Clinical research trials are designed to be perfect experiments where everything including breakfast, swallowing the pill, blood pressure checks, and blood draws are carefully planned. Timing is set to occur at exact time points. This allows for consistent and meaningful data which will (hopefully) inform researchers on everything from how the drug is absorbed into the blood stream to how quickly it is metabolized. Safety, of course, is of the utmost importance. Study participants are therefore monitored carefully for untoward events. Everything is recorded and timing is noted to the exact second (using satellite synchronized clocks.)
My business trip to Nebraska was more of a formality than anything else. Staff at the clinical site performing our study are experts on this stuff. It is their bread & butter so to speak. For this reason, I was quite nervous about presenting to them. You could say that I planned for the worst but hoped for the best. Because of this bread & butter expertise, they were well versed in the drill. I couldn’t help but be nervous anyway and waking up 30 minutes before leaving for the site (thanks to human error on alarm setting) did not help matters.
I began my presentation informing them that I was going give them a brief overview of the study drug characteristics and product history. Then, I kicked it off with “as you may know…” I was painless and over before I knew it. I tried to make fun of myself saying that I really had to practice saying the mouthful of big technical words that came on the 3rd slide. When the questions came flying in my direction, I was pleased to have answers to provide. I even was able to answer the study physician’s question about the excipients contained in the drug product.
The presentations were followed with a trip to the pharmacy where I watched the study treatments being carefully packaged up to meet protocol-specified requirements for a random distribution of treatments across study participants. Again, a bread & butter expertise was displayed as three pharmacists counted, double-checked, and triple-checked as the pills were placed in little carefully labeled baggies.
The formalities then continued in the next building where documentation was checked over to further verify compliance with regulatory requirements. Everything was in order as expected.
It was mid-day when I left for the airport with confidence that everything has been set in place for a perfectly-executed trial. This doesn’t mean that there won’t be problems. It just means that we did our job in preparing every aspect we could.
Like in marathoning, where training plans are followed carefully from diet to workouts to tapering, the outcome will not be realized until the gun fires. We attempt to control everything, but we can’t — no matter how bread & butter our approach has been.
Still, we hope it all turns out perfectly. That is certainly what I am shooting for.