Clinical trials are necessary, under pharmaceutical regulations, to test the efficacy and safety of new or modified medicines. Trials go through a number of phases, beginning with animals and culminating with tests on human subjects.
According to a report from Johns Hopkins University, the proportion from the U.S. National Institutes of Health (NIH) clinical trials, funded by major pharmaceutical companies, has risen each year since 2006 (and, conversely, the number funded by the NIH directly — and regarded as independent — has fallen).
Associated data indicates NIH funded trials fell from 1,376 in 2006 to 1,048 in 2014, a decline of 24 percent. Over the same period, the number of trials sponsored by pharmaceutical companies rose from 4,585 to 6,550. This is a rise of 43 percent. Data was extracted from the U.S. government repository — ClinicalTrials.gov — where information relating to many human clinical trials, carried out since 2005, are held. Companies do not have to deposit clinical trial data on the site; however, if the pharmaceutical company wishes to publish the outcomes then most academic journals will only accept papers from studies that are held by the U.S. government. This requirement has led to an increase in the number of studies registered.
The concern with the decline in the number of ‘independent’ trials relates to impartiality. Speaking with PharmaFile, one of the scientists responsible for the new research, Stephan Ehrhardt, noted: “given that the industry has a vested interest in the outcome of those trials, we don’t get good data to inform the health of the public.”
Ehrhardt went onto state that pharma-funded trials are narrower, focusing on gathering the data necessary for gaining approval from bodies like FDA. On the other hand, NIH supported studies look at wider health impacts.
The reasons may not always be due to pharmaceutical companies wishing to run their own studies, however, for cuts to NIH funding have meant there is less budget to run independent studies.
The new research is published in the Journal of the American Medical Association (JAMA). The paper is titled “Trends in National Institutes of Health Funding for Clinical Trials Registered in ClinicalTrials.gov.”