Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study-Reference-Cited by-同舟云学术

Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study

Published:2016-07-02 Issue:3 Volume:8 Page:248-257
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Chen Cong¹,Li Xiaoyun (Nicole)¹,Yuan Shuai¹,Antonijevic Zoran²,Kalamegham Rasika³,Beckman Robert A.⁴

Affiliation:

1. Biostatistics and Research Decision Sciences, Merck Research Laboratories, Upper Gwynedd, PA, USA

2. Development Design Center, Amgen Inc., Thousand Oaks, CA, USA

3. American Association for Cancer Research, Office of Science Policy and Government Affairs, Washington, DC, USA

4. Departments of Oncology and of Biostatistics, Bioinformatics, and Biomathematics, Lombardi Comprehensive Cancer Center and Innovation Center for Biomedical Informatics, Georgetown University Medical Center, Washington, DC, USA

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2016.1193044

Reference29 articles.

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

2. Selection and bias-Two hostile brothers

3. Beckman, R. A., Antonijevic, Z., Kalamegham, R, and Chen, C. (in press), “Design for a Basket Trial in Multiple Tumor Types Based on a Putative Predictive Biomarker,” Clinical Pharmacology & Theraputics, forthcoming.

4. Integrating predictive biomarkers and classifiers into oncology clinical development programmes

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