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  • Feature ArticlesFeature Articles

    FDA’s Oncology Clinical Trial Makeover

    Recent communication by FDA affirming its support for modernized oncology clinical trial conduct, manifested in four guidance documents addressing adolescents, conduct of First-in-Human (FIH) expansion cohorts, the use of placebo/maintenance of the study blind and master protocols. This article provides an overview of new FDA guidances related to oncology drug development and a review of pilot programs aiding faster access to new, innovative treatments without increasing r...