Musings from Margaritaville

Henry, drink in hand, settled into his chaise on the beach. Waves lapped the sandy shore and a gentle off-shore breeze tempered the tropical heat. Henry closed his eyes and drifted off, smiling at the thought of seven stress-less, unscheduled days of a badly-needed vacation. As he dozed, vignettes from the last six months scrolled through his mind. Henry’s tranquil visage gradually morphed into a grimace. He awoke with a start, spilling half of his drink. “Too darn fast,” he muttered as he downed what was left of his drink and signaled for the cabana boy to bring him another.

Henry Richardson was a contract monitor for veterinary clinical trials, and he had just finished monitoring four sites of a multi-site pivotal field trial. The pilot study, which had been completed earlier that year, went off without a hitch, although it had taken longer than originally planned. From the start of the pivotal trial, it was clear to Henry that the study’s project manager wanted to make up the lost time.

The project manager had drafted and published the implementation plan with little or no review by other members of the study team. “Why change anything,” she asked, “especially since everything went so smoothly with the pilot study? Anyway, we’ve got a deadline, and we’re going to meet it! Are you on board or not?”

Henry remembered that the pilot study had gone well, so he decided not to argue. The study’s sponsor was pleased with the pace of planning activities and hinted at multiple future studies if this one stayed ahead of schedule.

Since about half of the sites that completed the pilot study had agreed to participate in the pivotal study, the project manager decided to train each site individually during the initiation visit to save the time and expense of a centralized training meeting.

Henry felt that investigators almost always developed a deeper and more consistent understanding of the protocol in a centralized training meeting. He had raised that point with the project manager but was overruled. “It’s a little late to make that change,” said the project manager. “The budget has already been finalized and we can’t go asking for more money before we have even started.” Unfortunately, since Henry had three of the new sites, he struggled with the repercussions of that decision throughout the pivotal study.

The pilot study had been paper-based, and the pivotal trial was designed that way, too. However, at the last minute, the project manager decided to switch to electronic data capture (EDC) because she thought that it would save time. Henry was a big fan of EDC .. .if the system were properly configured and all users were thoroughly trained.

However, Henry had felt that the project leader rushed through the system design and, perhaps as a consequence, there seemed to be updates every couple of weeks as the need for revisions became apparent. These constant changes confused many of the investigators and resulted in numerous errors, most of which were not discovered until each site was closed out. Correcting these errors had kept Henry at several of his sites much longer than he had anticipated, which created all sorts of scheduling problems and angered the project manager.

Henry remembered other problems with enrollment, clinic staff availability, equipment calibration and malfunction, owner compliance, and downloading medical records to the EDC system, all of which could have been prevented had the team taken the time to think things through before the study began.

Through painful experience over the years, Henry had learned that time spent anticipating problems and developing solutions in advance paid big dividends later on. He agreed that timelines were critical, but he also knew that blind urgency was inconsistent with reliable, successful trial management.

Unlike his project manager, Henry was a big believer in checklists. He used them for virtually every activity he performed while monitoring study sites because he knew that they kept things on schedule and ensured that nothing was overlooked. They also allowed Henry to reorder tasks to accommodate tight timelines or scheduling conflicts. Henry was convinced that a planning checklist could have prevented most of the problems that occurred during the pivotal trial. He resolved to make that case with his project manager when he returned to the office … a long and hopefully restful week from now.

“Here’s your drink, señor. I brought you some bar mix as well. Would you like me to reserve you a table on the veranda for dinner this evening?” “Si, Jose, that would be very nice.” Henry took a sip of his drink and turned back toward the sea as the sun began to sink into the horizon. The problems of the recent pivotal trial suddenly seemed far, far away.