What you don’t know about clinical trials may hurt your pet

Tuesday, Mar 25th, 2014 | By Dr. Marty Becker

If you had a pet with a life-threatening disease that had no reliable cure, would you consider being part of a clinical trial for a new treatment?

Your answer to that will probably depend on how much you know about clinical trials. I discovered not every knows what they are when I shared news about a trial for canine osteosarcoma — bone cancer — on my Facebook page, and a large number of readers objected to such trials because they wouldn’t want their pets to be “experimented on in laboratories” or to be denied pain medication or other, possibly helpful, treatments, in the name of research.

As a veterinarian who has shared information about available clinical trials with many clients, I was surprised that there was so much confusion about what these trials are like. In my experience, pet owners are eager to get into them, hoping against hope there will be something that will help a pet otherwise facing poor or hopeless odds.

PageI turned to Dr. Rodney Page, director of the Flint Animal Cancer Center at Colorado State University, to help explain what treatment trials are like, so pet owners can make informed decisions about them for their own animals.

Here are my questions and his answers:

1. Dr. Page, can you briefly explain canine osteosarcoma, and why new treatments are so important to helping affected dogs?

Canine osteosarcoma is an aggressive tumor that arises from a bone. By the time the owner or the veterinarian knows something is wrong with the dog, it has almost always already spread.

Over 90 percent of dogs with this disease will die from it as there is currently no cure. The majority of dogs die within two years of the diagnosis, half of them even before one year in spite of aggressive treatments such as amputation and chemotherapy. Given such a poor prognosis, newer treatments are necessary to change and improve the outcome of these dogs.

New treatments for dogs that have extended survival time and increased quality of life include new chemotherapeutic and  immunotherapeutic agents, as well as a surgical procedure to maintain limb function and radiation treatments that substantially reduce the need for an amputation.  Several of these new treatment options have also become common for the treatment of childhood osteosarcoma.

2. Can you describe treatment trials for osteosarcoma, explaining to my readers why this is not the same as “experimenting on dogs in a laboratory”?

Clinical studies are essential to find new treatments, diagnostic tests, devices, vaccines and prevention strategies. Every current therapeutic agent (antibiotics, pain medication, cancer therapy) has to be studied and approved by the FDA or USDA in order to be used in veterinary species.

A very important fact to remember is that dogs in clinical trials develop the disease spontaneously. Unlike laboratory animals where the disease is typically induced for the purpose of the experiments, dogs in trials have the disease occur naturally and owners with dogs that have a type of cancer for which there are currently few effective treatment options or initial treatments have failed may choose to enroll in studies.

Owners are always given all of their choices before a dog is enrolled in a clinical trial and have all of the benefits and any unknowns thoroughly explained. The decision to enroll a dog in a clinical trial is the owner’s decision.

Pain control is always a component of a clinical trial. Often, dogs in clinical trials will receive the standard of care, just like they would if they were not in a clinical trial, and then they receive the investigational treatment which is believed to offer additional benefits.

Owners always have the option to opt out of the clinical trial for any reason, and will always be managed with the best options available off-study. Dogs in clinical trials are very carefully monitored and each trial must be approved by an independent committee to insure the highest animal welfare standards are met.

Frequent review and oversight of the trial is also conducted for quality medical management of enrolled patients. Almost every clinical study in companion animals provides a financial subsidy to cover the cost of treatment and its related expenses, and often helps to cover additional costs of treatment after the study.

3. Can you describe what kinds of benefits to animals have come out of treatment trials like these?

Improved survival of dogs with osteosarcoma has resulted from studies evaluating new chemotherapy options; amputation can be avoided in many instances because of studies to treat the primary region of the tumor in a bone with radiation or surgery.  There are new ways to predict the success of treatment due to studies that identify favorable indications for treatment and new pain medications have been developed to specifically control tumor-related pain.

4. Can you describe the benefits to humans that have come out of, or may come out of, trials like these?

Some diseases in dog are extremely similar to the same diseases in people. There are more clinical studies being conducted in dogs and cats for diseases other than cancer than there are for cancer.

Osteosarcoma is a great example of a disease that occurs in kids and dogs with similar biology and clinical progression. Because of this, it is very likely that what we learn in dogs will be applicable to humans. The treatments (surgery, chemotherapy and immunotherapy) listed above are examples of several advances in kids with osteosarcoma that have been developed in dogs with osteosarcoma.

5. Is there anything I didn’t ask that you’d like to share?

Clinical trials in companion animals are required for every new product to be thoroughly studied for effectiveness.  Treatments that are used currently have been studied in the past for vaccines, antibiotics, hormone therapies as well as cancer treatments through approved trials with trials conducted in both in private veterinary practices as well as academic centers.

The future of animal health depends on well done clinical trials for every disease that affects companion animals.

Thanks, Dr. Page, for contributing to pet owners’ understanding of this important issue!

Readers, based on what you’ve seen here, would you ever consider enrolling your pet in a clinical trial?