Gaga over clinical research?

Lady Gaga may have been born that way, but a good investigator is not.

It takes a special breed of veterinarian to be a good investigator, and not all veterinarians make the grade. But, for those who do, the rewards are substantial, both personally and professionally. So, what makes a good investigator? After more than eleven years of managing veterinary clinical trials (and more than twenty on the human side), I think I know.

An interest in science might help. A drive for perfection can be a plus. A desire to offer alternative therapies to patients for whom all other treatments have failed often provides the motivation. However, the key ingredients are an understanding of the purpose of clinical research coupled with the ability to follow instructions (i.e. the protocol) exactly. In fact, I’ve found that the best education, years of practical experience and strong patient dedication are not enough for investigators who don’t also possess the keys to clinical trial success.

For example, we once had an investigator who “experimented” with the study’s dosing regimen in an attempt to accelerate or enhance results. Another calibrated their clinic scale with bags of dog food (which I’ve heard can vary by as much as 3% from the weight stated on the front of the bag). And then there are those for whom initials and signatures are interchangeable.

One of our better investigators now didn’t start out that way. In fact, his first study almost ended his research career when it had barely begun. This seasoned veterinarian was quite enthusiastic during protocol training and returned home eager to start enrolling. His numbers out of the gate were impressive. Unfortunately, his data forms were not. After our first monitoring visit, he called me and said, “I don’t think I’m cut out for this. I’m a perfectionist, but now I’m being told that my work is not perfect. In fact, I just received a 4-page error report. Please close my site.” Having been down this road before, I instead suggested that we review his error report together. As we went through the report, I offered various ways that he could improve his performance. I then requested that he persevere and call me in a couple of weeks. He agreed to give it another try.

Two weeks later, he called to tell me that he had changed his mind about quitting the study and that he now understood how to complete the data forms correctly. “I haven’t received a single error report,” he proudly noted. “What’s more, being a study investigator has made me a better veterinarian! Thank you.”

Whenever I see an investigator finally “get it,” it warms my heart. It makes up for the veterinarians who do clinical trials just for the money, or as an interesting break from itchy skin, diarrhea, and hair balls… and even for the ones who get involved so they can offer promising therapies to their patients with persistent problems, but who don’t really understand their role in the clinical trials process.

The good ones understand that the clinical trial is testing the hypothesis outlined in the protocol, and that their role is to follow that protocol exactly. They know that good data matter and can determine whether the new therapy ultimately gets approved for general use. That’s why they strive to be as complete and accurate as possible. They ask for clarification of anything that’s confusing or contradictory. They correct any inadvertent errors willingly and quickly.

The byproduct of this enlightened effort, of course, is that these investigators become better at everything they do in their regular veterinary work. Plus, when the test article is effective, they get the emotional high of returning a healthy pet to a grateful owner. As one investigator put it, “You can’t imagine the excitement we feel when we see the product work. The look on the owner’s face is priceless!”