An example of planning, conducting, and decision making in an oncology dose-finding trial with expansion cohorts
Author:
Affiliation:
1. Data Science, Astellas Pharma Inc.
2. Data Science, Astellas Pharma Global Development, Inc.
3. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine
4. Business Development, Astellas Pharma Inc.
Publisher
The Biometric Society of Japan
Subject
General Medicine
Link
https://www.jstage.jst.go.jp/article/jjb/42/2/42_65/_pdf
Reference24 articles.
1. [1]Barlow RE, Bartholomew DJ, Bremner JM and Brunk HD. Statistical Inference Under Order Restrictions. London：Wiley；1972.
2. [2]Cheung Y, Chappell R. Sequential Designs for Phase I Clinical Trials with Late-Onset Toxicities. Biometrics. 2000；56：1177-1182. Iasonos A, O’Quigley J. Sequential monitoring of Phase I dose expansion cohorts. Stat Med. 2017；36(2)：204-214.
3. [3]Ivanova, A. Escalation, group and A＋B designs for dose-finding trials. Stat Med. 2006；25：3668-3678.
4. [4]Ji Y, Liu P, Li Y, Bekele BN. A modified toxicity probability interval method for dose-finding trials. Clinl Trials. 2010；7(6)：653-663.
5. [5]Jin IH, Liu S, Thall PF, Yuan Y. Using Data Augmentation to Facilitate Conduct of Phase I-II Clinical Trials with Delayed Outcomes. J Am Stat Assoc. 2014；109(506)：525-536.
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