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In oncology research, phase II clinical trials always have been a critical step along the drug-development pathway for new antineoplastic agents. Phase II trials are designed to assess drug activity and safety in a specific disease subset and typically involve 20 to 80 patients. As we have moved into an era of unprecedented drug development, the number of agents in development has increased rapidly. With new drug approvals becoming increasingly expensive and problematic, the “go-or-no-go decision” on a novel agent often hinges on data from phase II investigations. These investigators hypothesized that measurable differences exist between phase II trials conducted in oncology, compared with those conducted in other medical specialties, and t…