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

Gilbert PB, Peng J, Han L, Lange T, Lu Y, Nie L, Shih MC, Waddy SP, Wiley K, Yann M, Zafari Z, Ghosh D, Follmann D, Juraska M, Díaz I.

Open source

DOI: 10.1093/biostatistics/kxaf018
Published: 2025-12-01
Container: Biostatistics
Publisher: Not recorded
Open access: yes

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Cite this work

BibTeX

@article{allodium:10.1093/biostatistics/kxaf018,
  title = {A surrogate endpoint-based provisional approval causal roadmap, illustrated by vaccine development.},
  author = {Gilbert PB and  Peng J and  Han L and  Lange T and  Lu Y and  Nie L and  Shih MC and  Waddy SP and  Wiley K and  Yann M and  Zafari Z and  Ghosh D and  Follmann D and  Juraska M and  Díaz I.},
  year = {2025},
  journal = {Biostatistics},
  doi = {10.1093/biostatistics/kxaf018},
  url = {https://doi.org/10.1093/biostatistics/kxaf018}
}

RIS

TY  - JOUR
TI  - A surrogate endpoint-based provisional approval causal roadmap, illustrated by vaccine development.
AU  - Gilbert PB
AU  -  Peng J
AU  -  Han L
AU  -  Lange T
AU  -  Lu Y
AU  -  Nie L
AU  -  Shih MC
AU  -  Waddy SP
AU  -  Wiley K
AU  -  Yann M
AU  -  Zafari Z
AU  -  Ghosh D
AU  -  Follmann D
AU  -  Juraska M
AU  -  Díaz I.
PY  - 2025
JO  - Biostatistics
DO  - 10.1093/biostatistics/kxaf018
UR  - https://doi.org/10.1093/biostatistics/kxaf018
ER  -

APA

PB, G., J, P., L, H., T, L., Y, L., L, N., MC, S., SP, W., K, W., M, Y., Z, Z., D, G., D, F., M, J., & I., D. (2025). A surrogate endpoint-based provisional approval causal roadmap, illustrated by vaccine development.. Biostatistics. https://doi.org/10.1093/biostatistics/kxaf018

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europe-pmc · retrieved 2026-09-26T11:10:45.288Z