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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Phase II trials published in 2002: a cross-specialty comparison showing significant design differences between oncology trials and other medical specialties.

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 ...

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The critical decision in drug development is often at the end of phase II, as phase III trials are an expensive undertaking, with the potential for significant corporate and public consequences in the event of a negative phase III trial. Thus, retrospective analyses of the usefulness of phase II trials are welcomed and valued, as illustrated by the study of Goffin et al. (1). In this analysis o...

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The role of Phase II trials in oncology drug development Traditionally, Phase II in oncology drug development acts as a screening tool by identifying treatments with sufficient activity that warrant further investigation in large and costly Phase III studies. However, Phase II has also another more prominent role in cancer research as there is a significant number of drugs that were approved ba...

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ژورنال

عنوان ژورنال: Clinical Cancer Research

سال: 2007

ISSN: 1078-0432,1557-3265

DOI: 10.1158/1078-0432.ccr-06-1488