Troubleshooting When Participating In A Clinical Trial
I consider myself fairly seasoned at participating in clinical trials for my asthma. However, it is important to remember that, just like in life, things happen in studies too. I recently had one of those experiences.
Safety measures in clinical trials
Studies have an amazing amount of safety protocols in place, almost excessively so. In my experience, studies record just about everything: history, personal information, symptoms, other medical information, etc. Information is kept extremely confidential; they often use unique numbers (study numbers) to identify you, versus your name or likeness ever being conducted. Your data is kept extremely secure, including high-level information such as the date when the files would be destroyed.
In my experience, clinical trial safety measures carry forward to when a problem may be encountered with an investigational drug that you take at home. This is what happened to me recently.
Encountering a safety concern
I am currently in a study. I went to take the pre-filled syringe out of the fridge. It needs to warm up for 30 minutes before it is injected. I usually do a visual inspection to ensure that nothing is floating in the solution and everything looks safe. Upon visual inspection, I noticed that the needle was bent.
If anything happens in this I have access to a study coordinator 24 hours a day via a special telephone number. I usually tackle this injection in the evening--and it was fairly late--but I had no choice but to call. I was able to connect with the study coordinator who was able to advise on the next steps.
Documenting and making adjustments
Clinical trials use a special protocol and guidance from the study sponsor, the regulatory bodies, government, and hospital, who all have several binders worth of safety protocols that are implemented into every study. I had to send the documentation that initially consisted of photos from various angles of the bent needle and a timeline of what I did from the moment it came out of the fridge and box up until I contacted my study coordinator. There is no shortage of documentation in a study.
I then waited to hear back from the sponsor/pharmaceutical company. They advised that I needed to discard the syringe into my sharp bins and use a different kit. There is no shortage of safety in this clinical trial, even though it did somewhat break my heart to discard not only the syringe with the bent needle but also an additional one, as they come in pairs in the kit. I know that this is for my safety, but considering how much they cost and how wasteful it seemed, it felt like such a shame.
There was good news on the horizon! I was given the authorization to take an alternate kit. I will be bringing the discarded syringes that will be sent off for further inspection and determine how they were bent. I am impressed that they are looking into it. While I have no proof, but if I had to suspect, it seems like a miss in the manufacturing process of the syringe. I am not sure if they will ever tell me what may have bent the needle, although I am very curious to know why.
Have you considered being in a clinical trial or study for your asthma? Have you been concerned about safety? I would love to hear about your experiences or your fears.
Are you currently taking Breo Ellipta?