A new study shows that while clinical research funded by industry groups is growing at a fast clip, research paid for by the government is dropping. Findings published Tuesday in JAMA show that between 2006 and 2014, the number of trials paid for by industry rose 43% while those funded by the National Institutes of Health dropped 24%.
Researchers say industry-sponsored trials concentrate on commercial purposes, while independent studies better inform the public by comparing those products with existing alternatives, like other drugs and lifestyle or dietary interventions.
“Those kinds of trials are not typically funded by industry,” said study co-author Dr. Stephan Ehrhardt, associate professor in the Johns Hopkins Bloomberg School of Public Health. “But they really inform the health of the public, and answer more than 'does a drug work, yes or no?' ”
Trials conducted by for-profit organizations are also more likely to only report positive outcomes. Lastly, the findings speak to other ongoing criticisms about the costs, review process and other limitations of clinical research in the U.S.
Of 18,400 trials registered in 2014 on clinicaltrials.gov, the federal registry and results database of clinical studies involving human participants, more than a third were sponsored by drug or device manufacturers, according to findings.
There has been mounting concern by patient safety advocates over the past decade that too often adverse events are under-reported by researchers. That issue was tackled by the National Academy of Medicine in January when the group issued four recommendations to address practices that left relevant medical research unpublished. Independent researchers wishing to make comparisons said they couldn't access important and relevant data.
But the “failing to report” problem is not just limited to industry. A STAT news investigation published this week found some of the worst offenders included academic institutions that are top recipients of NIH funding.
The 21st Century Cures Act, recently passed by the House, added a new element of worry. The bill would provide an additional $9.3 billion over the next five years to fund the NIH and support breakthroughs in biomedical research, and allow the agency to speed up the review and market approval of breakthrough drugs. Critics worry, however, that the bill relies too heavily on post-market surveillance for flagging adverse events, a system that has proven to be ineffective.
In the meantime, the number of newly registered trials on the government's clinical trial database has doubled over the past decade. The research letter posted Tuesday in JAMA found that the number rose from 9,321 in 2006.
“There is now more competition for limited dollars,” said Ehrhardt. “That leaves less space for these relatively important trials that inform public health.”
The authors also evaluated whether during the time that the NIH funded fewer studies, the agency had become more selective in terms of the size and scope of the limited studies selected. They looked at the median sample size of NIH funded trials across the years and found no difference.
The NIH agreed that budget constraints in part explain the decline, but also said it has been proactive in figuring out ways to make trials faster, better and less expensive.
According to a 2014 report from HHS' Office of the Assistant Secretary for Planning and Evaluation, cost is one of the major obstacles to conducting clinical trials in the U.S. The estimated cost of bringing a new drug to market can range from $161 million to $2 billion.
“What we are after is an ecosystem in which we can fund more high-impact, cost-effective trials,” said Dr. Michael Lauer, NIH deputy director for extramural research via e-mail.
It's not just about raw counts of trials, but other deeper measures of investment and impact, he said. “We think about costs, cost per patient enrolled, speed of completion and publication, rate of dissemination, and impact on practice and policy.”
The agency says it offers funding opportunities for low-cost, pragmatic, patient-centered randomized controlled intervention trials and is also an active partner in the Patient-Centered Outcomes Research Institute.
PCORI, an independent organization created through a provision of the Affordable Care Act, supports research that assesses which healthcare interventions are most effective. Since it launched in 2012, the institute says it has approved $1.18 billion in funding for 468 patient-centered outcomes research projects.
The studies it funds look at both patient and stakeholder engagement, and offer comparisons of therapies of all kinds, including drugs, devices, lifestyle interventions, care delivery models, surgical procedures and behavioral health therapies. However, the group has been criticized because the funding program does not support applications to conduct studies of cost-effectiveness.
Ehrhardt says questions about what to research reveal another concern: What ultimately constitutes a good study in the first place? He agrees with concerns raised by ethics researchers and others in a recent Modern Healthcare report highlighting potential problems in the research review process. “We don't even know what a good ethical review is; we don't have quality criteria,” he said.
