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. Author manuscript; available in PMC: 2016 Nov 15.
Published in final edited form as: Clin Trials. 2010 Jun 22;7(5):584–596. doi: 10.1177/1740774510373120

Table 3.

Operating characteristics for five designs in testing the marker effect, treatment effect, and marker by treatment interaction (marker predictive effect). The statistical power and overall response rate are shown in five scenarios.

Scenario Design Marker Effect Treatment Effect MK × Interaction** Overall Resp. Rate
In TX1* In TX2 Overall In MK(−) In MK(+) Overall In STR(−) In STR(+) STR(−) vs STR(+)
1 Simple Rand. 0.04 0.02 0.06 0.04 0.02 0.06 0.05 0.20
Marker Stratified 0.04 0.02 0.06 0.03 0.02 0.06 0.05 0.20
Marker Strategy 0.03 0.00 0.03 0.03 0.00 0.03 0.05 0.05 0.05 0.03 0.20
Efficient Target 0.04 0.20
Bayesian AR 0.03 0.02 0.05 0.02 0.04 0.06 0.03 0.20
2 Simple Rand. 0.46 0.45 0.71 0.04 0.02 0.06 0.05 0.30
Marker Stratified 0.47 0.47 0.72 0.03 0.03 0.06 0.05 0.30
Marker Strategy 0.40 0.28 0.56 0.03 0.02 0.04 0.06 0.46 0.05 0.04 0.30
Efficient Target 0.05 0.05 0.40
Bayesian AR 0.46 0.43 0.71 0.02 0.03 0.05 0.04 0.30
3 Simple Rand. 0.04 0.02 0.06 0.46 0.45 0.70 0.05 0.30
Marker Stratified 0.04 0.02 0.06 0.46 0.47 0.72 0.04 0.30
Marker Strategy 0.03 0.02 0.05 0.38 0.25 0.54 0.46 0.46 0.05 0.04 0.30
Efficient Target 0.47 0.30
Bayesian AR 0.02 0.03 0.05 0.36 0.38 0.62 0.02 0.34
4 Simple Rand. 0.04 0.95 0.95 0.04 0.95 0.95 0.64 0.30
Marker Stratified 0.04 0.95 0.95 0.03 0.94 0.95 0.62 0.30
Marker Strategy 0.03 0.86 0.86 0.03 0.84 0.84 0.46 0.95 0.25 0.46 0.35
Efficient Target 0.95 0.40
Bayesian AR 0.02 0.98 0.98 0.04 0.87 0.87 0.50 0.35
5 Simple Rand. 0.54 0.95 0.98 0.15 0.75 0.79 0.08 0.30
Marker Stratified 0.54 0.95 0.98 0.15 0.74 0.78 0.08 0.30
Marker Strategy 0.52 0.86 0.93 0.19 0.60 0.66 0.46 1.00 0.10 0.05 0.33
Efficient Target 0.75 0.45
Bayesian AR 0.40 0.98 0.99 0.19 0.66 0.71 0.06 0.34
*

: Testing whether marker is prognostic.

**

: Testing whether marker is predictive.

TX: Treatment; MK: Marker: STR: Strategy; Overall Resp. Rate: overall response rate.