probability of inconclusive result.