Biology-driven phase II trials: What is the optimal model for molecular selection?

In conclusion, molecular screening for phase II trials is becoming a major challenge in the field of oncology. The strengths and weaknesses of each testing modality are summarized in Table 1. From this analysis and their prior experience, the authors have identified some criteria that should be fulfilled by the molecular triage program. First, the test should be accurate and easy to implement. Second, the molecular characterization should assess several molecular alterations to provide asmany patients as possible with a targeted agent. Third, molecular screening should be independent of the screening phase of a phase II clinical trial testing a single treatment. Finally, the authors believe that the use of high-throughput technologies could prove advantageous by identifying rare molecular events and by avoiding the construction of specific bioassays at an early stage of drug development.