Are phase 0 clinical trials really necessary?
This question was posed by James Doroshow (National Cancer Institute, Bethesda, USA) at the 20th EORT-NCI-AARC Symposium on Molecular Targets and Cancer Therapeutics (Geneva, 21–24 October 2008). Together with E Leo (Beerse, Belgium), James Doroshow-since 2004 Director of the Division of Cancer Treatment and Diagnosis at NCI-was co-chairing the workshop on phase 0 clinical trials. In his introduction to the speakers, Doroshow raised six open questions, namely whether phase 0 trials are useful, ethically acceptable, feasible, whether they speed up the drug development process and save money, and whether there is room for improvement.
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