Sep
25
2012

As veterinary medicine advancements continue to accelerate, the clinical trial process has been forced to try to keep pace.

However, organizations looking to conduct relatively speedy clinical trials often get stuck playing the “hurry up and wait” game while searching for trial sites. The larger the study, the more time it generally takes to locate multiple sites and negotiate terms with each one.

To Dr. Philip Bergman, VCA director of clinical studies, there was one fairly obvious solution sitting right in front of him: leverage the extensive hospital network that VCA has spent years building.

“When you have 600 hospitals, of which about 10 percent are ER/specialty hospitals, you have the ability to do these trials internally and externally in a good way,” Bergman said. “I threw an idea at the management for VCA to start a clinical studies program that would encompass these externally funded types of trials for pharmaceutical companies, as well as ramp up for things we were doing internally.”

This idea led to Bergman’s recent announcement at the Kansas City Area Life Sciences Institute Research Symposium that VCA’s new clinical studies program will enable pharmaceutical companies to conduct their trials within the VCA private practice network.

According to Bergman, VCA’s effort to streamline the site-finding process is part of a growing trend of trials being coordinated by private companies rather than academic institutions.

Shifting from academic institutions to private practices
Academic institutions have historically hosted complex trials, but Bergman said there are several areas of inefficiency or cost-ineffectiveness that go along with that practice.

For example, veterinary schools often want a “piece of the IP pie,” according to Bergman. If the trial ends up producing a successful medication, the school might request a royalty payment, which can require time-consuming negotiation with the school’s attorney. Many academic institutions also negotiate an overhead charge that can range from 30 to 50 percent of the study’s cost.

Because VCA is a private entity, Bergman said it is able to negotiate the use of clinical trial sites without building certain fees into its pricing model that are often seen with academic institutions.

“In private practice, our goal is to give them a large number of participants,” Bergman said. “We don’t have an interest in the IP pie and we don’t charge overhead because our costs are our costs whether they are paid by the client or the research study. Our goal is to move veterinary medicine forward.”

Becoming a one-stop shop for clinical studies
With a large hospital network encompassing general practice and specialty clinics, VCA has the resources to handle studies ranging from less complex trials such as analgesic drugs to more elaborate studies such as cardiovascular drugs, Bergman said.

By tapping into the network for even large-scale studies, Bergman claimed that pharmaceutical companies can avoid stress and save money.

“One problem is that these pharmaceutical companies - if they have a 20-site trial - they have the financial, emotional, and logistical burden of negotiating,” Bergman said. “Now they just come to one person, and then we’re able to do that negotiation and farm that out to different sites. It’s financially better and easier for them, and an opportunity to advance veterinary medicine.”

In addition to streamlining the site-finding process for pharmaceutical companies, Bergman speculated that his program may also contribute to more accurate studies. He said many clinical trials aren’t conducted optimally because they don’t get enough patients participating, but VCA’s high patient volume can help to increase studies’ sample sizes for more reliable data.

VCA also has Antech Diagnostics as a laboratory partner, which Bergman said helps to ensure GLP (good laboratory practice) data and ensure general quality control.

Getting off to a fast start
The clinical studies division at VCA has only been operating for a couple of months, but is already in the midst of initiating an FDA trial at four VCA sites. The division also plans on meeting with major pharmaceutical partners toward the end of 2012 in order to share further details about the program, according to Bergman.

Although the program is still in its infancy, Bergman acknowledged that he is encouraged by early results.

“It’s taken off much more quickly than even I thought it would,” he said.

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