Not long ago, I read that a colleague had been promoted to director of research at a large pharmaceutical company. So, when I ran into him at a recent industry conference, I was eager to congratulate him. He thanked me for my sentiments, but muttered something about “good news, bad news.” When I asked what he meant, he told me that his management had decided to run a pivotal study using their newly developed project management system.
“Everyone was excited about using this system – me included!” he exclaimed. “Each member of the project team was assigned a role and charged with developing their timeline. All of the individual timelines were emailed to the project leader, who merged them into one project schedule, which he then emailed back to the entire team. The project leader also set up a weekly web cam meeting to review their progress.”
I’ve been a strong proponent of electronic data capture and other technological enhancements to the traditional study management model for some time, so I was pleased to see that another company was joining the faithful. However, I sensed that, in this case, things were not going as planned.
“After several web cam planning meetings, the project leader scheduled our kick-off meeting. On the first day of that meeting, I overheard two team members talking about another team member’s wedding and honeymoon. That’s how I learned that Olivia, the person responsible for selecting study investigators, had left on a month-long vacation. Everyone on the team had known about Olivia’s upcoming wedding but, apparently, no one had connected her pending absence to the study timeline. What were they thinking?”
Before I could ask the obvious question, my colleague continued. “I begged the project leader of another study team for help. She put in many extra hours to assemble the needed study sites. She assured me that each site had been qualified for the protocol and verified for potential enrollment. I felt that we were back on track.”
Having heard similar assurances myself, I knew where this story was headed. Enrollment was slow starting and lagged behind predictions. When pressed for explanations, most of the investigators admitted that they had guessed about their potential enrollment volumes without actually checking their databases.
Then, the team discovered that the central laboratory did not offer one of the critical tests, instead sending it out to another lab. “And that test required dry ice for shipment!” Apparently, no one had caught that detail since no arrangements had been made to supply the sites with dry ice.
I asked my colleague if things were now under control. He said that, after several more “surprises,” he held a “very long” face-to-face meeting with the entire project team (minus Olivia). He walked them through the protocol and data forms. He pushed them to think of every obstacle or mishap that could befall them, and how they would handle it. They reviewed everyone’s responsibilities, eliminated duplication, and filled in the gaps. Each task was assigned an early and late start date.
“The critical path was clearly delineated. Slack time was highlighted to help absorb anything they had overlooked. By the end of that meeting, the team had a comprehensive plan to get the remaining sites up and running and the study moving consistently along a new (albeit extended) timeline.
The icing on the cake, though, came on the evening after this meeting when my colleague returned to his office before heading home. On his desk was a tall pile of unopened mail, which fell onto the floor as he sat down wearily in his chair. He looked down at the letters, papers, and magazines scattered at his feet. There, in the middle of the mess, was a very fancy envelope hand-addressed in calligraphy: a wedding invitation from Olivia!