Be Query Wary…or Query Weary…Your Choice

At the end of the study’s protocol training, everyone agreed that the meeting had been very successful. Most of the sessions were quite interactive, lively in fact, and all of the attendees were eager to get started.

Charles, the study’s project leader, decided that whatever his team had done to generate such enthusiasm, they should do exactly the same things for every training meeting. As he boarded his return flight, he felt confident that the study would go very smoothly.

In many ways, it did. Within two weeks of training, site initiation visits had been completed at fifteen private­practice and academic hospitals. Six weeks later, half of the required 200 dogs had been enrolled.

Eight weeks after that, the last subject completed its last study visit. Charles was very pleased. He even joked with some of the investigators that their pace had forced him to work harder to keep up.

Since Charles had decided to use electronic data capture for this study, he and his team could review data in real-time and issue queries to the investigators very quickly. However, due to the rapid pace of enrollment, no one on the project team paid much attention to how many queries were being issued.

At the end of the study, they were shocked by the total number of queries which, depending on the site, ranged from six to thirty-eight per subject! Why? And, even more curious to Charles, why did some sites average six while others had thirty-eight?

Charles’ first call was to Dr. Bradley, the best performing investigator. “Of all the investigators, you had the fewest queries, averaging just six per subject. Since everyone attended the same training, why did you do better than many of the other investigators?”

“I’ll let you in on my secret,” she laughed. “I used to want to be the first and fastest to enroll, but I made a lot of mistakes. The first cases uncover all of the problems, so whoever has those is the study’s “guinea pig.” Now, I screen potential subjects as fast as I can, but I don’t schedule the first study visits for a couple of weeks. After most of the glitches in the protocol or EDC system have been fixed, I’m off and running. So, I learn from everyone else’s mistakes and make very few of my own.” Charles thought for a moment. “So, if each investigator completed a “trial” subject to work out the bugs, would everyone make fewer mistakes?” “Well,” Dr. Bradley sighed, ”You’ll never eliminate all of the mistakes, but you will minimize them. Maybe you should try this in your next study.”

Charles then called Dr. Davidson, who averaged only seven queries per subject. His secret? A traffic cop. ”When I realized how much my practice enjoyed doing clinical trials, I designated one of our technicians to be the study coordinator. That person directs all of the study activities, ensuring that everyone completes everything completely, correctly, and on time.

“They review all of the data before I do and then make sure that I sign and date forms according to the protocol.” He chuckled and said, “They keep me on a pretty short leash!”

After several more calls, Charles contacted the investigator with the highest number of queries. Dr. Pinkman was not too eager to discuss his performance. “I guess I relied too much on my lead technician. He’s done such a great job in the past that I didn’t pay very close attention during training. A week after the meeting, my technician had emergency surgery to remove his appendix.

“Then, on his way out of the hospital, he tripped and broke his ankle. So, I was really on my own with this study because no one else had been trained. And, unfortunately, I wasn’t all that clear on what I was supposed to do.”

Given the high number of queries at some of the other sites, Charles suspected that Dr. Pinkman was probably not the only investigator who was unclear about study responsibilities. Charles asked Dr. Pinkman to think back to the training meeting and asked him, “If you were starting this study again, what would you have done differently? Better yet, what should we have done differently?” Dr. Pinkman didn’t hesitate to offer a suggestion similar to Dr. Bradley’s.

“If you had taken us through a complete case, from screening to enrollment to last visit, I think I would have had a better grasp of what to do and not made so many mistakes. I just hope you’ll give me another chance to show that I can do things right.”

After hanging up the phone, Charles realized that he now had a more thorough understanding of what he and his team needed to do, both at future training meetings and during future studies to help all investigators produce better results.