Patients today seem to know a lot more about clinical trials than when I started my career in the mid-1980s. Phrases that used to require a lot of patient education, such as double blind or informed consent document or placebo, are often already understood by the patient volunteers. This newfound patient knowledge is a good thing for which I’m happy to take some of the credit – LOL!
So let’s talk about placebos (just in case you don’t know, a placebo is a copycat inactive treatment that looks exactly like the active treatment). Although patients often know what a placebo is, they underestimate the value of the placebo-treated patient volunteers.
Why are placebo-treated patients so important? I’ll try to explain this using the analogy of filling up your car’s gas tank. Let’s say you want to track the gas mileage you’re getting in your car for the next year and you plan to put in $20 of gas every Sunday. Will you be able to calculate your gas mileage? Nope, not without knowing exactly how much gas is in the tank (your baseline) when you add gas each Sunday. In the same way, we need to have the baseline patients – the placebo-treated patients – participate in the entire study in order to understand the impact of the active treatment.
Does this mean patients in the placebo arm aren’t getting any treatment for their condition? No, not at all because in many cases that would be unethical. Studies are designed such that the investigational treatment is in addition to the current standard of care for the medical condition. In other words, every volunteer is receiving the usual treatment and a portion of them might be receiving additional effective treatment.
Full Disclosure: Sometimes there is no usual treatment; the standard of care is to monitor and observe. When this is the case, we still feel that a research study is a good option because volunteers in a study typically receive closer monitoring than is the norm.
Also – and this is important – studies with a placebo treatment have a plan in place for a volunteer who may or may not be receiving active treatment but who the study doctor feels is sub-optimally treated. In other words, no matter which treatment patients receive in a study, there is a plan in place to provide additional treatment should it be necessary.
The Clinical Research Center is currently seeking volunteer participants in studies for Alzheimer’s disease, Type 2 diabetes and a vaccine to prevent exacerbation in people with chronic obstructive pulmonary disease (COPD). Click here if you’d like to be contacted about one of these studies.
If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163 or send an email to firstname.lastname@example.org. Or, follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.
– Julie Carrico is Associate Coordinator of The Corvallis Clinic Clinical Research Center and a Certified Clinical Research Coordinator.