Kenneth A. Getz
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The privatization of clinical research is widely known. Up until the early 1990s, academic medical centers (AMCs) were the
primary and predominant home of industry-sponsored clinical trials. As these programs became larger and more complex and costly,
industry sponsors grew tired of the inherent inefficiencies in working with academia, including protracted contractual and
budget negotiations, bureaucratic and slow-moving institutional review boards (IRBs), and higher relative costs associated
with poorer performance.
Community-based for-profit investigative sites rapidly filled the void. Most notably to support Phase III programs, industry
sponsors engaged ever-higher numbers of private physician practices and dedicated research centers to conduct their clinical
trials. AMCs remained involved, to a lesser extent, by virtue of their vast scientific expertise, reservoir of ideas and intellectual
property, and their influence as thought leaders.
Figure 1
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Today, only one-third of all industry-funded clinical trials are placed within academic clinical trial offices, according
to the latest data from the Tufts Center for the Study of Drug Development [see Figure 1]. During the past decade, AMCs have
lost nearly 40 percentage points in market share of total industry sponsored clinical trial grants. For many AMCs, the fall
from a market-leading position is without regret.
Whereas the mid-1990s saw a flurry of academic institutions establish clinical trial offices to better handle industry relationships,
the late 1990s through mid-2000s saw a reversal of that trend. AMCs cite a number of explanations for this shift, including
poor returns on infrastructure investment, lack of institutional support, and renewed emphasis on the more prestigious government-funded
clinical research programs. During the most recent five-year period between 2002 and 2007, total funding by the National Institutes of Health (NIH) grew
nearly 4% annually to $28.8 billion FY2007. Next year, however, the Bush administration has abruptly halted this growth in
proposing a 2% decline in the NIH budget (FY2008 $28.3 billion). That is just the tip of the iceberg. The NIH is beginning
to phase out its long-established General Clinical Research Center (GCRC) program and is moving to a new Clinical and Translational
Science Awards (CTSA) model. The result will be an intensification of competition specifically for NIH clinical research grants.
Many within academic circles are turning their eyes again toward industry-sponsored clinical trials as a vital source for
much-needed financial resources in the near future. Fortunately, many clinical research professionals within pharmaceutical
and biotechnology companies remain interested in forging, and in building, stronger relationships with academia. Indeed, a
number of major sponsors including Novartis, AstraZeneca, Lilly, and Merck have been giving partnerships with AMCs greater
attention.
Need and potential
"Leading AMCs have done an excellent job of making course corrections," says Ellis Wilson, section director for CV and GI
at AstraZeneca. "We're seeing a growing number of AMCs paying more attention to industry, and that is a very positive development."
"At this time AMCs are not as competitive as they could be, but they hold a great deal of potential," says George Betts, executive
director, U.S. medical operations for Novartis. "They have so many patients that could be eligible for clinical trials. This
is not just a benefit for major drug companies. It also gives patients access to drugs not yet available on the market," he
said.
"[But] AMCs that want to be back in the game need to be more efficient," said Betts. "Minimizing delays due to drawn-out negotiations
over intellectual property rights would be a good place to start. And coming to terms on contractual agreements rarely goes
smoothly. New lawyers cycle in and want to renegotiate everything for the AMC. Slow IRB review is also a perennial problem
in desperate need of attention," he said.
