{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T17:42:24Z","timestamp":1792258944949,"version":"4.4.0"},"reference-count":9,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T00:00:00Z","timestamp":1791936000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Between 2021 and 2023, deidentified patient-level data and associated programming code from the biologics license application for Pfizer\u2019s covid-19 vaccine were published on the Internet. The release, which appears to be unprecedented in permitting public access to such granular data, allows new researchers to independently reproduce published analyses and extend published findings by conducting analyses that the original investigators did not report.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We downloaded 2370 files (26 gigabytes), including more than 30 SAS programming files, 2 data reviewer\u2019s guides, and 180 SAS Transport datasets from phmpt.org. We documented programming files and adapted them to run in our environment, aiming to reproduce four published tables and a figure reporting efficacy and safety results. We also sought to estimate vaccine efficacy against covid-19 hospitalization, a clinically meaningful and public health relevant measure of potential protection against serious disease that has not been reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>We were able to reproduce 334 of 352 data elements from four published efficacy and safety tables. Lacking original code, we could not reproduce one key efficacy analysis (a cumulative incidence curve). For our extended analyses, we judged that vaccine efficacy against covid-19 hospitalization could not be reliably calculated using the available datasets due to a paradoxical (and therefore unreliable) finding of more covid-19 hospitalizations (n\u2009=\u200943) than cases of severe covid-19 (n\u2009=\u200931).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>The public release of original datasets and patient-level data enabled the exact reproduction of most published efficacy and safety analyses, establishing a firm basis for further analyses. Our experience highlights the feasibility and enormous value of publicly releasing and analyzing patient-level clinical trial datasets.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17407745261491900","type":"journal-article","created":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T12:56:11Z","timestamp":1791982571000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Transparency of clinical trials: Reproducing and extending analyses"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7804-4113","authenticated-orcid":false,"given":"Peter","family":"Doshi","sequence":"first","affiliation":[{"name":"Department of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Jones","sequence":"additional","affiliation":[{"name":"Institute of Evidence-Based Healthcare, Bond University, Gold Coast, QLD, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaiser","family":"Fung","sequence":"additional","affiliation":[{"name":"Numbersense, Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Wastila","sequence":"additional","affiliation":[{"name":"Department of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,10,14]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"crossref","unstructured":"Institute of Medicine. Sharing clinical trial data: maximizing benefits minimizing risk. National Academies Press 2015 https:\/\/doi.org\/10.17226\/18998 (accessed 15 September 2025).","DOI":"10.17226\/18998"},{"key":"e_1_3_2_3_2","unstructured":"Vivli.org https:\/\/vivli.org\/ (accessed 25 April 2026)."},{"key":"e_1_3_2_4_2","unstructured":"ClinicalStudyDataRequest.com https:\/\/clinicalstudydatarequest.com\/ (accessed 25 April 2026)."},{"key":"e_1_3_2_5_2","unstructured":"Project Data Sphere https:\/\/www.projectdatasphere.org\/ (accessed 25 April 2026)."},{"key":"e_1_3_2_6_2","unstructured":"The YODA Project https:\/\/yoda.yale.edu\/ (accessed 25 April 2026)."},{"key":"e_1_3_2_7_2","unstructured":"Public Health and Medical Professionals for Transparency https:\/\/phmpt.org\/pfizer-16-plus-documents\/ (accessed 15 September 2025)."},{"key":"e_1_3_2_8_2","unstructured":"U.S. Food and Drug Administration. Pfizer-BioNTech Comirnaty COVID-19 vaccine related records. Biologics Electronic Reading Room (eFOIA). https:\/\/www.fda.gov\/about-fda\/center-biologics-evaluation-and-research-cber\/biologics-electronic-reading-room-efoia (accessed 18 June 2026)."},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2110345"},{"key":"e_1_3_2_10_2","unstructured":"Fung K Jones M. Annotated code for Pfizer vaccine efficacy and safety analyses. https:\/\/doi.org\/10.5281\/zenodo.17117994 (accessed 15 September 2025)."}],"container-title":["Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17407745261491900","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17407745261491900","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17407745261491900","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T16:53:13Z","timestamp":1792255993000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17407745261491900"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,14]]},"references-count":9,"alternative-id":["10.1177\/17407745261491900"],"URL":"https:\/\/doi.org\/10.1177\/17407745261491900","relation":{},"ISSN":["1740-7745","1740-7753"],"issn-type":[{"value":"1740-7745","type":"print"},{"value":"1740-7753","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,14]]},"article-number":"17407745261491900"}}