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Valentine Barboux

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Dual‐Criterion Approach Incorporating Historical Information to Seek Accelerated Approval With Application in Time‐to‐Event Group Sequential Trials

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By Marco Ratta, Gaëlle Saint-Hilary, Mauro Gasparini, Valentine Barboux
| Wiley Online Library Verified
1 Introduction Developing a new drug—from early phases to commercialization—is an extensive journey that requires substantial economic resources and time. This lengthy process is essential for rigorously evaluating many clinical aspects to guarantee the safety and efficacy of experimental treatments. However, accelerating drug developments becomes imperative for drugs filling unmet medical needs, where saving time may seriously impact the population survival [1].
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