[Ip-health] From 2006 to 2014, number of trials in ClinicalTrials.Gov doubled.

Jamie Love james.love at keionline.org
Thu Dec 17 01:30:07 PST 2015

*  From 2006 to 2014, the number of trials increased from 9,321 to 18,400.
*  Biggest drive of increase are 227 percent grown in trials funded by
"other sources" than US federal government or industry.
*  NIH trials down 24 percent, other federal up by 29 percent,.
*  Industry trials up 43 percent.


Reporting from the frontiers of health and medicine

Increase in industry-funded drug trials bad for public health, researcher

Over the past decade, the number of clinical trials for drugs that were
funded by the National Institutes of Health has dropped while the number of
studies financed by drug companies has risen substantially. This is not a
surprise, given the diminished NIH budget, but one researcher said this is
detrimental to public health.

Overall, the number of trials registered on ClinicalTrials.gov, the federal
database, doubled from 9,321 in 2006 to 18,400 in 2014, according to a
research letter published in the latest issue of the Journal of the
American Medical Association.

Breaking that down, the number of industry-funded trials during that period
rose 43 percent, while studies that were funded by the NIH fell by 24
percent. At the same time, financing from other federal agencies rose 29
percent and funding from still other sources — such as individuals,
universities and organizations — rose by 227 percent.

Read more: Law ignored, patients at risk.

Why might this matter?

Trials funded by drug makers may offer limited information, according to
Dr. Stephan Ehrhardt, a coauthor and professor of epidemiology at the Johns
Hopkins Bloomberg School of Public Health. Companies typically test their
medicines against a placebo in order to win regulatory approval, but this
approach may not give physicians enough information to make the best
treatment decisions, he said.“

Let’s say a company develops drug No. 121 for lowering blood pressure and
it was tested against a placebo, and is proven better,” he explained. “What
do I do with that information? There are 120 others out there. Which one do
I prescribe? For that answer, you need trials that compare different drugs,
which companies generally don’t do. For this, we need funding free from
commercial interests.”

He continued that industry-funded trials aren’t necessarily wrong, but “we
contend that the sharp decline in NIH-funded trials is not good for public
health because these are the trials that are most likely to inform decision
makers about the best treatment options for patients.”

Such notions are not new, but Ehrhardt noted the research appears to be the
first time that an analysis was undertaken to compare funding sources of
registered studies.

Read more: Congress ready to give NIH its biggest increase in 12 years

But with a possible boost to NIH funding, the tide may turn.

The 2014 NIH budget, which amounted to $30 billion, is 14 percent less than
the 2006 budget, when adjusted for inflation, but the NIH is slated to get
a $2 billion funding increase in the federal spending bill released today,
which would mark the first time in more than 12 years the agency budget
would receive such a big boost. Of course, this assumes the spending bill
is passed.

Ehrhardt suggested increased funding could be designated for specific
research. He also believes that industry should team more often with
independent investigators to run comparative studies. “The incentive to do
this comes from public pressure,” he said, “because every company is
interested in how they appear to the public. We need solutions and they
don’t want to be seen as part of the problem.”

Ed Silverman can be reached at ed.silverman at statnews.com
Follow Ed on Twitter @Pharmalot


James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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