Despite updated standards requiring preregistration of clinical trials aimed at improving transparency, most studies published in the top-5 psychiatry journals from 2009 to 2013 do not meet the new guidelines, according to an analysis published in PloS one.
For the first time researchers have examined whether the 2005 International Committee of Medical Journal Editors (ICMJE) standards, which address selective outcome reporting and bias in the medical literature, are being implemented by researchers and enforced by journals.
The researchers, Amelia Scott, Julia Rucklidge, and Roger Mulder, sought to determine whether clinical trials being published in top psychiatry journals were being correctly preregistered, and whether they had changed their primary outcome measures (POMs) and/or their proposed time frames for treatment effectiveness.
Out of 181 studies requiring prospective trial registration published in the top 5 psychiatry journals between January 2009 and the end of July 2013 only 60 studies (33%) were correctly registered with clear POMs. Of the rest, 21 were unregistered, 17 had unclear primary outcome measures, 61 had been retrospectively registered, 20 had unclear assessment times and 2 had unavailable protocols.
Not all of the correctly registered studies were up to standards, however. Seventeen out of the 60 correctly registered studies showed discrepancies between the POMs in the preregistration and the published article. The researchers determined that 7 studies had altered their measures “to favour statistically significant results.”
Overall, the research revealed that “less than 15% of psychiatry trials were prospectively registered with no changes in POMs.”
The researchers also showed that studies funded by pharmaceutical companies were more likely to be correctly registered with no changes to POMs than private trials.
They conclude: “Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.”
For an in-depth description of this study see Julia Rucklidge’s latest contribution to MIA’s Featured Blogs here →
Scott, A., Rucklidge, J. J., & Mulder, R. T. (2015). Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration. PloS one, 10(8), e0133718. (Full Text)