MedEvidence! Truth Behind the Data

Phase One Clinical Volunteers Drive Safer Medicines

• Dr. Michael Koren • Episode 371

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Dr. Michael Koren joins Kevin Geddings to explain what "Phase 1" means in the context of clinical research. The doctor talks about how phase 1 is the first time a new investigational treatment is used in a person, but that there is an enormous amount of work that happens before a medication gets to that point. He also discusses the other phases of research, concerns about safety, and why clinical research is so important.

Be a part of advancing science by participating in clinical research.

Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.com

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Music: Storyblocks - Corporate Inspired

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Announcer:

Welcome to the MedEvidence Monday Minute Radio Show, hosted by Kevin Gettings of WSOS Radio and powered by ENCORE Research Group. Each Monday morning, Dr. Michael Koren calls us to bring you the latest medical updates with insightful discussions. MedEvidence is where we help you navigate the real truth behind medical research from both a clinical and research perspective. So sit back, relax, and get ready to learn about the truth behind the data in medicine and healthcare. This is MedEvidence!

Kevin Geddings:

Are you staying warm, Dr. Michael Koren?

Dr. Michael Koren:

I am

Kevin Geddings:

Good.

Dr. Michael Koren:

I was just in uh North Carolina that was even colder than it is here. So it's actually it was actually uh a welcome relief to get warmed up when it came to chilly Jacksonville, Florida.

Kevin Geddings:

Yep, there you go. Dr. Michael Koren is with us, medical doctor, cardiologist, research scientist, a big part of our family here at WSOS, and we appreciate him. Joining us typically on Monday mornings around this time where we talk about a variety of issues, including how you can participate in leading edge clinical research. Today we might talk a little bit more about that in particular and some terms that we hear tossed around that most of us, myself including, don't fully understand, including the different phases of clinical research when a new drug may be hopefully coming to market, right?

Dr. Michael Koren:

Absolutely. So I reviewed an interesting podcast over the weekend, and it was from Marty Makary, who is the current commissioner of the FDA, and he said something that I wasn't previously aware of, which is that there's going to be a push to do more phase one research in the US. And they're going to back that up, the FDA, they're going to back that up by actually providing sort of discounts for pharmaceutical companies that do their phase one work in the US. What what I mean by those discounts is that most of the cost of the FDA is actually paid for by industry, by drug companies and device companies and other healthcare companies that sort of pay to play, if you will. So before they can get a drug approved and go through the process of getting a drug approved, they actually pay a fair sum to the FDA, which covers the cost, uh a big part of the cost, in fact, of looking at whether or not the drug is safe and effective. So with that, there's now going to be this lever to hopefully from the standpoint of the government, get more of the phase one work done in the US, which historically has been done outside of the US. Okay, so what's phase one? Phase one is the first work [in humans] in developing new medical products that's done during the development plan. So when you have a new molecule, you do a lot of work in animals and test tubes and and and now more and more computer analyses of the molecule, and you determine that it's basically reasonable to test in human beings. And then the first phase of research called phase one is when you test these things in human beings. And typically we test these things first in healthy volunteers. And that may only be a couple of dozen patients, or there's actually really not even patients at that point, since they're healthy. And then following that we take patients who are pretty healthy that have the disease that we want to treat. And that would typically involve another maybe 40 to 60 patients. So this type of work is very, very intensive. Phase one work is usually done in a facility where patients are housed so that they can be monitored 24-7. And it's it's a really interesting thing. We've been doing phase one work in Jacksonville for well over ten years now. We have another phase one unit in Inverness, Florida that's been operational for about three years. And people that are part of this come in and they can stay up to three weeks in our facility, try something new, and we assess how it works and is it safe and how they react to it. And it's a it's a really interesting thing. People that do it tend to absolutely love it. It's a very nurturing experience, it's fun, we keep people entertained, but they're also doing something extraordinarily important. They're really truly medical pioneers who move science forward. And for a lot of people, that's really exciting. For a lot of people, especially if they have a genetic condition, they want to feel like they're doing something so their kids and other relatives may not have the same burden that they have with that disease. So we do those studies as we speak. We're doing some really, really interesting phase one work in the lipid space with cholesterol problems, with Lipoprotein(a), and with uh with companies that are on the cutting edge of actually altering genes so that the genetic reason that people have lipid problems are corrected, which is absolutely fascinating and and just a super cool thing. So I'm excited to be part of that. And I think there may be patients that would be very, very excited to be part of that. And the other little thing, uh Kevin, is that because this is early phase work, patients that participate in these things actually get paid reasonably well for their for their time and effort, because it's really, really highly appreciated. So that's another little element of that. We don't like to overly promote that because people should do it for other reasons, but it's not bad. You know, not bad getting a nice little check for your contributions to medical science. So again, as we speak, we're doing multiple phase one studies, but in particular, uh, we're doing really, really cool phase one work in people that have cholesterol and other lipid problems.

Kevin Geddings:

I guess in just hearing what you're talking about, Dr. Koren, uh I mean the average person might say, well, is there additional risk for me to participate in a phase one study as opposed to a study that's farther along or at a different phase?

Dr. Michael Koren:

Yeah, I I would say that the answer to that is probably yes. Again, the the risk is reduced as much as possible by all the work that's done before we uh put a uh anything into a human being. And in many cases, there's already a few patients that have been looked at. But the truth is is that there is a little bit more risk. And on the other s on the other hand, there's there's more potential upside for patients that participated. Now, when we do phase three studies, which are studies that are done after phase one and two, we already have the experience of typically several hundred patients. So we know that the risks are much better understood and usually reduced. But in phase one, we offset those risks, and it's always one by the preclinical stuff that I mentioned, but also by keeping people in-house. So if there is going to be a problem, we identify it immediately and we deal with it. So I would the answer question is yes, there's probably increased risk, but there are many, many, many more measures to offset that risk.

Kevin Geddings:

There you go. Yeah, and it's all part of what you're going to experience that I've personally experienced that very, you know, engaging and aggressive, sort of keeping up with how you're doing as a person during this whole process. Obvious ease of ability to call somebody, you're going to be meeting with people, you know, on a regular, regular basis. There's always somebody around to help walk you through this whole process. So there's really nothing to be that concerned about, correct?

Dr. Michael Koren:

Absolutely. Well, we are the patient's welfare is our number one priority, more so than anything else. So while we all like to contribute to society, there's a cardinal rule in research that the patient's safety and welfare is number one. Numero uno.

Kevin Geddings:

Yeah.

Dr. Michael Koren:

That's we that's what we're most concerned about.

Kevin Geddings:

And before I let you go, of course, every weekend, and especially it seems to come out on Mondays, we always get all these new health studies, Dr. Koren, and this bit of data, and that bit of data, and you know, it comes from everywhere, oftentimes, unfortunately, from TikTok and Instagram.

Dr. Michael Koren:

But I like to say this all the time, and I can't emphasize this enough, Kevin, is when you get medical information on all those less reputable sources that you mentioned, they give you the impression that everything they're saying applies to everyone. And it's just not true. Is that whatever medical information that that we share with people, we always make sure they understand that it has to be applied to the individual. And everybody's individual circumstances are different. So that's a really, really important part of learning about how to use new medical technologies or what to do to protect yourself and your family. Put it in the context of what you are like, what your genetics are, what your situation is, what what what's convenient for you and what's not. So all these things should be considered before you make healthcare choices. We try to provide that information on that MedEvidence.

Kevin Geddings:

Yeah. Dr. Koren, any closing thoughts before we let you go on this Martin Luther King holiday?

Dr. Michael Koren:

No, hopefully uh people get the chance to enjoy the holiday and to uh again take account of their medical situation and always have a plan. We're still early in the year. We talked about New Year's resolutions, and the best New Year's resolution is just to have a plan to address one or two healthcare issues, and that goes a very, very long way.

Kevin Geddings:

That's right. Dr. Koren, thank you. Have a great day. We'll speak soon.

Dr. Michael Koren:

Take care. Bye bye.

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