Type I Error Considerations in Master Protocols With Common Control in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion-Reference-Cited by-同舟云学术

Type I Error Considerations in Master Protocols With Common Control in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion

Published:2021-04-28 Issue: Volume: Page:1-4
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Sridhara Rajeshwari¹,Marchenko Olga²,Jiang Qi³,Pazdur Richard¹,Posch Martin⁴^ORCID,Redman Mary⁵,Tymofyeyev Yevgen⁶,Li Xiaoyun (Nicole)⁷,Theoret Marc¹,Shen Yuan Li¹,Gwise Thomas¹,Hess Lorenzo⁸,Coory Michael⁹,Raven Andrew¹⁰,Kotani Naoto¹¹,Roes Kit¹²,Josephson Filip¹²,Berry Scott¹³,Simon Richard¹⁴,Binkowitz Bruce¹⁵

Affiliation:

1. Oncology Center of Excellence US FDA

2. Bayer, Whippany, NJ

3. Seagen, Bothell, WA

4. Medical Statistics at the Medical University of Vienna, Vienna, Austria

5. Fred Hutch, Seattle, WA

6. Janssen, Titusville, NJ

7. Merck & Co., Inc., Kenilworth, NJ, USA

8. Swissmedic, Zurich, Switzerland

9. Department of Health, Perth, Australia

10. HC, Ottawa, Ontario, Canada

11. PMDA, Chiyoda-ku, Japan

12. Swedish Medical Products Agency (MPA), Uppsala, Sweden

13. Berry Consultants, TX, USA

14. Simon Consulting, Seattle, WA

15. Shionogi, Florham Park, NJ

Funder

EU-PEARL

European Union’s Horizon 2020 research and innovation programme and EFPIA

Children’s Tumor Foundation

Global Alliance for TB Drug Development non-profit organization

Springworks Therapeutics Inc

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2021.1906743

Reference12 articles.

1. Commentary on Parker and Weir

2. Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials

3. FDA Draft Guidance for Industry: Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics, October 2018. https://www.fda.gov/media/120721/download

4. Recommendations on multiple testing adjustment in multi-arm trials with a shared control group

5. The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review

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