Over the past decade, the number of privately funded clinical trials has nearly doubled, while the number of government-sponsored studies has fallen, according to a new report from Johns Hopkins University.
JHU researchers looked at newly registered studies on the ClinicalTrials.gov database between 2006 and 2014, an amount that rose from 9,321 to 18,400 in that timeframe. They found that while the number of trials backed by NIH fell 24 percent — from 1,376 to 1,048 — pharmaceutical companies sponsored 1,965 more trials — a 43 percent increase.
Budget constraints seem to have had an impact on the findings, particularly because clinical trials are very expensive. As the researchers note, the NIH budget shrank by 14 percent in the eight-year time period.
“It’s a bad situation [that’s gotten] worse,” Lawrence Appel, director of the Welch Center for Prevention, Epidemiology and Clinical Research at Johns Hopkins, and an author on the clinical trials paper, said.
Although drug companies and the NIH both make up the main financing for clinical research, the Johns Hopkins report also pinpoints a growing class of other trial sponsors, including government agencies, organizations and universities. Largely based outside the U.S., this third group paid for almost 10,600 studies in 2014. That number is up from 3,240 in 2006.
“In this climate, given these reductions, it’s very unlikely you’ll see many trials comparing several drugs,” Appel said. He added that with funding from NIH declining, those trials will be harder to conduct.
NIH Deputy Director for Extramural Research Michael Lauer acknowledged that financial constraints played a role in the decrease, adding that clinical trials on the whole have become increasingly elaborate and costly. “The combination of declining budgets and increasing costs would be expected to lead to fewer trials funded,” he wrote.
But he defended the agency’s record and approach — through initiatives like the Common Fund Collaboratory, Clinical Trials Transformation Initiative, Patient Centered Outcomes Research Institute and Clinical and Translational Science Awards program — to attempt to reverse that and renovate the types of trials conducted. “What we are after is an ecosystem in which we can fund more high-impact, cost-effective trials.”
Appel dismissed the idea that fewer studies could mean stronger, larger ones. “We found no evidence of that. The average sample size has not changed over time.”
The study can be accessed at http://jama.jamanetwork.com/article.aspx?articleid=2475454&resultClick=3.