Benjamin Speich and colleagues investigate whether rates of trial completion and publication have increased over the past decade, the extent to which non-published trials can be identified in registries, and the association between reporting quality of protocols and premature discontinuation or non-publication of trials.
Author summary Why was this study done? ➢ Clinicians and researchers depend on the peer-reviewed literature for accurate assessments of drug efficacy and safety, but this depends on whether the outcomes of all trials—negative, as well as positive—are reported transparently. ➢ In an earlier study, using Food and Drug Administration (FDA) review documents as a gold standard, we found that many negative trials had been misreported in the published literature as having positive outcomes or had simply not been published. ➢ Since then, reporting bias has been the subject of additional studies and policy changes, raising the question, Is the antidepressant literature now being reported more transparently? What did the researchers do and find? ➢ Using FDA reviews on 4 newer antidepressants, we identified 30 trials, half with positive, and half with negative, outcomes. ➢ Among the 15 negative trials, 6 were unpublished and 2 others were misre