Should the choice of BOIN design parameter<i>p.tox</i>only depend on the target DLT rate?

Abstract excerpt

<h4>ABSTRACT</h4> <h4>IMPORTANCE</h4> On December 10, 2021, the FDA published a Determination Letter, along with a Statistical Review and Evaluation Report, and concluded that under the non-informative prior, the local Bayesian optimal interval design (BOIN) design, in its revised form, can be designated fit-for-purpose for identifying the maximum tolerated dose (MTD) of a new drug, assuming that dose-toxicity rel...

Topics

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• Clinical Trials, Phase I as Topic
• Dose-Response Relationship, Drug
• Endpoint Determination
• Maximum Tolerated Dose
• Molecular Targeted Therapy
• Patient Selection
• Research Design
• Transcriptome

Identifiers and source

Literature Corpus work

cc24807b-bf61-5290-8989-472497d33420

DOI

10.1101/2024.03.06.24303862