Shu‐Pang Huang

From Phase Ib/ II to Seamless Phase II / III : A Simulation‐Based Discussion of Design Strategies for Dose Optimization and Confirmatory Phase

The emergence of targeted therapies and immunotherapies has challenged the traditional "more is better" paradigm underlying maximum tolerated dose (MTD)-based trials, as dose escalation beyond receptor saturation often yields limited additional efficacy while substantially increa...