From 2006 through 2014, there was a decrease in newly registered NIH-funded trials, whereas industry-funded trials increased substantially, based on trials registered in ClinicalTrials.gov. The study appears in the December 15 issue of JAMA.
The National Institutes of Health (NIH) and the pharmaceutical industry have been major funders of clinical trials. In general, the pharmaceutical industry funds trials that test their own products, whereas the NIH's funding strategies are not commercially motivated. In 2005, registration of trials became required for publication in major journals. Stephan Ehrhardt, M.D., M.P.H., of Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues investigated trends in funding of trials using the NIH-built database, ClinicalTrials.gov, with a focus on NIH and industry funding. The researchers downloaded data from ClinicalTrials.gov, searched for "interventional study" and obtained counts of newly registered trials by funder type: "NIH," "industry," "other U.S. federal agency," or "all others (individuals, universities, organizations)."
Examining data according to the first received date, the number of newly registered trials doubled from 9,321 in 2006 to 18,400 in 2014. The number of industry-funded trials increased by 1,965 (43 percent). Concurrently, the number of NIH-funded trials decreased by 328 (24 percent). During this period of relatively few trials being funded by other U.S. federal agencies, funding from the all others category increased by 7,357 (227 percent). In a random sample of 500 trials in this category, a majority (353; 71 percent) did not have U.S. based funders. From 2006 through 2014, the total number of newly registered trials increased by 5,410 (59 percent) and that of industry-funded trials increased by 758 (17 percent). The number of NIH-funded trials declined by 316 (27 percent).
The authors write that the decrease in NIH-funded trials may have resulted from a decline in discretionary spending by the U.S. federal government. "The 2014 NIH budget is 14 percent less than the 2006 budget (when adjusted for inflation). An expanding portfolio of NIH research with a flat budget may also have contributed to the decline in NIH-funded trials."
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