You might be thinking, “Yea right. I’m not going to be the first.” Just the term “guinea pig” gives most people negative vibes. But have you ever struggled with a health condition and tried several prescription treatments, but they didn’t work? Or maybe they worked a little but didn’t control your symptoms or improve your quality of life? Maybe you are on a prescription medication that works like a dream. Ever wonder how those prescription medications came to be available? Well, they were studied in a clinical trial with patients who decided being the first or a “guinea pig.”. Now you probably want to stop reading but don’t! Trust me! While clinical trials don’t seem like a spicy topic, they are the foundation of getting new indications or new medications to patients. Even you Botox lovers out there—read on! How do you think your Botox got approved for wrinkles in the first place?
Think of clinical trials like a test drive for prescription medications, surgical procedures and devices. Clinical trials might study a new medication or one that is already approved by the FDA, but it’s being looked at for another indication. Clinical trials look at the drug’s chemical properties, safety and efficacy, which refers to how well it works. Before a medication is approved by the Food and Drug Administration (FDA), it goes through extensive testing and the information gathered during that time is used to help decide how much medication you should get, how often you should get it, what side effects might occur and if there is a need for blood tests or other monitoring.
So why participate in a clinical trial you ask? Maybe you want to contribute to making new treatments available. Perhaps your condition has not improved with available therapies, and you want access to the latest treatments. Clinical trials only exist because of patients, like yourself, who decide to participate. Yes, what you might call a “guinea pig.” I challenge you to not be afraid of being the first or a “guinea pig.” Clinical trials are performed with patient safety as the primary focus. A clinical trial can only move forward when the study is reviewed and approved by an institutional review board (IRB). The IRB has a thorough process to ensure that studies are performed ethically and have safety measures in place. Before you would agree to be a participant, you would complete an informed consent form (ICF). The ICF highlights all the information you need to understand the risks, benefits and alternatives of being in a clinical trial. It’s always your choice to say yes or no.
Trotter’s Take: Clinical trials aren’t for everyone but think of all the patients before you that volunteered so that you could have that prescription cream you love for your acne or eczema. Overall, clinical trials provide hope for many patients and help us discover new ways of treating disease.
Want to learn more? Tune into my podcast with Dr. Rocco Serrao, who has led several clinical trials.
