How do clinical trials work? Dr. Seth Pollack, a clinical researcher, defines clinical trials and explains what occurs in each of the phases.
Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.
Let’s start with a basic question, Dr. Pollack. What is a clinical trial?
Dr. Seth Pollack:
Yeah. It’s a basic question, but actually, sometimes, it can be harder to answer than you might think.
I think everybody has an idea in their mind about what a clinical trial is, you’re going to test a new approach. But actually, there’s a whole variety of different things that can be a clinical trial, right? A clinical trial a lot of the times is testing a new drug, could be testing something for the very first time, could be testing something in combination with other drugs for the very first time. It could be testing a standard approach but doing it in a new way. It could even be giving less treatments than we usually do. For example, if there’s a very intense, harsh, standard of care treatment we might even have a clinical trial where we try a little bit less and see that patients do just as well. So, all of those things are clinical trials, but really the clinical trial in its heart is a very organized and careful approach to testing a new treatment strategy for patients.
Okay. What are the phases of a clinical trial?
Dr. Seth Pollack:
Yup. So, the Phase I clinical trial is usually when we’re testing something for the first time in however we’re doing it. So, it could be the first time we’re testing a new drug, or the first time we’re testing a drug in combination with other drugs. And the real thing about a Phase I trial is that the main goal of the trial is to look at the safety and tolerability of the regiment. That doesn’t mean that we’re not really trying to figure out if the regiment works, I mean, that’s also one of the most important things. But the most important thing for a Phase I trial is making sure that it’s safe and tolerable. A Phase II trial is where we, sort of, shift and we’re still making sure, and double checking, that the drug is, but now our main focus becomes on the efficacy of the strategy.
So, now we’re trying to really figure out if this is a strategy that seems affective enough to go to a Phase III. And a Phase III is a big multi-center trial. Frequently those will be placebo controlled where a lot of the times there’ll be randomized trial where we really try to absolutely prove, beyond a shadow of a doubt, that, that strategy is affective. And those are most of the types of trials that patients will encounter.
Okay. Thank you for providing clarity around the phases.