What disclosure?: Half of European clinical trials are not being reported
Four years after clinical trial sponsors were told to report summary results in the European Union, half of the registered studies remain unreported, although drug makers are doing a much better job at disclosure than other organizations, a new analysis finds.
Specifically, only 51 percent of more than 7,600 clinical trial results have so far been reported since the European Commission issued guidelines in 2014. However, 68 percent of trials sponsored by the pharmaceutical industry have reported results, while only 11 percent of trials sponsored by hospitals, academics, governments, and charities have done so, according to the analysis published in BMJ.
The dismal reporting practices highlight an important and often contentious issue: Without access to published trial results, it can be virtually impossible for independent researchers to verify findings that can lead to improved treatments, better health care, and lower costs. Yet as the researchers in BMJ noted, no one has ever been sanctioned for breaking the European rules. [...]bioethics biotechnology clinical research health law policy human subjects research international medical safety pharmaceuticals public health regulation research