Since 2006, the number of industry-sponsored clinical trials has increased substantially while the number of trials funded by the National Institutes of Health (NIH) has decreased, according to research by Johns Hopkins Bloomberg School of Public Health.
“The growing imbalance between funding is of concern,” the study’s leader, Stephan Ehrhardt, MD, MPH, an associate professor in the Bloomberg School's Department of Epidemiology tells OutSourcing-Pharma.com. “The balance needs to be right.”
The findings, which were published yesterday in the Journal of the American Medical Association (JAMA), analyze funder types as they are listed on ClinicalTrials.gov from 2006 to 2014.
According to the research, the number of newly registered industry-sponsored trials increased 43 percent from 4,585 in 2006 to 6,550 in 2014. Conversely, 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).
What’s the big deal?
“Clinical trials are the backbone of evidence based healthcare and prevention,” says Ehrhardt, who explains that while industry funded trials are important – they generally test their own products.
“What we need to inform public health are trials that do head to head comparisons of medicines,” he adds. For example, drug trials that compare medications against lifestyle regimens, and medical intervention versus surgical treatment.
“These types of trial are free from commercial interest … The industry isn’t interested in comparing newly developed expensive drugs against a sodium reduced diet.”
In 2014 the NIH budget was 14 percent less than it was in 2006 (after adjusting for inflation). Additionally, there has been greater competition for funds as new research areas emerge, such as genomic research and personalized medicine studies.
In order to rectify the imbalance, Erhardt explains that one way to be increase NIH budget; however, this may not be a realistic solution. Instead, he suggests a more pragmatic approach: encouraging more collaboration between academic investigators and the industry.
When asked his thoughts on the recent report, Dr. Michael Lauer, NIH deputy director for extramural research, tells us, that while he agrees with the author's conclusion that budget constraints play a part in the decline of NIH-funded trials – there is more to the story.
“Another critical component is the cost of trials,” Lauer explains. “There is extensive documentation through government-funded reports that trials have become increasingly complex and expensive.”
According to Lauer, this combination of declining budgets and increasing costs would naturally lead to fewer trials funded. However, NIH has been pro-active in combatting these issues.
“The NIH Clinical and Translational Science Awards program is taking active steps to improve trial efficiency,” says Lauer. “What we are after is an ecosystem in which we can fund more high-impact, cost-effective trials.”
NIH has also funded the Common Fund Collaboratory, and several NIH institute and centers have participated in a funding opportunity for low-cost, pragmatic, controlled intervention trials. Additionally, NIH is an active partner in the Clinical Trials Transformation Initiative and in the Patient Centered Outcomes Research Institute (PCORI) network known as PCORnet.
“When we think about trials, we not only should focus on raw counts of trials, but other deeper measures of investment and impact,” adds Lauer. “Thus, we think about costs, cost per patient enrolled, speed of completion and publication, rate of dissemination, and impact on practice and policy.”