Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial-Reference-Cited by-同舟云学术

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Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial

Published:2018-02-08 Issue:5 Volume:28 Page:870-883
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Takahashi Fumihiro¹²,Morita Satoshi³

Affiliation:

1. Department of Biostatistics, Graduate School of Medicine, Yokohama City University, Japan

2. Biostatistics, Data Science Department, Ikuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Japan

3. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Shogoin, Japan

Funder

Ministry of Health, Labour and Welfare of Japan

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2018.1428614

Reference34 articles.

1. Antonijevic, Z., Bolognese, J., Burman, C. F., Chuang-Stein, C., Jennison, C., Kimber, M., Marchenko, O., Patel, N., Pinheiro, J. (2013). A progress report from the DIA adaptive program work stream. Biopharmaceutical Report 20:3–9.

2. Where's the utility in Bayesian data-monitoring of clinical trials?

3. I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

4. A Bayesian dose-finding trial with adaptive dose expansion to flexibly assess efficacy and safety of an investigational drug

5. A Review and Assessment of Potential Sources of Ethnic Differences in Drug Responsiveness

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