[Ip-health] Pharmalot/Statnews on McKinsey study on risks of trials: "More clinical trials are succeeding for the first time in years"
james.love at keionline.org
Mon Jun 13 11:36:10 PDT 2016
Ed Silverman reports on a McKinsey study of trial risks.
Cumulative success rates according to McKinsey:
1996 to 1999: 16.4 percent
2000 - 2003 10.8 percent
2004 - 2007 10 percent
2008 - 2011 7.5 percent
2012 - 2014 11 percent
Phase 2 to next round: 40 percent, up from 30 percent.
Phase 3 to approval, 64 percent, up from 60 percent.
More clinical trials are succeeding for the first time in years
By ED SILVERMAN @Pharmalot
JUNE 13, 2016
After years of declines, the pharmaceutical industry is experiencing a
greater rate of success with its clinical trials in recent years, according
to a new analysis.
Between 2012 and 2014, more than 11 percent of clinical trials succeeded,
which meant compounds being tested survived the arduous journey from the
laboratory to the pharmacy counter. This reversed a downward trend seen
over the past 20 years, according to executives at McKinsey & Co., the
consulting firm that conducted the analysis and does consulting work for
Between 1996 and 1999, the cumulative success rate was 16.4 percent, but
gradually began declining in subsequent years. From 2000 to 2003, 10.8
percent of trials succeeded before falling to 10 percent between 2004 and
2007, and then bottoming out at just 7.5 percent between 2008 and 2011.
“In some ways, this is rather remarkable,” said Martin Moller, one of the
coauthors, who heads McKinsey pharma R&D consulting in Europe, the Mideast,
and Asia. “We’ve been used to seeing a decline. This is a turning of the
trend. Whether that is sustainable is an open question.”
The analysis, which was published last month in Nature Reviews Drug
Discovery, examined more than 9,200 novel compounds that were developed
from 1996 through 2014.
The declines in past years likely reflected industry cutbacks, according to
the McKinsey consultants.
>From 2007 through 2010, many drug makers were cutting back on R&D amid
large mergers and reorganizations that resulted in what was described as
“pipeline pruning.” Basically, most of the largest companies turned their
backs on researching medicines for combating certain diseases and became
much more selective about how they invested their research dollars.
For this reason, the McKinsey team suggested the more judicious use of
resources resulted in higher quality product pipelines which, in turn,
could account for the improved showings in clinical trials. The larger
proportion of failing compounds in Phase 1, or early-stage trials, may
indicate that companies are running more thorough evaluations and doing so
“Basically, the industry is learning how to fail earlier,” said Moller.
“And that’s a good thing.”
This could be seen by looking at data for both Phase 2 and Phase 3, or mid-
and late-stage, studies. From 2012 through 2014, the likelihood that a
Phase 3 study would advance to product registration was 64 percent, up from
60 percent during the previous three-year period. Similarly, the odds of a
Phase 2 study moving to the next round was nearly 40 percent, up from about
30 percent during 2007 and 2010.
There was a caveat, though. The increasing success rates for midstage
trials may be slightly inflated not only because there are more life-saving
medicines being shepherded to later-stage trials thanks to new trial
designs, but also because of breakthrough regulatory mechanisms. “Such an
approach carries a risk of a later-stage failure,” the consultants wrote.
For instance, drugs that were developed for treating rare diseases, which
can benefit from speedier development paths, had a higher overall success
rate from Phase 2 to regulatory approval. During the past three years, this
amounted to 29 percent compared with 10 percent for drugs used to treat
other maladies. In Phase 3 trials, the success rates were 73 percent and 64
James Love. Knowledge Ecology International
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