Tips for Accelerating BOIN Design

Author:

Kojima Masahiro,Wende Wu,Zhao Henry

Publisher

Springer Science and Business Media LLC

Reference10 articles.

1. Yuan Y, Lee JJ, Hilsenbeck SG. Model-assisted designs for early-phase clinical trials: simplicity meets superiority. JCO Precision Oncol. 2019;3:1–12.

2. Yuan Y, Hess KR, Hilsenbeck SG, Gilbert MR. Bayesian optimal interval design: a simple and well-performing design for phase I oncology trials. Clin Cancer Res. 2016;22(17):4291–301.

3. U.S. Food & Drug Administration. Drug Development Tools: Fit-for-Purpose Initiative. https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tools-fit-purpose-initiative

4. Ananthakrishnan R, Lin R, He C, Chen Y, Li D, LaValley M. An overview of the BOIN design and its current extensions for novel early-phase oncology trials. Contemp Clin Trials Commun. 2022;28:100943.

5. Pharmaceuticals and Medical Devices Agency. 「第7回 データサイエンスラウンドテーブル会議」の開催について. https://www.pmda.go.jp/review-services/symposia/0104.html

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