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Statistics in Biopharmaceutical Research Volume 15, 2023 - Issue 3
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Research Articles

Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development

Mark Levensona FDA CDER, Silver Spring, MD; Correspondence[email protected]
,
Weili Heb Global Medical Affairs Statistics, Data and Statistical Sciences, AbbVie, North Chicago, IL;
,
Li Chenb Global Medical Affairs Statistics, Data and Statistical Sciences, AbbVie, North Chicago, IL;
,
Sai Dharmarajana FDA CDER, Silver Spring, MD;
,
Rima Izemc Novartis Institutes for BioMedical Research Basel, Basel-Stadt, CH, Switzerland;
,
Zhaoling Mengd Sanofi, Cambridge, MA;
,
Herbert Pange Genentech/Roche, South San Francisco, CA;
&
Frank Rockholdf Department of Biostatistics & Bioinformatics, Duke University, Durham, NC; ;g Duke Clinical Research Institute, Duke University, Durham, NCORCID Iconhttps://orcid.org/0000-0003-3732-4765
ORCID Icon show all
Pages 689-696 | Received 05 Feb 2022, Accepted 24 Aug 2022, Published online: 07 Oct 2022

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