U.S. researchers concerned about decrease in gov't-funded clinical trials

The number of clinical trials funded by the U.S. government has fallen substantially, while the number of industry-sponsored trials has increased dramatically since 2006, according to a study published Tuesday that led researchers to call for a discussion on how to best allocate U.S. health research budgets.

"My concern is that independent trials are on the decline and that means we have less high-quality data to inform public health that are not influenced by commercial interests," study leader Stephan Ehrhardt, an associate professor in the Johns Hopkins Bloomberg School of Public Health, said in a statement.

"When I am doing a government-funded trial comparing two treatments, I start with the assumption that both treatments are equal. I don't have a vested financial interest in the outcome," Ehrhardt said.

"But when I am a drug company testing my new product, my objectivity can be compromised by the company's bottom line since it costs me millions of dollars to develop and test my product to get it on the market. It might be difficult for me to be completely objective. The stakes are very high," he said.

In the U.S., the National Institutes of Health (NIH) and the pharmaceutical industry have been major funders of trials.

In general, pharmaceutical companies fund trials that test their own products, whereas the NIH's funding strategies are not commercially motivated. Results from NIH-funded trials often provide the basis for prevention and treatment recommendations.

For the study, Ehrhardt and his colleagues searched the NIH-built database, ClinicalTrials.gov, for "interventional study" and then searched by funder type for trials registered between 2006 and 2014.

The number of newly registered industry-sponsored trials increased 43 percent over the time period from 4,585 in 2006 to 6,550 in 2014. The number of newly registered NIH-funded trials decreased 24 percent over the same period from 1,376 in 2006 to 1,048 in 2014.

Both NIH and industry trials are required to be registered if researchers intend to publish the results.

Ehrhardt said he believes that the decline in NIH-funded studies can be traced to two things. One is the flat NIH funding, since the 2014 budget was 14 percent less than in 2006, after adjusting for inflation. The other is the greater competition for these limited dollars from other relatively new research areas such as genomic research or personalized medicine studies.

"We need a discussion on how to best allocate our health-related research budgets," he said. "What best informs public health? It's probably clinical trials in large populations, such as testing to see if a reduced-salt diet reduces blood pressure. That study changed the way people eat and helped to reduce hypertension in many people. Industry would never do that. They'd have no interest in a reduced-salt diet. There's no money in that."

The findings were published in the Journal of the American Medical Association. Enditem