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Bypassing phase 2 in cancer drug development erodes the risk/benefit balance in phase 3 trials.

Hannah Moyer,Merlin Bittlinger,Angela Nelson, Luciano Fernandez,Jacky Sheng,Yuetong Wang,Joseph C Del Paggio,Jonathan Kimmelman

Journal of clinical epidemiology（2023）

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Abstract
The risk/benefit balance of P3 trials that bypass P2 is less favourable than for trials supported by P2.
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Key words
Clinical Trials,Drug Development,Ethics,Oncology,Phase 2,Phase 3
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