{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T03:50:07Z","timestamp":1784260207336,"version":"3.55.0"},"reference-count":54,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,6,22]],"date-time":"2025-06-22T00:00:00Z","timestamp":1750550400000},"content-version":"vor","delay-in-days":173,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R37AI054165"],"award-info":[{"award-number":["R37AI054165"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000738","name":"Department of Veterans Affairs","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000738","id-type":"DOI","asserted-by":"publisher"}]},{"name":"United States Government"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,31]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>For many rare diseases with no approved preventive interventions, promising interventions exist. However, it has proven difficult to conduct a pivotal phase 3 trial that could provide direct evidence demonstrating a beneficial effect of the intervention on the target disease outcome. When a promising putative surrogate endpoint(s) for the target outcome is available, surrogate-based provisional approval of an intervention may be pursued. Following the general Causal Roadmap rubric, we describe a surrogate endpoint-based provisional approval causal roadmap. Based on an observational study data set and a phase 3 randomized trial data set, this roadmap defines an approach to analyze the combined data set to draw a conservative inference about the treatment effect (TE) on the target outcome in the phase 3 study population. The observational study enrolls untreated individuals and collects baseline covariates, surrogate endpoints, and the target outcome, and is used to estimate the surrogate index\u2014the regression of the target outcome on the surrogate endpoints and baseline covariates. The phase 3 trial randomizes participants to treated vs. untreated and collects the same data but is much smaller and hence very underpowered to directly assess TE, such that inference on TE is based on the surrogate index. This inference is made conservative by specifying 2 bias functions: one that expresses an imperfection of the surrogate index as a surrogate endpoint in the phase 3 study, and the other that expresses imperfect transport of the surrogate index in the untreated from the observational to the phase 3 study. Plug-in and nonparametric efficient one-step estimators of TE, with inferential procedures, are developed. The finite-sample performance of the estimators is evaluated in simulation studies. The causal roadmap is motivated by and illustrated with contemporary Group B Streptococcus vaccine development.<\/jats:p>","DOI":"10.1093\/biostatistics\/kxaf018","type":"journal-article","created":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T07:39:39Z","timestamp":1748504379000},"source":"Crossref","is-referenced-by-count":3,"title":["A surrogate endpoint-based provisional approval causal roadmap, illustrated by vaccine development"],"prefix":"10.1093","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2662-9427","authenticated-orcid":false,"given":"Peter B","family":"Gilbert","sequence":"first","affiliation":[{"name":"Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Center, 1100 Fairview AVE N PO Box 19024, Seattle, WA 98109,","place":["United States"]},{"name":"Department of Biostatistics, University of Washington, 3980 15th Avenue NE, Box 351617, Seattle, WA 98195,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8245-8319","authenticated-orcid":false,"given":"James","family":"Peng","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, University of Washington, 3980 15th Avenue NE, Box 351617, Seattle, WA 98195,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0577-9661","authenticated-orcid":false,"given":"Larry","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Public Health and Health Sciences, Bouv\u00e9 College of Health Sciences, Northeastern University , 30 Leon St, MA 02115,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6807-8347","authenticated-orcid":false,"given":"Theis","family":"Lange","sequence":"additional","affiliation":[{"name":"Department of Public Health and Health, University of Copenhagen , Copenhagen K-1353,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9332-6832","authenticated-orcid":false,"given":"Yun","family":"Lu","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring , MD 20993,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7791-9395","authenticated-orcid":false,"given":"Lei","family":"Nie","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Avenue, Silver Spring , MD 20993,","place":["United 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20892,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-9232-0382","authenticated-orcid":false,"given":"Margot","family":"Yann","sequence":"additional","affiliation":[{"name":"School of Public Health, UC Berkeley, Forum for Collaborative Research, UCDC Campus, 1608 Rhode Island Avenue NW , Washington, DC 20036,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2507-4949","authenticated-orcid":false,"given":"Zafar","family":"Zafari","sequence":"additional","affiliation":[{"name":"School of Pharmacy, University of Maryland, 20 North Pine Street, Baltimore , MD 21201,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6618-1316","authenticated-orcid":false,"given":"Debashis","family":"Ghosh","sequence":"additional","affiliation":[{"name":"Department of Biostatistics & 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