Advantages

• Smart, novel and ethical approach
• Permits updating patient's outcome.
• Can result in high probability of success of the trial as there is increase in the number of patients who receive effective treatments.
• Type I and II errors can be controlled by carefully calibrating the design parameters
• Can boost patients' ethics as patients are assigned to the best available therapy.

Limitations

• Complexity in terms of building-up the trial design, conduct and analysis of the trial
• Can make incorrect decisions in case of incorrect biomarker selection as the design is based on the accumulated data about how well the biomarker performs.
• Requirement of relatively short biomarker and endpoint assessment
• Likely to introduce bias due to time trends in the prognostic mix of individuals enrolled to the study.