Clinical trials in drug development: a minimalistic approach

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Abstract

Purpose of review Drug development in oncology finds itself at the crossroad of unique opportunities and major challenges. The old paradigms should and can be replaced by a system that better matches the right patients to the right compounds and puts much more emphasis on the early stages of drug development. Recent findings The clinical phases of drug development will no longer be split into phase I, II, and Ill studies, but rather into 'functional target pharmacology studies', followed by 'proof of concept studies'. The resulting development flow becomes Apollo-capsule shaped. Summary Although randomized studies will still be needed for drugs using targets in the tumor environment, or for combinations of agents, drug registration might proceed without these if all of the following criteria are met in early development: availability of preclinical convincing evidence that the drug's target is the functional driver behind the disease phenotype, availability of a predictive biomarker that enables appropriate and actual patient selection in early pharmacology studies, a Response
Original languageUndefined/Unknown
Pages (from-to)332-337
Number of pages6
JournalCurrent Opinion in Oncology
Volume24
Issue number3
DOIs
Publication statusPublished - 2012

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