Tag Archives: BMJ

Moving Towards Greater Transparency – One Step At A Time, Inexorably

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Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will make access to trial source data a requirement, as a condition of publication, arguing that patients and the scientific community have a right to this Continue reading Moving Towards Greater Transparency – One Step At A Time, Inexorably→

No Such Thing as a Free Ride…

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..when it comes to FDA review of antibiotic NDAs.  Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.  Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…→

And the Results are …Pending

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The website “ClinicalTrials.gov” has become the first stop for many of us who need to check on trial activity of a particular drug.  All larger human Phase 2 – 4 trials are listed there in quite some detail.  While companies sometimes shy away from publishing full entry criteria or primary Continue reading And the Results are …Pending→