AVMA launches database of clinical studies
The AVMA launched the AVMA Animal Health Studies Database in June as a resource for researchers seeking animals to participate in clinical studies and for veterinarians and animal owners exploring options for treatment.
Until now, there really haven’t been any national databases for veterinary studies, other than the Veterinary Cancer Trials website focusing on cancer in cats and dogs, said Dr. Ed Murphey, an assistant director in the AVMA Education and Research Division. The new AVMA website encompasses all fields of veterinary medicine and all species of animals and will extend beyond the United States to Canada and the United Kingdom.
“There are a lot of AVMA members that are involved in the conduct of clinical studies, and so, having the database helps them enroll animals into their studies,” Dr. Murphey said. “And there’s a direct benefit to practitioners who are looking for all avenues to help some of their owners and patients.”
He continued, “Then there is an indirect benefit, too, and that’s the advancement of evidence for the practice of veterinary medicine. Clinical studies, in particular clinical trials, are really the most informative and most scientifically accepted evidence for whether things work or don’t work in clinical practice.”
The new database is the brainchild of the AVMA Council on Research. In April 2014, the AVMA Executive Board, later renamed the AVMA Board of Directors, approved a recommendation from the council to form a working group to study the feasibility and development of a national registry of veterinary clinical trials.
The AVMA Animal Health Studies Database will be a centralized collection where it will be one-stop shopping for people with animals with certain conditions who may be interested in trying to find out if there are any studies that may either help their animal or may at least help direct the advancement of knowledge for the condition.
Dr. Ed Murphey, an assistant director in the AVMA Education and Research Division
Dr. Murphey said the group members looked at whether a clinical trials database was needed and whether it would be of value to AVMA members, then hammered out what it would look like and how it would function.
The working group recommended in July 2015 that the AVMA should forge ahead, and the Board agreed. Along the way, the group expanded the concept from a clinical trials database into a clinical studies database. The database covers not only randomized controlled clinical trials but also prospective clinical studies and survey and epidemiological studies.
Dr. Murphey said investigators might want to study a drug, surgical technique, or other treatment for a certain condition in animals. It could be as simple as wanting to collect samples from animals with a certain condition for DNA analysis. The investigators develop criteria for the animals, such as condition, age, or breed. Then the investigators put out a call for participation.
“There have, to this point, been limited opportunities for them to do so,” Dr. Murphey said. “A lot of the universities have a website, and they may put that on the website, but that’s highly dependent upon animal owners going to that university’s website and discovering it, so that’s not a very effective method. The AVMA Animal Health Studies Database will be a centralized collection where it will be one-stop shopping for people with animals with certain conditions who may be interested in trying to find out if there are any studies that may either help their animal or may at least help direct the advancement of knowledge for the condition.”
Animal owners, veterinarians, and anyone else can search the database. Because of a concern about owners contacting an investigator while leaving their veterinarian out of the loop, the website emphasizes that owners interested in a study should discuss with their veterinarian whether the animal is eligible.
Ahead of the launch, the Veterinary Cancer Society transferred all the studies from its Veterinary Cancer Trials website—about 100—into the AVMA database. The AVMA also has been soliciting studies by reaching out to veterinary colleges.
Dr. Kim A. Selting is the creator of the Veterinary Cancer Trials website as well as a member of the AVMA working group and an associate teaching professor at the University of Missouri College of Veterinary Medicine. She started working on the cancer trials website more than a decade ago.
“To do good-quality clinical trials, we need to have the right candidates. So if we pick the cases that we are most interested in, that will give us the information that we need, then we can have more powerful conclusions and make recommendations,” Dr. Selting said. “And sometimes it’s hard to find those cases. We know they’re out there. We know that dogs get a particular kind of tumor or cats get a particular kind of tumor. But either the owners aren’t aware of the opportunity to participate in a clinical trial, or they have some trepidation or uncertainty about participating in a trial, or they don’t understand what all is involved in that with regards to money and time.”
The purpose of the cancer trials website was to help researchers connect with cases and to help veterinarians understand what trials were available while offering options and sometimes cost offsets for animal owners.
“People will enroll in clinical trials for any one or a combination of these reasons: One is that they are seeking novel therapy because everything else has failed, and their pet still feels OK, and they want to keep trying. Two, they need subsidized care,” Dr. Selting said. “Some people just really want to contribute to the greater good. I have people that come in, and they know there are other treatment options, and cost really isn’t a particular constraint or concern for them, but they really feel good about contributing to the big picture.”
Dr. Selting believes the new AVMA database will be helpful for practitioners. Having been in private practice, she knows that a practitioner might have 15 minutes for an appointment. So the practitioner offers options A, B, and C to the client. Now the practitioner can offer options A, B, C, and D, with D being to look for a clinical trial.
Another potential benefit of the AVMA database is completing studies more quickly.
Dr. Selting added that the working group tried to be inclusive so that the database includes every aspect of veterinary medicine, even wildlife studies that are not clinical trials but do involve and benefit animal health.
Dr. Theresa “Terry” Fossum is chair of the AVMA working group, vice president for research and strategic initiatives at Midwestern University, and a professor of surgery at Midwestern’s College of Veterinary Medicine in Glendale, Arizona.
“Clinical trials have long been an interest of mine,” she said. “I am a huge proponent of the use of naturally occurring animal disease.”
Unlike research animals, Dr. Fossum said, pets develop diseases naturally for the same reasons that people do, such as natural genetic variation and environmental factors. She believes enrolling pets in clinical trials will reduce the speed and cost of developing cutting-edge treatments and sophisticated diagnostic procedures for people and pets.
“Increasingly, our clients want the best of care,” Dr. Fossum said. “They expect what they would get if they had that particular disease, and sometimes that does involve enrolling in a clinical trial.”
To find clinical trials, a veterinarian has had to go to multiple websites and might have had no way to see what was available at private practices. “So having one site where it’s easy for veterinarians and for pet owners to go in and see what clinical trials are available is just a huge move forward,” she said.
Like Dr. Selting, Dr. Fossum has noticed the extent to which pet owners will go to treat an animal, often for reasons beyond hope for a successful treatment. She said, “They are going to have other pets, and they want to facilitate research that will reduce diseases; oftentimes, they are going to have a pet of the same breed. And then the other reason they will often state is that they do want to help humans.”
Dr. Fossum said the AVMA database also serves as an educational tool with information about what a clinical trial is, what participation means, and what some of the terminology means.
As studies listed in the database are completed, the working group is hopeful that researchers will return to their listing to post the results of the study—in formats such as a summary, abstract, or manuscript.. Part of the idea is to provide information about whether results are negative or positive, and therefore, whether an intervention is worth pursuing. Dr. Fossum said, “Very few people publish negative results on the whole, but sometimes those negative results are as informative as positive ones.”
Submitting and finding studies
Investigators who want to call for study participants via the AVMA database should submit studies through the website. Members of the AVMA can log in with their identification number and password, and others can create a user account. A dashboard page allows investigators to add or edit studies.
After an investigator submits a study, AVMA staff will scan it and forward it to a curator. The curator will help the investigator clarify information as necessary, then will mark the study for publication on the website.
Visitors to the website can view all available studies or search in the following categories: diagnosis or keywords, primary field of veterinary medicine, country, and species. Details about the studies include a project description, study type, intervention, inclusion criteria, exclusion criteria, potential medical benefits to enrolled animals, potential medical risks to enrolled animals, and financial incentives for study participants.
The AVMA Animal Health Studies Database is at www.avma.org/FindVetStudies.
Related JAVMA content:
AVMA board laying groundwork for future endeavors (March 1, 2015)
Registry for veterinary clinical trials being considered (June 1, 2014)