Trials and Errors

The investigator meeting was over and the entire sponsor team, Abigail, Drew, Mike, and Tammy, thought that it had gone very well. To celebrate, they decided to have lunch at a local barbeque joint. The place was packed. When the waitress finally appeared, she brought a pitcher of beer on the house, and apologized for the wait. As everyone placed their order, Mike poured the beer.

“That was the best investigator meeting I can remember,” Drew exclaimed. “It was clear, organized, and interesting.” “And the investigators asked lots of questions and really seemed to enjoy the discussions,” Tammy added. Mike raised his beer and proposed a toast, “To our investigators, and the great job they’re going to do on this study!”

Abigail sipped her beer. “I hope you’re right, Mike.” “What do you mean, Abigail?” Tammy asked. “I agree that our presentations went well, and that the investigators all seemed to absorb the information. However, we spent virtually no time on potential problems…those things that could go wrong. And we all know that some things will go wrong.”

“Like what, for instance?” asked Mike. “We talked about inclusion and exclusion criteria, dosing, adverse events, and drug accountability. What horrible things are you worrying about?”

“Easy, Mike,” Drew interrupted. “Both Abigail and I have lived through some pretty rough situations as study monitors, most of which were totally unexpected. I don’t even know where to begin. Abigail, I bet you could rattle off a few.”

“Oh, dear, there have been so many!” Abigail sighed as she rolled her eyes toward the ceiling. “I remember my first study as a monitor…the test article was a controlled substance. So, the first thing I did when I arrived at each site was to reconcile the drug inventory. At one site, I came up three tablets short. After recounting three times, and getting the same result, I was frantic. To make matters worse, the test article administrator was out sick that day. Since the investigator was with an owner and their pet in an exam room, I spent an anxious ten minutes waiting outside the door. As soon as he came out, I said, ’I need you, right now!’ Alarmed, he followed me to the narcotics room. As soon as I told him my dilemma, he broke into a huge Cheshire cat smile.”

“You needn’t get your pretty little head into a tizzy over this,’ he said in his thick Texas drawl. ’They aren’t lost at all. I put them in my desk drawer and locked ‘em up.’ When I asked him why he had done that, he said, ’I wanted to make darn sure that, if we lost any tablets, we’d have a stash.’ I thanked him and asked that he give me the three missing tablets so I could reconcile the inventory. Needless to say, as soon as I got back to the office, we closed his site.”

Then Tammy jumped in. “That reminds me of a canine emesis study I once monitored. Great topic during lunch, right? Anyway, one of the investigators, someone we had worked with for years, was enrolling like gangbusters. Her data were complete, she answered queries the same day, and her drug counts were always spot-on. And, since her past performance had been so good, her clinic was the very first site we chose to monitor remotely. As soon as she had finished enrolling the last dog in her assigned block, I scheduled a monitoring visit.

You’ll never believe what I discovered.”

Mike laughed and said, “We can hardly wait to hear!”

“She was downright fraudulent. She had asked the owner of almost every enrolled dog to sign two consent forms. Then, after each owner left the clinic, she made up a name for the fictitious second dog, and divided the blood and urine samples between both ‘cases.’ Before my visit, no one was suspicious because she had been such a good enroller in the past. When I asked her why she had lied to us, she said that enrollment was slow at the start of the study and she didn’t want to disappoint us!”

Drew shook his head knowingly. “Some veterinarians just don’t get it. My worst nightmare happened not too long ago and I’m still reeling from it. We were doing an open-label drug study. One would think that the investigators would follow the protocol, especially because they were not masked to treatment assignment. Well, one investigator thought she had a better idea. Instead of instructing the owner to give one tablet every 12 hours per the protocol, she told the owner to give a half-tablet every six hours. She even gave the owner a pill splitter!”

“How’d you find that out?” Mike asked.

“Oh, that was easy,” said Drew. “The owner had noted in his diary that the investigator told him that a half-tablet dose twice as often would work better. He also had recorded half doses every six hours. Without such a fastidious owner, I might not have caught that one!”

At that point, the waitress returned with their meals… and another pitcher of beer. Mike filled everyone’s glasses and then raised his. “I’d like to propose a different toast!” They all laughed and dug into their ribs and corn bread.