{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T05:30:01Z","timestamp":1790832601891,"version":"4.1.0"},"reference-count":37,"publisher":"BMJ","license":[{"start":{"date-parts":[[2019,7,10]],"date-time":"2019-07-10T00:00:00Z","timestamp":1562716800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.bmj.com\/company\/legal-information\/terms-conditions\/legal-information\/tdm-licencepolicy"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To develop and pilot a tool to measure and improve pharmaceutical companies\u2019 clinical trial data sharing policies and practices.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Cross sectional descriptive analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015.<\/jats:p><\/jats:sec><jats:sec><jats:title>Data sources<\/jats:title><jats:p>Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve company data sharing policies and practices.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Only 25% of large pharmaceutical companies fully met the data sharing measure. The median company data sharing score was 63% (interquartile range 58-85%). Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33% and the median company data sharing score to 80% (73-100%). The most common reasons companies did not initially satisfy the data sharing measure were failure to share data by the specified deadline (75%) and failure to report the number and outcome of their data requests. Across new drug applications, a median of 100% (interquartile range 91-100%) of trials in patients were registered, 65% (36-96%) reported results, 45% (30-84%) were published, and 95% (69-100%) were publicly available in some form by six months after FDA drug approval. When examining results on the drug level, less than half (42%) of reviewed drugs had results for all their new drug applications trials in patients publicly available in some form by six months after FDA approval.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>It was feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Among large companies, 25% made participant level trial data accessible to external investigators for new drug approvals in accordance with the current study\u2019s measures; this proportion improved to 33% after applying the ranking tool. Other measures of trial transparency were higher. Some companies, however, have substantial room for improvement on transparency and data sharing of clinical trials.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmj.l4217","type":"journal-article","created":{"date-parts":[[2019,7,10]],"date-time":"2019-07-10T15:15:10Z","timestamp":1562771710000},"page":"l4217","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":53,"title":["Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices"],"prefix":"10.1136","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3591-369X","authenticated-orcid":false,"given":"Jennifer","family":"Miller","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph S","family":"Ross","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Wilenzick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle M","family":"Mello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,7,10]]},"reference":[{"key":"key20190711000508_ref1","article-title":"42 CFR Part 11: Clinical Trials Registration and Results Information Submission; Action: Final Rule","volume":"81","author":"Department of Health and Human Services","year":"2016","journal-title":"Fed Regist"},{"key":"key20190711000508_ref2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa1713258"},{"key":"key20190711000508_ref3","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.2841"},{"key":"key20190711000508_ref4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1605348"},{"key":"key20190711000508_ref5","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j3334"},{"key":"key20190711000508_ref6","doi-asserted-by":"publisher","DOI":"10.17226\/18998"},{"key":"key20190711000508_ref7","unstructured":"Reaffirming and Broadening Our Commitment to Transparency and Clinical Trial Data Sharing. 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