Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment

Author:

Levenson Mark1,He Weili2,Chen Jie3,Fang Yixin2,Faries Douglas4,Goldstein Benjamin A.56,Ho Martin7,Lee Kwan8,Mishra-Kalyani Pallavi1,Rockhold Frank56ORCID,Wang Hongwei2,Zink Richard C.9

Affiliation:

1. CDER, FDA, Silver Spring, MD;;

2. Global Medical Affairs Statistics, Data and Statistical Sciences, AbbVie, North Chicago, IL;;

3. Overland Pharmaceuticals, Dover, DE;;

4. Global Statistical Sciences, Eli Lilly & Company, Indianapolis, IN;;

5. Department of Biostatistics & Bioinformatics, Duke University, Durham, NC;;

6. Duke Clinical Research Institute, Duke University, Durham, NC;;

7. CBER, FDA, Silver Spring, MD;;

8. Statistics and Decision Sciences, Janssen Research and Development (retired), Spring House, PA;;

9. Lexitas Pharma Services, Inc., Durham, NC

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

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