ISTOCK, VIPERFZKIn recent years, a number of investigations revealed that clinical reporting practices failed to meet ethical and legal standards in both academia and industry. But an analysis published today (December 5) in BMJ Open suggests that some reporting practices have improved—at least at a few pharmaceutical companies—based on a comparison of trials linked to drugs approved by the FDA in 2012 and 2014.
“The good news is, for the trials that the companies conducted in patients to gain regulatory approval of their drug, [transparency levels] went up,” says study co-author Jennifer Miller, a bioethicist at New York University and founder of Bioethics International, a non-profit dedicated to ethics and transparency in the pharmaceutical sector.
Ethical standards endorsed by organizations such as the World Medical Association, the World Health Association, and the National Institutes of Health (NIH) include requirements that clinical trials be pre-registered in databases that record aspects of the trial such as the outcomes that will be used to determine an intervention’s success and failure, and that their results are reported even if they indicate a treatment doesn’t work. Such guidelines are intended to ensure that the ...
