Should the Choice of BOIN Design Parameter <em>p.tox</em> only Depend on the Target DLT Rate?

Abstract excerpt

IMPORTANCE: 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 of a new drug, assuming that dose-toxicity relationship is monotonically incre...

Topics

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• Carcinoma, Non-Small-Cell Lung
• Clinical Trials, Phase I as Topic
• Dose-Response Relationship, Drug
• Endpoint Determination
• ErbB Receptors
• Lung Neoplasms
• Mutation
• Quinazolinones

Identifiers and source

Literature Corpus work

fb70a26b-6f3d-5417-9ddf-c1511229007d

DOI

10.20944/preprints202403.0511.v1