Industry-paid clinical trials have grown dramatically in number since 2006, while the National Institutes of Health sponsors substantially fewer studies of drugs and medical treatments, a study finds.
The imbalance—with more and more research funded by drug companies or other businesses with a vested interest in the conclusions—could call into question the impartiality of clinical trial results, the researchers say. Those results help doctors determine what treatments or prevention measures to recommend for their patients.
“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,” says Stephan Ehrhardt, associate professor of epidemiology at the Johns Hopkins University Bloomberg School of Public Health.
The potential problem, he says, is growing influence for clinical trials paid for by biased companies and a dilution of the impact of government-funded trials.
“When I am doing a government-funded trial comparing two treatments, I start with the assumption that both treatments are equal,” says Ehrhardt, leader of the new study in the Journal of the American Medical Association. “I don’t have a vested financial interest in the outcome.
“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.”
Ehrhardt and his colleagues looked at studies registered in ClinicalTrials.gov. The number of newly registered industry-sponsored trials increased 43 percent, from 4,585 in 2006 to 6,550 in 2014. Newly registered NIH-funded trials decreased 24 percent, 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. ClinicalTrials.gov is the world’s largest online registry.
Clinical trials are research studies conducted in human subjects; they take many forms. In general, trial participants agree to be randomized to receive either a new therapy or a conventional therapy (or placebo). Some trials test three or more interventions. While many trials test new drugs, trials can also test treatment approaches (medical therapy versus surgical therapy) or lifestyle modifications (one diet versus another). Pharmaceutical companies generally test their own products.
Ehrhardt says he believes that the decline in NIH-funded studies can be traced to two things: First, there has been a decline in NIH funding (the 2014 budget was 14 percent less than in 2006, after adjusting for inflation). Second, there has been greater competition for limited federal 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,” Ehrhardt says.
“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.”
Source: Johns Hopkins University