Lisa Henderson
|
It's true. What many have pitted as perennial foes in the battle for industry-sponsored drug trials—with the Academic Medical
Centers (AMCs) as underdog—is changing. What history may show in regard to the use of AMCs in industry-sponsored drug trials
remains to be seen. But in just the past few years, there has been a recent upswing among CROs and AMCs that are collaborating.
This requires an adaptation to business relationships on both sides of the fence, but is occurring to meet the needs of the
evolving drug development market.
And what are the drivers of collaboration? For the CRO, drivers of collaboration with AMCs may include greater access to specialized
expertise for specific therapeutic areas, the ability to take advantage of certain AMC-developed tools, or the opportunity
to provide sponsors with additional benefits through expanded access to investigator sites and patients. For the AMC, the
ability to be on the cutting edge of drug development remains paramount. For the industry at large, most have recognized that
the blockbuster drug is becoming a business model of the past. "The world is realizing it is very expensive to get drugs to
market," Josef von Rickenbach, chairman and chief executive officer of Parexel told Applied Clinical Trials.
"In order to develop drugs more effectively, the industry needs to identify where more efficiencies can be gained." He said
that the trend toward targeted treatments combined with the constricting health care dollar, means that more fragmented markets
don't have the resources to absorb development costs.
In early December, Parexel announced its alliance with the Safe Implementation of Treatments in Stroke (SITS) International,
a network of clinical sites specializing in stroke. In a release, the CRO included the following benefits of the alliance
to its clients: accelerated study start-up, patient recruitment, and specialized capabilities to execute stroke-related studies
on a global basis. "In joining forces with Parexel, SITS looks forward to furthering the growing field of stroke research
and speeding the introduction of important treatments to patients," said Nils Wahlgren, MD, PhD, and Chairman of SITS in the
release. Von Rickenbach, commenting prior to the announcement of the alliance, told us that the CRO intended to continue its relationships
with AMCs in many forms. Specifically of the SITS alliance, von Rickenbach noted that it "highlights an approach we are applying,
a more constructive way we have developed to work with academia." Parexel has had numerous successful relationships with AMCs
over its 25 plus years. "The collaborations between CROs and academic medical centers have waxed and waned over the past
couple decades," von Rickenbach noted. "But the number of these relationships has grown in the past few years." The company
will continue to identify strategic opportunities to create alliances with effective AMCs.
Cutting-edge research
FDAs Angle
|
"In order for us to keep our edge as a tertiary medical center, we have to do research," said Janis M. Orlowski, MD, senior
vice president and chief medical officer, Washington Hospital Center (WHC) located in Washington, DC, and part of the MedStar
Health System.
"We are looking to partner into higher impact, high quality trials," Dr. Orlowski told Applied Clinical Trials. "Our investigators have done a study here, one study there. With Quintiles, they bring us a portfolio of studies they are
working on, and let us choose from that portfolio." Orlowski maintains this is different from the investigator-initiated or
industry-initiated trials where "you're either in or you're out." Orlowski was impressed with both the quality of investigators
that would be involved as well as the quality of the clinical research Quintiles was doing.
