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    When to include clinical study reports and regulatory documents in systematic reviews

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    Table 1 MIF paper 20-08-18.docx
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    Author
    Jefferson, T.
    Doshi, P.
    Boutron, I.
    Date
    2018
    Journal
    BMJ Evidence-Based Medicine
    Publisher
    BMJ Publishing Group
    Type
    Article
    
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    Show full item record
    See at
    https://dx.doi.org/10.1136/bmjebm-2018-110963
    Abstract
    Reporting bias is a major threat to the validity and credibility of systematic reviews. This article outlines the rationale for accessing clinical study reports and other regulatory documents (regulatory data) as a means of addressing reporting bias and identifies factors that may help decide whether (or not) to include regulatory data in systematic reviews. The article also describes the origins and current state of regulatory data access and summarises a survey of current systematic reviewers' practices in considering regulatory data for inclusion in systematic reviews. How to access and extract regulatory data is not addressed. Organisations and other stakeholders such as Cochrane should encourage the use of data from clinical study reports as an important source of data in reviews of pharmaceutical interventions particularly when the intervention in question is of high importance and the risk of reporting bias is great. Copyright Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved.
    Keyword
    clinical study reports
    regulatory documents
    reporting bias
    Review Literature as Topic
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85054922091&doi=10.1136%2fbmjebm-2018-110963&partnerID=40&md5=55927ff61b941ad2d70b74d90f62a21e; http://hdl.handle.net/10713/9449
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjebm-2018-110963
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