Maurie Markman, MD
Clinical trials in oncology serve several purposes. Phase I studies address dosing, toxicity, and increasingly preliminary evidence of therapeutic efficacy; phase II studies more critically demonstrate clinical utility and adverse effects; and phase III randomized studies more definitively compare 2 or more approaches in seeking an answer to a clinical question. These efforts ultimately help define and, potentially, modify the “standard of care” in routine cancer management. Finally, so-called phase IV studies are frequently employed by industry sponsors to obtain additional regulatory agency approvals or, alternatively, oncology drug compendium (eg, National Comprehensive Cancer Network) listing as acceptable strategies in particular clinical settings.
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