Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion

Author:

Sridhara Rajeshwari1,Marchenko Olga2,Jiang Qi3,Pazdur Richard1,Posch Martin4ORCID,Berry Scott5,Theoret Marc1,Shen Yuan Li1,Gwise Thomas1,Hess Lorenzo6,Raven Andrew7,Rantell Khadija8,Roes Kit9,Simon Richard10,Redman Mary11,Ji Yuan12,Lu Cindy13

Affiliation:

1. Oncology Center of Excellence US FDA, Silver Spring, MD;;

2. Bayer, Whippany, NJ;

3. Seagen, Bothell, WA;;

4. Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria;;

5. Berry Consultants, Austin, TX;;

6. SMC, Bern, Switzerland;;

7. HC, Ottawa, ON, Canada;;

8. MHRA, London, UK;;

9. Radboud University Medical Center, Nijmegen, Netherlands;;

10. Simon Consulting, Seattle, WA;;

11. Fred Hutch, Seattle, WA;;

12. University of Chicago, Chicago, IL;;

13. Biogen, Cambridge, MA

Funder

Innovative Medicines Initiative

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

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