Considerations for master protocols using external controls-Reference-Cited by-同舟云学术

Considerations for master protocols using external controls

Published:2024-02-16 Issue: Volume: Page:1-23
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Chen Jie¹,Li Xiaoyun (Nicole)²,Lu Chengxing (Cindy)³,Yuan Sammy⁴,Yung Godwin⁵,Ye Jingjing⁶,Tian Hong⁷,Lin Jianchang⁸

Affiliation:

1. Data Sciences, ECR Global, Shanghai, China

2. Global Statistics, BeiGene, San Mateo, California, USA

3. Oncology Biometrics, AstraZeneca, Boston, Massachusetts, USA

4. Oncology Statistics, GlaxoSmithKline, Collegeville, Pennsylvania, USA

5. Product Development Data and Statistical Sciences, Genentech/Roche, South San Francisco, Cambridge, USA

6. Global Statistics and Data Sciences, BeiGene, Fulton, Maryland, USA

7. Global Statistics, BeiGene, Ridgefield Park, New Jersy, USA

8. Statistical & Quantitative Sciences, Takeda, Cambridge, Massachusetts, USA

Funder

no funding

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2024.2311248

Reference90 articles.

1. Using Synthetic Controls: Feasibility, Data Requirements, and Methodological Aspects

2. Synthetic Control Methods for Comparative Case Studies: Estimating the Effect of California’s Tobacco Control Program

3. Anes A. A. Arana K. Blake J. Bonhoeffer S. Evans and A. Fourrier-Réglat 2021. Guide on methodological standards in pharmacoepidemiology (revision 9 2021). European medicines agency. The European network of centres for pharmacoepidemiology and pharmacovigilance (ENCePP). Date of access: September 22 2021.

4. Advances in Electronic Phenotyping: From Rule-Based Definitions to Machine Learning Models

5. Adaptive Design for a Confirmatory Basket Trial in Multiple Tumor Types Based on a Putative Predictive Biomarker