Conducting clinical studies in the primary care environment

Veterinary clinical trials aren't just for veterinary teaching hospitals and research facilities. Increasingly, these studies have branched out in the primary care setting as another path for partners in the veterinary industry.

Conducting clinical studies is often a rewarding process for clinicians, says Dr. Craig A. Clifford, a medical oncologist at BluePearl Pet Hospital in Malvern, Pennsylvania. He presented the session, "Clinical Studies in the Primary Care Setting: How Do I Get Involved?" on July 17 at AVMA Convention 2023 in Denver.

Dr. Clifford is also director of BluePearl Science, a division of BluePearl, that coordinates clinical studies investigating the potential effectiveness of new veterinary drugs, diagnostics, treatments, and protocols intended to improve pet health.

Dr. Clifford said some practitioners thrive on the opportunity to offer patients novel therapies. Clinicians often pursue clinical studies because they want more variety than seeing and treating standard patients.

Others enjoy having an academic edge and the chance to gain prestige within the field from future publications and lectures. Financial motivation is another reason. Funded trials can generate money for the practice, and clinicians are typically making more during clinical studies than they would in hourly private practice. Not to mention, these studies can also help owners with limited means.

Similarly, hospitals and clinics benefit from participating in clinical studies. Involvement elevates the clinician and the practice, separating it from others. In Dr. Clifford's experience at a hospital conducting clinical studies, 20% of clients are self-referrals.

Trial data can be presented at conferences and published as well as serve as a possible recruitment tool for like-minded clinicians and staff. Veterinary technicians and other staff members can take the opportunity to differentiate themselves by participating in a research trial and gaining additional experience.

How to get started

To run a clinical study, a hospital needs to provide the following:

• An upper-level manager responsible for signing the research and nondisclosure agreements.
• Adequate support staff to help with client inquiries regarding studies, marketing and outreach, study paperwork, maintenance of trial binders, and data storage and protection.
• Infrastructure to support running studies.
• Scheduling adjustments for clinic support staff members to allow for trial cases needing more time than traditional outpatient cases.
• Budgetary considerations to ensure the clinic staff members are compensated for any extra work or additional time spent.

"It is extra work, but there are major benefits that come with it," Dr. Clifford said.

Animal-owner participation

Dr. Clifford emphasized that clinicians must consider the owner's perspective that pets are thought of as family whose medical needs merit quality care.

"Attitude is everything," he said. "These are people's pets—not research animals. Treat them the way we would any patient of ours."

To that end, when considering participation in a clinical study, clinicians should consider what preclinical studies have been done that demonstrate potential efficacy for an experimental therapy, including whether the therapy has been studied in animal models prior to use in client-owned animals. Clinics participating in clinical studies can establish internal review boards that consider such evidence. Some pharmaceutical companies and contract research organizations may already provide Institutional Animal Care and Use Committees (IACUCs) for conduct of clinical trials.

Lastly, owners should be informed of all potential risks—in addition to potential benefits and subsidies—as part of an informed consent process prior to enrollment of their animal into a clinical trial.

Participation in some clinical trials, such as those studying drugs for Food and Drug Administration (FDA) approval, may require personnel training in good clinical practice (GCP)—modeled after standards for humans—which assures that the clinic is maintaining trial integrity. Even if not required for a particular study, GCP is a good ethical and scientific quality standard for veterinary clinical studies.

"Clients want to be assured that you're doing it properly. So that's why going through this sort of training for each type of study is quite important," Dr. Clifford said.

How to get involved

Many ways exist to get involved in clinical studies. Dr. Clifford suggests the Comparative Oncology Trials Consortium or AVMA Animal Health Studies Database. Owners of privately owned hospitals can contract research organizations such as ACI, Agenta, Vetpharm, Veterinary Research Management, or sponsors such as Zoetis, Elanco, or Boehringer Ingelheim. Those at corporate practices, such as BluePearl or VCA Animal Hospitals, can contact their supervisors.

In discussions with management, clinicians can highlight the benefits of clinical studies, including that studies generate hospital revenue as many studies are fully funded and pay higher than the current cost structure. Marketing of the trial will help raise the profile and perceived prestige of the hospital.

In addition, Dr. Clifford observed that for many clinicians, participation in the generation of new knowledge sparks their interest and it gets them interested in veterinary medicine again.

A version of this story appears in the October 2023 print issue of JAVMA