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dc.contributor.authorDoshi, Peter
dc.contributor.authorJefferson, Tom
dc.contributor.authorDel Mar, Chris
dc.date.accessioned2017-06-15T13:36:47Z
dc.date.available2017-06-15T13:36:47Z
dc.date.issued2012-04-10
dc.identifier.citationDoshi, P., Jefferson, T., Del Mar, C. (2012). The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Medicine, 9(4):e1001201. DOI: 10.1371/journal.pmed.1001201en_US
dc.identifier.urihttp://hdl.handle.net/10713/6666
dc.description.abstractSummary points: - Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data. - More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators. - Unfortunately, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers. - We propose clinical study reports become available to such scrutiny, and describe one manufacturer's unconvincing reasons for refusing to provide us access to full clinical study reports. We challenge industry to either provide open access to clinical study reports or publically defend their current position of RCT data secrecy.en_US
dc.description.sponsorshipGrant support: 10/80/01/Department of Health/United Kingdom ; HTA/10/80/01/Department of Health/United Kingdom ; T32 HS019488/HS/AHRQ HHS/United States ; T32HS019488/HS/AHRQ HHS/United Statesen_US
dc.description.urihttp://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001201en_US
dc.language.isoen_USen_US
dc.publisherPublic Library of Scienceen_US
dc.subjectresearch transparencyen_US
dc.subjectaccess to documentsen_US
dc.subjectregulatory agenciesen_US
dc.subjectclinical study reportsen_US
dc.subject.meshAntiviral Agents--adverse effectsen_US
dc.subject.meshAntiviral Agents--therapeutic useen_US
dc.subject.meshDrug Industry--ethicsen_US
dc.subject.meshHumansen_US
dc.subject.meshInformation Disseminationen_US
dc.subject.meshOseltamivir--adverse effectsen_US
dc.subject.meshOseltamivir--therapeutic useen_US
dc.subject.meshOutcome Assessment (Health Care)en_US
dc.subject.meshRandomized Controlled Trials as Topicen_US
dc.subject.meshReview Literature as Topicen_US
dc.subject.meshClinical Trials as Topicen_US
dc.titleThe imperative to share clinical study reports: recommendations from the Tamiflu experienceen_US
dc.typeArticleen_US
dc.identifier.doi10.1371/journal.pmed.1001201
dc.identifier.pmid22505850
dc.identifier.ispublishedNoen_US
dc.description.urinameClick here for the free full-text article on publisher’s websiteen_US
refterms.dateFOA2019-02-19T18:19:27Z


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