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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

Author

Marie Ferron

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Review Sep 2026

Are safety lead-in phase II clinical trials really safe?

Background/AimsPhase II trials with a safety lead-in (SLI), allowing one or two dose de-escalations based on toxicities from the first several patients at a dose, are increasingly common in oncology. Despite increased demand, formal evaluation of SLI designs remains limited to dose selection without evaluating the perf...

Emily N. Potts, Marie Ferron, L. Biard et al. · 0 citations

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