Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012
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  • Published on:
    Response to Miller et al on clinical trial transparency

    The article by Miller et al. published on 12th November (1) took a similar approach to previous studies by Rawal and Deane (2, 3) that also set out to examine the clinical trial evidence related to recently approved medicines. The article therefore requires some qualification; while the study examines some of the industry-sponsored clinical trials related to 15 selected new medicines approved by the FDA in 2012, their st...

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    Conflict of Interest:
    None declared.
  • Published on:
    Re: Miller J et al, November 12th Publication

    In the November 12th issue the BMJ published a paper (Miller, J., et al) on "Clinical Trial Registration, Reporting, Publication and Food and Drug Administration Amendments Act (FDAAA) Compliance of Drugs Approved by FDA in 2012".

    In the paper the authors conclude that for Stribild, a drug for the treatment of HIV infection developed and marketed by Gilead Sciences, Inc., only 9% of clinical trials submitted to...

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    Conflict of Interest:
    None declared.
  • Published on:
    Transparency grade reflects only one aspect of transparency

    Imagine a drug company conducting 10 trials, 5 of which turn out positive and 5 negative. The 5 positive trials are, unsurprisingly, published. The 5 negative trials are subjected to outcome reporting bias, aka statistical alchemy and HARKing (hypothesizing after the results are known), so that they appear to be positive in the final publications. The downstream reader (or even systematic reviewer) is misled into believi...

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    Conflict of Interest:
    None declared.