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    The imperative to share clinical study reports: recommendations from the Tamiflu experience

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    Author
    Doshi, Peter
    Jefferson, Tom
    Del Mar, Chris
    Date
    2012-04-10
    Publisher
    Public Library of Science
    Type
    Article
    
    Metadata
    Show full item record
    See at
    http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001201
    Abstract
    Summary 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.
    Citation
    Doshi, 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.1001201
    Sponsors
    Grant 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 States
    Keyword
    research transparency
    access to documents
    regulatory agencies
    clinical study reports
    Antiviral Agents--adverse effects
    Antiviral Agents--therapeutic use
    Drug Industry--ethics
    Humans
    Information Dissemination
    Oseltamivir--adverse effects
    Oseltamivir--therapeutic use
    Outcome Assessment (Health Care)
    Randomized Controlled Trials as Topic
    Review Literature as Topic
    Clinical Trials as Topic
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    Identifier to cite or link to this item
    http://hdl.handle.net/10713/6666
    ae974a485f413a2113503eed53cd6c53
    10.1371/journal.pmed.1001201
    Scopus Count
    Collections
    Dr. Peter Doshi

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