{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T23:48:31Z","timestamp":1775173711484,"version":"3.50.1"},"reference-count":37,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,9]],"date-time":"2023-03-09T00:00:00Z","timestamp":1678320000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Minist\u00e8re de l'Enseignement Sup\u00e9rieur, de la Recherche et de l'Innovation"}],"content-domain":{"domain":["www.ploscompbiol.org"],"crossmark-restriction":false},"short-container-title":["PLoS Comput Biol"],"abstract":"<jats:p>Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing:\n<jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>Rule 1: Abide by local legal and regulatory data protection requirements<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 2: Anticipate the possibility of clinical trial data-sharing before obtaining funding<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 3: Declare your intent to share data in the registration step<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 4: Involve research participants<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 5: Determine the method of data access<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 6: Remember there are several other elements to share<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 7: Do not proceed alone<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 8: Deploy optimal data management to ensure that the data shared is useful<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 9: Minimize risks<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Rule 10: Strive for excellence.<\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p>","DOI":"10.1371\/journal.pcbi.1010879","type":"journal-article","created":{"date-parts":[[2023,3,9]],"date-time":"2023-03-09T18:42:08Z","timestamp":1678387328000},"page":"e1010879","update-policy":"https:\/\/doi.org\/10.1371\/journal.pcbi.corrections_policy","source":"Crossref","is-referenced-by-count":14,"title":["Ten (not so) simple rules for clinical trial data-sharing"],"prefix":"10.1371","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8712-0766","authenticated-orcid":true,"given":"Claude","family":"Pellen","sequence":"first","affiliation":[]},{"given":"Anne","family":"Le Louarn","sequence":"additional","affiliation":[]},{"given":"Gilliosa","family":"Spurrier-Bernard","sequence":"additional","affiliation":[]},{"given":"Evelyne","family":"Decullier","sequence":"additional","affiliation":[]},{"given":"Jean-Marie","family":"Chr\u00e9tien","sequence":"additional","affiliation":[]},{"given":"Eric","family":"Rosenthal","sequence":"additional","affiliation":[]},{"given":"G\u00e9rard","family":"Le Goff","sequence":"additional","affiliation":[]},{"given":"David","family":"Moher","sequence":"additional","affiliation":[]},{"given":"John P. A.","family":"Ioannidis","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3760-3801","authenticated-orcid":true,"given":"Florian","family":"Naudet","sequence":"additional","affiliation":[]}],"member":"340","published-online":{"date-parts":[[2023,3,9]]},"reference":[{"key":"pcbi.1010879.ref001","article-title":"OSTP Issues Guidance to Make Federally Funded Research Freely Available Without Delay | OSTP","year":"2022","journal-title":"In: The White House"},{"key":"pcbi.1010879.ref002","doi-asserted-by":"crossref","first-page":"e1001950","DOI":"10.1371\/journal.pmed.1001950","article-title":"Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors","volume":"13","author":"DB Taichman","year":"2016","journal-title":"PLoS Med"},{"key":"pcbi.1010879.ref003","doi-asserted-by":"crossref","first-page":"e1003844","DOI":"10.1371\/journal.pmed.1003844","article-title":"Medical journal requirements for clinical trial data sharing: Ripe for improvement","volume":"18","author":"F Naudet","year":"2021","journal-title":"PLoS Med"},{"key":"pcbi.1010879.ref004","volume-title":"Sharing and reuse of health-related data for research purposes: WHO policy and implementation guidance","author":"World Health Organization","year":"2022"},{"key":"pcbi.1010879.ref005","article-title":"International Comparative Legal Guides. In: International Comparative Legal Guides International Business Reports","author":"GL Group","year":"2022","journal-title":"Global Legal Group"},{"key":"pcbi.1010879.ref006","doi-asserted-by":"crossref","first-page":"1201","DOI":"10.1001\/jama.2014.850","article-title":"Approaches and Costs for Sharing Clinical Research Data","volume":"311","author":"EE Wilhelm","year":"2014","journal-title":"JAMA"},{"key":"pcbi.1010879.ref007","doi-asserted-by":"crossref","first-page":"k400","DOI":"10.1136\/bmj.k400","article-title":"Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in The BMJ and PLOS Medicine","volume":"360","author":"F Naudet","year":"2018","journal-title":"BMJ"},{"key":"pcbi.1010879.ref008","doi-asserted-by":"crossref","first-page":"1990","DOI":"10.1056\/NEJMsb1708278","article-title":"Data Sharing from Clinical Trials\u2014A Research Funder\u2019s Perspective","volume":"377","author":"R Kiley","year":"2017","journal-title":"N Engl J Med"},{"key":"pcbi.1010879.ref009","year":"2022","journal-title":"NOT-OD-21-013: Final NIH Policy for Data Management and Sharing"},{"key":"pcbi.1010879.ref010","doi-asserted-by":"crossref","first-page":"e1004525","DOI":"10.1371\/journal.pcbi.1004525","article-title":"Ten Simple Rules for Creating a Good Data Management Plan","volume":"11","author":"WK Michener","year":"2015","journal-title":"PLoS Comput Biol"},{"key":"pcbi.1010879.ref011","volume-title":"Partage autour d\u2019un mod\u00e8le s\u2019appuyant sur une approche concert\u00e9e","author":"H Pernin","year":"2022"},{"key":"pcbi.1010879.ref012","doi-asserted-by":"crossref","first-page":"e0237464","DOI":"10.1371\/journal.pone.0237464","article-title":"Funders\u2019 data-sharing policies in therapeutic research: A survey of commercial and non-commercial funders","volume":"15","author":"JF Gaba","year":"2020","journal-title":"PLoS ONE"},{"key":"pcbi.1010879.ref013","article-title":"Tri-Agency Research Data Management Policy\u2014Science.gc.ca","author":"I. Government of Canada","year":"2022","journal-title":"Innovation, Science and Economic Development Canada;"},{"key":"pcbi.1010879.ref014","article-title":"Announcing the 2022\u20132023 Data Champions","year":"2022","journal-title":"In: Digital Research Alliance of Canada"},{"key":"pcbi.1010879.ref015","doi-asserted-by":"crossref","first-page":"1250","DOI":"10.1056\/NEJMe048225","article-title":"Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors","volume":"351","author":"C De Angelis","year":"2004","journal-title":"N Engl J Med"},{"key":"pcbi.1010879.ref016","doi-asserted-by":"crossref","first-page":"e2033972","DOI":"10.1001\/jamanetworkopen.2020.33972","article-title":"Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement","volume":"4","author":"V Danchev","year":"2021","journal-title":"JAMA Netw Open"},{"key":"pcbi.1010879.ref017","doi-asserted-by":"crossref","first-page":"2202","DOI":"10.1056\/NEJMsa1713258","article-title":"Clinical Trial Participants\u2019 Views of the Risks and Benefits of Data Sharing","volume":"378","author":"MM Mello","year":"2018","journal-title":"N Engl J Med"},{"key":"pcbi.1010879.ref018","year":"2022","journal-title":"Recommended Informed Consent Language for Data Sharing"},{"key":"pcbi.1010879.ref019","year":"2022","journal-title":"The YODA Project | Welcome to the YODA Project"},{"key":"pcbi.1010879.ref020","doi-asserted-by":"crossref","first-page":"144","DOI":"10.1038\/s41597-020-0486-7","article-title":"The TRUST Principles for digital repositories","volume":"7","author":"D Lin","year":"2020","journal-title":"Sci Data"},{"key":"pcbi.1010879.ref021","article-title":"What is DataSHIELD?","year":"2022","journal-title":"In: DataSHIELD"},{"key":"pcbi.1010879.ref022","doi-asserted-by":"crossref","first-page":"e1001946","DOI":"10.1371\/journal.pmed.1001946","article-title":"Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting System (TRS)","volume":"13","author":"DA Zarin","year":"2016","journal-title":"PLoS Med"},{"key":"pcbi.1010879.ref023","doi-asserted-by":"crossref","first-page":"e1003285","DOI":"10.1371\/journal.pcbi.1003285","article-title":"Ten Simple Rules for Reproducible Computational Research","volume":"9","author":"GK Sandve","year":"2013","journal-title":"PLoS Comput Biol"},{"key":"pcbi.1010879.ref024","doi-asserted-by":"crossref","first-page":"e3000737","DOI":"10.1371\/journal.pbio.3000737","article-title":"The Hong Kong Principles for assessing researchers: Fostering research integrity","volume":"18","author":"D Moher","year":"2020","journal-title":"PLoS Biol"},{"key":"pcbi.1010879.ref025","author":"R. Higman","year":"2016","journal-title":"Data Champions"},{"key":"pcbi.1010879.ref026","doi-asserted-by":"crossref","first-page":"160018","DOI":"10.1038\/sdata.2016.18","article-title":"The FAIR Guiding Principles for scientific data management and stewardship","volume":"3","author":"MD Wilkinson","year":"2016","journal-title":"Sci Data"},{"key":"pcbi.1010879.ref027","doi-asserted-by":"crossref","first-page":"e1008469","DOI":"10.1371\/journal.pcbi.1008469","article-title":"Ten quick tips for making things findable","volume":"16","author":"S Lin","year":"2020","journal-title":"PLoS Comput Biol"},{"key":"pcbi.1010879.ref028","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1038\/s41597-021-00892-0","article-title":"Operationalizing the CARE and FAIR Principles for Indigenous data futures","volume":"8","author":"SR Carroll","year":"2021","journal-title":"Sci Data"},{"key":"pcbi.1010879.ref029","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1016\/0895-4356(94)00098-B","article-title":"Selecting the language of the publications included in a meta-analysis: Is there a tower of babel bias?","volume":"48","author":"G Gr\u00e9goire","year":"1995","journal-title":"J Clin Epidemiol"},{"key":"pcbi.1010879.ref030","article-title":"Data Citation Synthesis Group","year":"2014","journal-title":"Joint Declaration of Data Citation Principles. Force11"},{"key":"pcbi.1010879.ref031","article-title":"Rights (OCR) O for C. Summary of the HIPAA Privacy Rule","year":"2008","journal-title":"In: HHS.gov"},{"key":"pcbi.1010879.ref032","article-title":"Article 29 Data Protection Working Party","journal-title":"Opinion 05\/2014 on Anonymisation Techniques"},{"key":"pcbi.1010879.ref033","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1038\/s41562-016-0021","article-title":"A manifesto for reproducible science","volume":"1","author":"MR Munaf\u00f2","year":"2017","journal-title":"Nat Hum Behav"},{"key":"pcbi.1010879.ref034","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s10654-021-00839-0","article-title":"Protecting against researcher bias in secondary data analysis: challenges and potential solutions","volume":"37","author":"JR Baldwin","year":"2022","journal-title":"Eur J Epidemiol"},{"key":"pcbi.1010879.ref035","year":"2022","journal-title":"Parasite awards"},{"key":"pcbi.1010879.ref036","year":"2022","journal-title":"Research Symbiont Awards"},{"key":"pcbi.1010879.ref037","year":"2022","journal-title":"Ouvrir la Science\u2014Clinical trial data sharing statement"}],"container-title":["PLOS Computational Biology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pcbi.1010879","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,9]],"date-time":"2023-03-09T18:42:27Z","timestamp":1678387347000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pcbi.1010879"}},"subtitle":[],"editor":[{"given":"Russell","family":"Schwartz","sequence":"first","affiliation":[]}],"short-title":[],"issued":{"date-parts":[[2023,3,9]]},"references-count":37,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,3,9]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pcbi.1010879","relation":{},"ISSN":["1553-7358"],"issn-type":[{"value":"1553-7358","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,9]]}}}