Almost 90% of all clinical trials experience significant delays. There are four main causes of study delay (please see Animal Pharm 690, p 11) but, by far, the most significant is slow enrollment. Sometimes, enrollment lags because the investigator forgets about (or loses interest in) the study. Sometimes, the investigator overestimated his/her available population of potential study subjects. Other times, the study’s inclusion/ exclusion criteria present formidable challenges to successful enrollment.
Even when the investigator is enthusiastic about the study and actively recruits, their results may be disappointing. Part of the problem with any recruitment scenario is the direction of the communication. In most instances, the investigator is reaching out to pet owners to inform them of the study in the hope of recruiting them to participate. These solicitations often are unsuccessful because the pet owner does not fully understand the benefits of the study, is afraid of real or perceived risks, or views study participation as an unwelcome inconvenience. How might we change the dynamics of study subject recruitment to minimize these obstacles and boost enrollment?
I think about that question a lot and have experimented with a number of different approaches. One of my first steps was to try to understand the clinical trial process from the perspective of a typical pet owner. Therefore, at the conclusion of a recent multisite, double-blinded trial, we asked all of the ownerparticipants what drove their decision to participate in the study. A little less than a third responded. I’m sure that there is something interesting in that percentage, but pursuing that path would have distracted me from the valuable information that the 77 responders gave me.
Desire to improve their pet’s health: 63
Payment for participating: 8
Advance veterinary medicine: 4
Alternative to euthanasia: 2
More than 80% of these participants wanted a way to improve their pet’s health and quality of life. Just 10% did it for the money, and only about 5% expressed an altruistic motive. For me, one of the most inspiring statistics was that this clinical trial saved the lives of two pets.
Admittedly, this is a rather meager sampling, but it does suggest several steps we might take to facilitate study subject recruitment. First, those pet owners who are more pro-active and regular in scheduling their pet’s care may be more likely candidates for study participation. Also, cost-conscious pet owners who are dedicated to their pet’s well-being may become eager participants when told that their pet’s treatment will be free or (even more enticing) compensated.
Some readers might use this limited data to reinforce their feeling that owner honoraria are an expensive and unnecessary recruiting tool. Our experience in the field does not support that view. However, we also have learned that most potential study participants who are principally interested in the free treatment for their pet and compensation for themselves will not be protocol compliant. No matter how anxious you may be to enroll subjects to meet your study’s timeline, you will not be doing yourself any favors by enrolling such owners.
While all of this information is interesting, and may be helpful, it does little to overcome what could be the biggest obstacle to rapid enrollment. Many pet owners are unaware that clinical trials even exist. They are thrilled to learn that their pet could have access to otherwise unavailable leading-edge therapeutics to treat persistent, chronic, or previously untreatable conditions. They also are grateful for the free examinations and laboratory tests, as well as the compensation they might receive for transporting their pet to and from the participating clinic and completing study activities at home.
If more pet owners knew that clinical trials were a viable treatment option for certain situations, they would begin to request that their veterinarian participate in more studies. Perhaps it’s time for an industry-wide advertising campaign to educate the pet-owning public about the personal benefits and societal rewards of clinical trial participation. Maybe it’s time to add more courses in clinical research to the curricula at all of the veterinary schools and continuing education courses in clinical research included in the programs of the major veterinary conferences. Steps like these will change the direction of clinical trial communication and build more grass roots demand for clinical trial opportunities. That, in turn, will make recruitment for your next study that much easier.
In my next article, I’ll share pet owners’ perceptions of the effectiveness of study participation in alleviating their pets’ symptoms.