Phase II Trials Published in 2002: A Cross-Specialty Comparison Showing Significant Design Differences between Oncology Trials and Other Medical Specialties

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Abstract
Purpose: Phase II trials play an essential role in drug development pathway, and their conclusions often impact the decision to embark on large, pivotal trials. However, the determination of agent activity is highly dependent on trial design. Formal comparisons of phase II trial designs across medical specialties are uncommon. We hypothesized that there are significant differences in the design of trials conducted by oncologists and those conducted by other medical and surgical specialties.