My Experiences with Clinical Trials •
By Sean Baumstark •
I had the opportunity to visit the University of Minnesota three months before their city was hosting the NFL’s 52nd Super Bowl. Even three months out, the buzz in that city was almost tangible. While chatting with my Uber driver, the Super Bowl became a topic and he had mentioned that some companies, such as telecom giants, had groups of employees coming and going for at least six months prior to even my visit! As I’m sure you can imagine, the details that go into planning such events seem endless when you start to think about it all.
How Many Moving Parts are there in Clinical Trials?!
While clinical trials may not generate as much buzz as Super Bowls, they certainly have their own list of endless details to conquer. Recently, while participating in a clinical trial at my ‘home’ clinic of UCLA, I started thinking about all the moving parts that were at work behind the scenes, and the many months of planning just to have me sitting in that doctor’s office. Just getting a drug ready for trial takes years, and hundreds of millions of dollars. Fast forward to trial initiation; one study shows that it takes an average of 8 months for a drug to go from trial approval to dosing its first patient. But before I can take my first dose as a participant, a study site has to be approved, a coordinator must be employed and trained, a packaging and shipping plan for the drug itself must be developed, someone has to schedule my visit,, help arrange my travel and schedule accordingly, someone else has to pay for all these things as we go…he list goes on. I haven’t even touched on the communication needed between every single person involved. It’s easy to think it’s simple; someone calls me, I get on a plane, a car drives me to the site, I sit down, blood is drawn and then I’m driven back to the airport to catch a return flight. Usually and thankfully, it feels that simple.
Wait, Clinical Trials Require How Much Logistics?
Behind it all, there is a massive crew of people, each playing a vital role in the process to help take a drug from concept to cure. How will the drug be packaged? How will it be shipped? Does the temperature during storage and shipping need to be regulated? Will the package design that the developers came up withstand the shipping? Will the finance team agree with the scientific team? Will the patient be able to open the bottle?
A huge portion of this crew may never be known or recognized; their job is done with devotion from a cubicle as they hope their work makes a difference.
It does. It makes all the difference.
Clinical Trials Bring Positive Life Changes
One trial that I participated in allowed me to experience a couple amazing improvements! Fatigue is a serious symptom of my condition, yet while in this particular trial I felt more rested every morning and I was able to engage in more activities throughout the day! Also, my speech had improved and several people around me made the observation that I was easier to understand! Clinical trials are life changing and always lead to necessary answers. Even in failure, something is learned! Positive results are always encouraging and remind me of the importance of the trial process and of the dedication and the diligence behind every drug.
As a rare disease patient and as someone who is committed to participating in any trial I’m eligible for, I’m incredibly grateful for the folks who work tirelessly to ensure every detail is considered and settled long before I’m putting my life or my condition at further risk. The more I think about the details behind the process, the more I understand why drugs typically take 10-15 years to get to market and the cost to do so reaches over $1.3 billion. The disease I live with, Friedreich’s Ataxia, is life-shortening. So, yes, I’m in a hurry. But shortcuts are not worth the risk. Money will never expire, but life and time will.
If you’re a part of the process – thank you for being diligent, on my behalf, no matter the cost!
This post originally written for Sherpa Clinical Packaging, Jun 2018. Visit their Clinical Supply Blog here.
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