Elsevier

The Lancet

Volume 369, Issue 9577, 9–15 June 2007, Pages 1909-1911
The Lancet

Comment
Clinical trial registration: looking back and moving ahead

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References (5)

  • Clinical trial registration: a statement from the International Committee of Medical Journal Editors

  • RJ Simes

    Publication bias: the case for an international registry of clinical trials

    J Clin Oncol

    (1986)
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    This should increase clinical trial transparency, keeping in mind that 5.0% of 1,110 trials on DDIs in this study were funded by the NIH. There are other positive changes in this respect, such as the ICMJE update of their 2005 trial data reporting recommendations [27] to provide opportunities for researchers to point out safety concerns and guide future research from phase 1 clinical trials [39]. Regarding the reporting of AEs, the WHO encourages to report them as health outcome(s) [40].

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    In 2004, the International Committee of Medical Journal Editors (ICMJE) recommended that all clinical trials should be registered and stated “All ICMJE member journals will require, as a condition of consideration for publication, registration in a public trials registry” [2]. An increase in the number of registered trials followed, but it was by no means comprehensive and unregistered trials continue to be published [3–8]. Trial registration information can be found in various regional and international trial registries such as clinicaltrials.gov, operated by the US National Institutes of Health and the collated trial registry portal provided by the World Health Organization, the International Clinical Trials Registry Portal. [9–11].

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    Since 1997, the HTA programme has published the minutes of funding meetings. Protocols of almost all funded studies are also published,11,12 helping analyses of selective reporting of results.13 Patient and public involvement has always been a requirement for projects for the HTA programme.

  • Clinical trial registration: Implications for stakeholders

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