A new study in PLOS ONE found that, despite International Committee of Medical Journal Editors (ICMJE) guidelines, only one third of clinical trials published in the five most influential psychiatry journals were correctly registered before patient enrolment. In 2005, the ICMJE introduced the prospective registration guidelines, which led to many journals making prospective registration a condition for publication.
Looking at articles published in JCP, AJP, JAMA Psychiatry, BP and JAACAP between January 2009 and July 2013, researchers identified 181 studies as clinical trials that required registration. Of these trials, only 26 (14.4%) were prospectively registered and stuck to their original primary outcomes (the things they had decided to look at before collecting data). The study also found that industry sponsored trials were more likely to be registered prospectively with no switched outcomes.
Dr Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign:
“It’s extremely disappointing that prospective registration is not being properly enforced. Clearly, the journals have an important role to play in fixing the problem of withheld trial results, and it’s not enough for them to assume that their policies are working. Journals need to up their game, and produce audit data, annually, on how many unregistered and switched trials they publish. AllTrials will soon begin the process of grading medical journals against these standards. Until the problem is properly addressed, anyone reading a trial report in an academic journal needs to remain extremely cautious about checking for registration and outcome switching.”
The research has been nicely explained in a blog by Julia Rucklidge, co-author of the study.