Patients Always Ask
Hello and welcome to another edition of Riding in Cars With Researchers. I’m Dr. Jeff Kingsley and today I’m going to answer a question that I frequently get from patients….”if the study drug works for me, can I continue to take it at the end of the trial?”
Unfortunately, usually, no. Why? The point of research is to have a systemized process whereby we can look at the safety and efficacy of something stepwise, where piece by piece we learn more about the safety and the efficacy of something. That’s why the whole thing exists and that’s why we can’t just simply give experimental compounds to people without regulatory bodies like FDA, EMA, and Health Canada looking at, vetting, and approving our ability to move forward. The process is slow, but it exists for a reason. It exists to protect you and that’s a good thing. The downside is if you got benefit in a research trial, you can’t simply stay on the compound that we used.
Open-Label Extensions
What are the exceptions to that? There are many protocol designs that have what are called “open label extensions”. I have one going on right now in ADHD, where kids entered that trial and for the first 12 weeks they were in a randomized placebo-controlled portion of the trial. After those first three months they went into an open-label extension, meaning now I know that they are on the study drug, I know precisely the dose of the study drug and I can increase their dose or decrease their dose. There’s no randomization and they can stay on the drug for several years. So there’s an example where if it was working for you, now you can enter an open-label extension and get several years worth of that medication for free, along with free healthcare from me. They still get all those benefits of the research experience. I really enjoy those trials that have open-label extensions. It’s a wonderful extra benefit for the patients, so look for trials like that.
The Process Protects You
The reality is many times trials aren’t running one at a time, but rather there are multiple research protocols going on simultaneously. There are times where we’re in the midst of one research protocol on a compound, and it gets FDA approval while we’re doing the research. And so there’s an example where at the end of a trial, you could actually get a prescription and get that compound because at that point it’s, it’s officially called a drug. So the process is there to protect you. That’s why at the end of a trial, most often you have to come off of the study drug. Look for open-label extension trials and sometimes the drug gets FDA approval while you’re in the trial. So there’s the full rationale. I hope that helps.
Thanks for riding along!
Send me topics you want me to talk about at jeff.kingsley@centricityresearch.com!
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