• British medical bulletin · Jan 2015

    Review

    Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect.

    • Barbara Mintzes, Joel Lexchin, and Ancella Santos Quintano.
    • Charles Perkins Centre and Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia barbara.mintzes@sydney.edu.au.
    • Br. Med. Bull. 2015 Jan 1; 116: 43-53.

    BackgroundAlthough selective and incomplete publication is widely acknowledged to be a problem, full access to clinical trial data remains illusive.Sources Of DataAuthors' personal files, key documents from Food and Drug Administration and European Medicines Agency and focussed searches of PubMed.Areas Of AgreementExisting sources of information provide an incomplete overview of scientific research.Areas Of ControversyPersistent arguments about commercial confidentiality and the potential difficulties in de-identifying raw data can block important progress. Current industry efforts are voluntary and only partially satisfy the need for complete data.Growing PointsRequirements for trial registration are increasing. Important regulatory changes in particular in Europe have the potential to result in the release of more information.Areas Timely For Developing ResearchDocumenting the effects of prospective trial registration and requirements for proactive clinical trial publication on healthcare decisions, public health and rational resource allocation.© The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…