2023
DOI: 10.1002/pst.2306
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A comparative study of adaptive trial designs for dose optimization

Abstract: Recently, the US Food and Drug Administration Oncology Center of Excellence initiated Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development. The agency pointed out that the current paradigm for dose selection—based on the maximum tolerated dose (MTD)—is not sufficient for molecularly targeted therapies and immunotherapies, for which efficacy may not increase after the dose reaches a certain level. In these cases, it is more appropriate to identify the optimal … Show more

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