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Leveraging real-world evidence for determining performance goals for medical device studies.
Wang, Chenguang; Rosner, Gary L; Bao, Tingting; Lu, Nelson; Chen, Wei-Chen; Li, Heng; Tiwari, Ram; Xu, Yunling; Yue, Lilly Q.
Affiliation
  • Wang C; Oncology Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.
  • Rosner GL; Oncology Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.
  • Bao T; Data Science Institute, Fu Foundation School of Engineering and Applied Science, Columbia University, New York, New York, USA.
  • Lu N; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Chen WC; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li H; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Tiwari R; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Xu Y; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yue LQ; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Stat Med ; 40(29): 6577-6589, 2021 12 20.
Article in En | MEDLINE | ID: mdl-34561895
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Goals Limits: Humans Language: En Journal: Stat Med Year: 2021 Document type: Article Affiliation country: Country of publication:
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Goals Limits: Humans Language: En Journal: Stat Med Year: 2021 Document type: Article Affiliation country: Country of publication: