Navigating US participant data sharing requirements: implications for international clinical trials
Rafael Dal-Ré and colleagues consider the challenges of new requirements to share individual participant data for US federally funded trials carried out in other countries
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Published in | BMJ Vol. 386; p. e079701 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
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England
British Medical Journal Publishing Group
06.09.2024
BMJ Publishing Group LTD BMJ Publishing Group |
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Abstract | Rafael Dal-Ré and colleagues consider the challenges of new requirements to share individual participant data for US federally funded trials carried out in other countries |
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AbstractList | Rafael Dal-Ré and colleagues consider the challenges of new requirements to share individual participant data for US federally funded trials carried out in other countries |
Author | Dal-Ré, Rafael Jha, Vivekanand Naudet, Florian Bekker, Linda-Gail Le Louarn, Anne |
Author_xml | – sequence: 1 givenname: Rafael surname: Dal-Ré fullname: Dal-Ré, Rafael email: rafael.dalre@quironsalud.es organization: Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain – sequence: 2 givenname: Linda-Gail surname: Bekker fullname: Bekker, Linda-Gail organization: Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, South Africa – sequence: 3 givenname: Vivekanand surname: Jha fullname: Jha, Vivekanand organization: School of Public Health, Imperial College, London, UK – sequence: 4 givenname: Anne surname: Le Louarn fullname: Le Louarn, Anne organization: GCS Comité National de Coordination de la Recherche (CNCR), Paris, France – sequence: 5 givenname: Florian surname: Naudet fullname: Naudet, Florian organization: University Institute of France, Paris, France |
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Cites_doi | 10.1093/jlb/lsad035 10.1186/s12916-022-02377-2 10.1038/s41591-022-02080-y 10.1136/bmj.j2372 10.1101/2023.11.14.566998 10.1136/bmjgh-2022-010157 10.17159/sajs.2023/15722 10.1056/EVIDoa2200293 10.1016/S0140-6736(23)02020-2 10.1016/j.lansea.2023.100318 10.17159/sajs.2023/15129 10.1038/d41586-019-01720-7 10.1136/bmj.q324 10.1016/j.jclinepi.2022.05.019 10.1001/jama.2018.10359 10.1056/NEJMoa2031994 10.1038/s41591-023-02292-w |
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go tohttp://group.bmj.com/group/rights-licensing/permissions2024BMJ Attribution - NonCommercial |
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SubjectTerms | Analysis Clinical trials Clinical Trials as Topic Consent COVID-19 FDA approval Funding General Data Protection Regulation Government agencies Humans Information Dissemination - methods Information sharing International Cooperation Life Sciences Personal information R&D Regulatory agencies Research & development Research ethics United States |
Title | Navigating US participant data sharing requirements: implications for international clinical trials |
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