Clinical Trials Program, Innovation Lab work in tandem to boost research efforts
Dr. Robert Goggs, associate professor at the Cornell University College of Veterinary Medicine (CVM), has many jobs. He has patients to see, students to instruct and supervise and research projects to design and monitor. In an ideal world, he would have the time, space and funding for a lab with postdocs, lab techs and sufficient equipment to help him conduct clinical trials and more detailed analyses of tissue samples.
Goggs does not live in an ideal world, however. “As you go from the simple observational studies through to a complicated clinical trial where you are providing a novel therapy and you're doing a whole bunch of sequential observations, sequential sampling, follow-up, you just can't undertake that as an individual faculty member with all of your other responsibilities,” he explains. Moreover, pharmaceutical companies aren’t as generous with grants to support medical research for animals as they are for humans.
Other faculty at CVM were in the same boat. So, roughly a decade ago, Lorin D. Warnick, D.V.M., Ph.D. ’94, the Austin O. Hooey Dean of Veterinary Medicine, who was then the director of the Cornell University Hospital for Animals, decided it would benefit everyone if researchers pooled their resources. In 2015, CVM started the Clinical Trials Program to help run and administer clinical studies. In 2021, the Department of Clinical Studies Research Committee established the Innovation Lab to provide extra assistance with molecular science.
The two programs work in tandem, though not always together. “We’re on the same overall team,” says Mike Byron, the manager of the Innovation Lab. “Our goal is to help assist research in our department in the veterinary hospitals. In some ways we’re quite different, but in other ways we overlap quite a bit.”
The Clinical Trials Program, which works directly with animals, primarily administers larger observational studies of new drugs and treatments. The Innovation Lab looks at these effects on a cellular level. Together, says Goggs, they allow CVM faculty to combine resources and work more efficiently.
The Clinical Trials Program
When Carol Frederick, licensed veterinary technician specialist, began running the Clinical Trials Program in 2018, there were eight studies running concurrently. Today, there are between 40 and 45, and that number continues to grow.
“It’s great for us,” she says, “it’s great for the pets and it's great for the clients when we can help provide either financial incentive or better therapy. Sometimes they get better faster, sometimes they don't. But either way, all of the information that we get will help future animals as well, which is fantastic.” Some of the studies are translational, meaning the findings can also be applied to humans.
The clinical trials investigate a wide range of things, among them the genetic basis of diabetes in cats, inflammatory bowel disease in both dogs and cats, chronic kidney disease in cats, a lower-cost treatment for canine lymphoma and the effects of a fecal microbiome transplant for dogs with epilepsy. Most of the subjects are small domestic animals and livestock, though occasionally researchers will work with wild animals: Frederick recalls one study of the best way to transport rhinos.
The team doesn’t work on every study every day. Sometimes there are lags because of the difficulty of finding test subjects. One study on cat diets took two-and-a-half years because it took that long to find 39 volunteer felines. The general public might not be aware that the veterinary college even does clinical studies, and most test subjects have to be recruited, either from among patients at the various Cornell animal hospitals, through local veterinarians or occasionally through ads in veterinary medical journals.
Researchers sometimes have to fight the conception that their projects actively harm animals. “It's very important to us to make sure that everyone understands the risks that are associated with the study,” says Frederick. “So all of our consent forms have all the risks lined out very clearly and all the benefits lined out very clearly. And we also want to make it very clear to our clients that this is a volunteer thing, and we are very appreciative. And they have the right to withdraw their pet from the study at any time.”
In general, Frederick says, the researchers tend to be fairly risk-averse. In her time in the Clinical Trials Program, she hasn’t yet come across a study she’s not comfortable working on. The university’s Institutional Animal Care and Use Committee (IACUC) ensures that the animals are treated well and that the researchers adhere to a few basic principles: reduce the number of animals in the study, reuse animals in multiple studies and refine the experiment to make sure the science is good before animals get involved. So far, no patients have died as a result of their participation in a study, though some have died due to the natural progression of their disease.
“Our goal is to make sure that people and their pets have better quality of life and that future pets have better quality of life,” Frederick says. “It's not research just for research's sake.”
The Innovation Lab
“A lot of the faculty here are clinicians and they spend a lot of time doing clinical work,” says Byron. “A lot of them don't necessarily have a lot of the hard science molecular science background. That’s where the Innovation Lab comes in. Our job is to provide that molecular science capacity.”
If the veterinary technicians in clinical trials are concerned with the big picture of the research projects and their effects on the whole animal, the techs in the Innovation Lab look at the tiniest details. They process tissue and blood samples and freeze them for future experiments. They look at cells and proteins under the microscope. They extract DNA. They’re adept at more complex procedures that may be beyond the training of the average clinician.
But the Innovation Lab is also a resource for clinicians who like doing their own bench work. It houses many large and expensive specialized equipment like centrifuges and thermocyclers and imaging machines and makes them available to researchers. And when, as often happens in research, things don’t go to plan, the Innovation Lab staff is available to discuss hiccups in the experiment and suggest solutions.
Troubleshooting is actually Byron’s favorite part of the job. “There's an answer in there somewhere, and we're going to find it eventually,” he says. “There's an answer to this problem.”
The Clinical Trials Program and the Innovation Lab are not unique to Cornell. Goggs says that several of the CVM’s peer institutions have similar programs and facilities. The need for a communal resource to provide extra hands for researchers has become a necessity of modern academic medicine, where funding can be limited. “You have to have teams of people to help you,” he says. “Otherwise, things fall through the cracks or you just miss patient opportunities.”
Goggs doesn’t necessarily regret the end of the old model of self-contained labs, though. He understands that successful research leads to more funding, which, in turn, leads to more research.
“That infrastructure really makes a huge difference to making us competitive for funding externally and, more importantly, to patients and clients,” he says. “We’re actually able to make a real difference in their patients' their animals' lives because the work that we're doing means we actually know more about the diseases that we're managing. We're in a better position now than we were months, years ago to make a diagnosis. And we have new treatments that have been developed as a result of work that we’re undertaking, that are changing the landscape for companion animal therapies.”
Written by Aimee Levitt