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Choosing
the right site for a clinical trial can hugely
accelerate recruitment, according to a new
benchmarking study by consulting firm KMR Group. And
this is just one of several factors that pharma
companies are scrutinizing much more closely as they
continue to feel pressure to reduce trial cost while
improving efficiency.
Says
David Spaight, president of MDS Pharma Services,
“The industry is taking measures to improve
efficiencies in the clinical trial process. A number
of companies have adopted global approaches to
streamline practices.”
Quintiles
agrees. “Companies are striving for more efficiency
in study conduct, part of which involves analyzing
site-performance data,” says Adam R. Chasse,
director of global access to patients. “Different
companies are farther along than others,” Chasse
adds.
KMR’s
recently completed study of site-performance metrics
points to some interesting developments. Says Scott
Martin, a principal at the firm, “There’s a
growing trend toward systematically collecting and
analyzing site data to more effectively manage trials.
Companies came to us and said, ‘We want broad
industry data to help us put our own performance into
context.’ That goes directly to the point that this
is an area of interest.”
The
study used data from major biopharmaceutical studies
carried out at more than 16,000 unique sites
worldwide, over the past few years. While data were
blinded, contributing companies were aware of who else
participated. “They can take it back and say, ‘We
looked at these companies that we consider our peers
to see how we’re doing in comparison’,” says
Martin.
KMR
analyzed dozens of site-performance metrics, examining
data by location as well as by disease area. Says
Martin, “If a company finds that it’s not stacking
up compared with its peers in a given disease area, it
can evaluate ways to raise its performance (e.g., by
figuring out how to get more subjects per site). If a
company can achieve its clinical endpoints with fewer
sites and still get satisfactory statistical results,
it gains efficiency over time. So there is a lot of
consideration going into how many sites a company
chooses and where they are located.”
Location,
Location, Location
In
fact, KMR found that geographical region can have a
profound effect. In Eastern Europe, for example, the
volume of patients randomized per site for
cardiovascular studies is more than 200 percent higher
than in North America In another example, the
accompanying figure shows trials for breast cancer
randomize greater numbers of patients per site
depending on region.
Site
novelty is another influential angle. KMR found the
number of patients randomized per site can vary
depending on whether a company has worked there in the
past. Using cardiovascular again as an example,
KMR’s analysis revealed that, overall, a company
using a site for the first time randomizes 15 percent
fewer subjects than if it had prior experience at that
site.
As
Martin points out, “Much of these data are valuable
not only for future planning, but operationally during
the course of a study.” For example, if a company
discovers after the first quarter of a two-year trial
that its monthly randomization rate is dramatically
lower compared with the industry median (based on site
location and disease indication), it may decide to get
more sites up and running. “A company can use the
intermediate data to try to figure out why it is
randomizing fewer subjects and take ad hoc steps to
overcome a slow start,” adds Martin.
In
the past, these matters weren’t centrally tracked
and systematically monitored. According to Martin,
“The trend we see is a greater appreciation of the
value of tracking this kind of information centrally,
and disseminating it to trial planners so they can
make more effective decisions.”
Spaight’s
observations corroborate this trend. “Most companies
are moving toward centralizing their working
processes,” he says. “Knowledge of past experience
and potential pitfalls is crucial to developing
metrics to track project milestones effectively.”
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A
STRIKING EFFECT: Study site strongly influences
success in patient recruitment.
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