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Statistics in Biopharmaceutical Research Volume 15, 2023 - Issue 1
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Special Section: A Collection of Articles on Opportunities and Challenges in Utilizing Real-World Data for Clinical Trials and Medical Product Development

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

Mark Levensona CDER, FDA, Silver Spring, MD;; Correspondence[email protected]
,
Weili Heb Global Medical Affairs Statistics, Data and Statistical Sciences, AbbVie, North Chicago, IL;;
,
Jie Chenc Overland Pharmaceuticals, Dover, DE;;
,
Yixin Fangb Global Medical Affairs Statistics, Data and Statistical Sciences, AbbVie, North Chicago, IL;;
,
Douglas Fariesd Global Statistical Sciences, Eli Lilly & Company, Indianapolis, IN;;
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Benjamin A. Goldsteine Department of Biostatistics & Bioinformatics, Duke University, Durham, NC;; ;f Duke Clinical Research Institute, Duke University, Durham, NC;;
,
Martin Hog CBER, FDA, Silver Spring, MD;;
,
Kwan Leeh Statistics and Decision Sciences, Janssen Research and Development (retired), Spring House, PA;;
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Pallavi Mishra-Kalyania CDER, FDA, Silver Spring, MD;;
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Frank Rockholde Department of Biostatistics & Bioinformatics, Duke University, Durham, NC;; ;f Duke Clinical Research Institute, Duke University, Durham, NC;; ORCID Iconhttps://orcid.org/0000-0003-3732-4765
ORCID Icon,
Hongwei Wangb Global Medical Affairs Statistics, Data and Statistical Sciences, AbbVie, North Chicago, IL;;
&
Richard C. Zinki Lexitas Pharma Services, Inc., Durham, NC
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Pages 3-13 | Received 01 May 2020, Accepted 26 Jan 2021, Published online: 10 Mar 2021

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