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A surrogate endpoint-based provisional approval causal roadmap, illustrated by vaccine development.

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第一作者: Peter B,Gilbert
第一单位: Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Center, 1100 Fairview AVE N PO Box 19024, Seattle, WA 98109, United States.;Department of Biostatistics, University of Washington, 3980 15th Avenue NE, Box 351617, Seattle, WA 98195, United States.
作者: Peter B,Gilbert [1] ; James,Peng [2] ; Larry,Han [3] ; Theis,Lange [4] ; Yun,Lu [5] ; Lei,Nie [6] ; Mei-Chiung,Shih [7] ; Salina P,Waddy [8] ; Ken,Wiley [8] ; Margot,Yann [9] ; Zafar,Zafari [10] ; Debashis,Ghosh [11] ; Dean,Follmann [12] ; Michal,Juraska [13] ; Iván,Díaz [14]
作者单位: Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Center, 1100 Fairview AVE N PO Box 19024, Seattle, WA 98109, United States.;Department of Biostatistics, University of Washington, 3980 15th Avenue NE, Box 351617, Seattle, WA 98195, United States. [1] Department of Biostatistics, University of Washington, 3980 15th Avenue NE, Box 351617, Seattle, WA 98195, United States. [2] Department of Public Health and Health Sciences, Bouvé College of Health Sciences, Northeastern University, 30 Leon St, MA 02115, United States. [3] Department of Public Health and Health, University of Copenhagen, Copenhagen K-1353, Denmark. [4] Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States. [5] Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Avenue, Silver Spring, MD 20993, United States. [6] VA Palo Alto Health Care System, Food and Drug Administration, 3801 Miranda Ave, Palo Alto, CA 94025, United States. [7] Division of Clinical Innovation, National Center for Advancing Translational Sciences, National Institutes of Health, 31 Center Drive MSC 2128 Bethesda, MD 20892, United States. [8] School of Public Health, UC Berkeley, Forum for Collaborative Research, UCDC Campus, 1608 Rhode Island Avenue NW, Washington, DC 20036, United States. [9] School of Pharmacy, University of Maryland, 20 North Pine Street, Baltimore, MD 21201, United States. [10] Department of Biostatistics & Informatics, Colorado School of Public Health, 13001 E. 17th Place, Aurora, CO 80045, United States. [11] Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852, United States. [12] Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, 1100 Fairview AVE N, PO Box 19024, Seattle, WA 98109, United States. [13] Department of Biostatistics, New York University Grossman School of Medicine, 180 Madison Ave New York, NY, MD 10016, United States. [14]
DOI 10.1093/biostatistics/kxaf018
PMID 40544344
发布时间 2026-03-09
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Biostatistics (Oxford, England)

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