Cancer chemotherapy and pharmacology
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Cancer Chemother. Pharmacol. · Nov 2014
Predicting success in regulatory approval from Phase I results.
Drug development in oncology is resource intensive and has a high failure rate. In this exploratory analysis, we aimed to identify the characteristics and outcomes of published Phase I studies associated with future Food and Drug Administration (FDA) approval. ⋯ These preliminary findings indicate that objective responses in Phase I trials may have predictive value for later regulatory approval.