Why do we call things “investigational products” in research? That sounds so scary.
I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. In research, it’s in the important consent document; it’s in the language that we use when we’re talking with patients about research. We call the research stuff “investigational products” and that sounds scary. So why do we do it? Well, we do it because we have to – because that’s the law.
A drug or a vaccine – medical stuff that’s already been approved by the FDA in the US or some other regulatory body. A drug is a compound that has a therapeutic effect. It’s already been proven. A drug is a substance that is going to have a physiologic effect on your body – a positive effect, a therapeutic effect. And the entire point of research is to figure out if there is an effect and how much of an effect there is. Is the effect worthwhile? Is it big enough? And that’s why in research, we’re not allowed to call what we’re researching a drug.
We’re not allowed to call it a drug. We’re not allowed to call it a vaccine. We have to come up with a different name for it, hence “investigational product”. It’s not really that scary because the reality is we’re not allowed to do research unless everyone feels that there is a really good chance that this thing is a drug, a medicine, or a vaccine. That’s entirely why we’re allowed to proceed in the first place. But until we’ve proven it or disproven it, we have to call it an “investigational product”.
And that’s why! Thank you for riding along with me. Take care!
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Have you ever wondered why researchers use the phrase “investigational product” instead of referring to what they’re researching as a drug or vaccine? Ride along with Dr. Jeff Kingsley and find out!
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