Announcement:
0:00
Welcome to the MedEvidence podcast. This episode is a rebroadcast from a live MedEvidence! presentation.
Dr. Michael Koren:
0:06
Thank you very much. I appreciate that, so we're going to do something different today. Who in the audience has been to one of our sessions before here in this room? Okay, most people. Who has not? Who's never been here?
Dr. Michael Koren:
0:23
Okay, that's good About.
Dr. Michael Koren:
0:25
Maybe 40% has not. So, for those of you who have not been here, what we usually do is we present a particular area of medicine it's often me or somebody else with another expert and we go through that. So it could be an expert on intestinal diseases, or expert neurologist, or an expert in congestive heart failure, and then that person and myself will have a conversation, with audience input of course. But we decided today to do something different. Instead of talking about an area of medicine, what we're going to do today is just talk about the overall research process, Because in our other talks we always allude to research. In fact, sometimes we go into details about research, and the concept here is this MedE vidence concept that we want everybody to understand information and we want you to understand it from this standpoint.
Dr. Michael Koren:
1:27
In medicine most things in life, but particularly in medicine there are things that we know for sure, there's things that we definitely do not know, and then there's a process to learn about the things that we don't know. So, in a simple case, when somebody comes in to me as a cardiologist and is having a funny pain this, that and the other place I get an EKG and I can tell you if you're having a heart attack immediately, so that I know; but I don't know exactly what's causing your chest pain, and then we figure it out. More broadly, everything in medicine falls into that category. When you come in, whatever your problem is, there's stuff that we know about it, there's stuff that we don't know about it, and there's a process to learn, and one of the most powerful processes that we have to learn is clinical research, and the three heroes here on stage have all been part of that process and they're going to share their stories with you. So I'm actually really excited about the interaction.
Dr. Michael Koren:
2:27
And then the person that makes the heroes heroes is actually sitting right next to me, Nalini Jones, who is truly, I'm truly blessed to have her as our director at our large site on University Boulevard in Jacksonville. Nalini is brilliant, she's caring and she's an incredibly good administrator, so she's actually the manager that runs the show day to day, and so she's going to be here up with me on the stage interacting with our guests and also to answer questions from the standpoint, not of the physician, necessarily, but of the person that's kind of running the day-to-day operations. So that's who everybody is. And why don't we just do this, Nalini just give us 30 seconds on your background and so everybody can hear your voice.
Nalini Jones, BBA, CCRC:
3:14
Sure
Nalini Jones, BBA, CCRC:
3:14
.
Nalini Jones, BBA, CCRC:
3:15
Again. My name is Nalini Jones and I am the site director at the Jacksonville Center for Clinical Research, the University Boulevard location. I've been with ENCORE Research for 26 years now, started as a research assistant.
Dr. Michael Koren:
3:27
She started in utero, by the way, 26 years
Nalini Jones, BBA, CCRC:
3:30
I was born in the parking lot.
Nalini Jones, BBA, CCRC:
3:31
I've been there for a long time, worked my way up to a study coordinator and then to a site manager, and it's been a very rewarding experience for me personally, just because of the blessings that we receive from the participants that come in to work with us. We can go more in-depth later, but you guys have always been a huge part of the success of our organization.
Dr. Michael Koren:
3:57
So, Louise, introduce yourself, so everybody can hear your voice.
Dorothy "Louise" Rohan:
4:00
Hi, I'm Dorothy Louise Rohan and I have been in clinical research for a number of years. I've been with well, I think, as it was already stated, since 2008 with yes, and that is a wonderful staff. I cannot say enough about the employees there. They care for you as though you were their family and I'm just really proud and I feel grateful to be a part of that,
Dr. Michael Koren:
4:29
Thank you, and we'll get into the testimonials in a second,
Dr. Michael Koren:
4:32
but tell everybody where you grew up.
Dorothy "Louise" Rohan:
4:35
Oh, I grew up in a small town in middle Tennessee and I'm a great grandmother and I'm married to the most wonderful man that God ever created.
Dr. Michael Koren:
4:47
Wow Aw, I want to meet that guy. David, you're up.
Dave Gnage:
4:54
My name's Dave Gnage. I grew up in western New York, very close to Niagara Falls.
Dr. Michael Koren:
5:01
Are you still a Buffalo Bills fan?
Dave Gnage:
5:03
Absolutely a Buffalo Bills fan. My uncle took me to the very first Buffalo Bills game.
Dr. Michael Koren:
5:09
Wow
Dave Gnage:
5:10
Well, when they started in 1960. I'm probably the oldest guy on this platform today. I'm married, we have a number of kids and we have a granddaughter who lives with us that we're raising, and she happens to be here today.
Dave Gnage:
5:30
I've been in a number of studies I started with. Well, first of all, I was referred for some studies for heart issues, but I didn't pass the test, which is good because I was better than what they wanted. But then the COVID test came along, so I signed up for that and my wife said well, I can do that too. So I was taking Pfizer and she signed up for Moderna, I think. And my granddaughter said well, if you're doing it, I want to do it.
Dave Gnage:
6:10
So if I could just go back a little bit, when she came with us, I thought she should learn that people give blood for blood tests. So when she was about 10, I took her to when I was having a blood test I said come just see what goes on. Well, when the needle came out, she ran out of the room. But then, when she got interested in the test, I explained that she's going to have blood tests, have blood tests, okay. And she signed up and was accepted. We went in for her first blood test and they numbed her arm a little bit and I held her hand and she was a trooper. Well, she's been through three different research projects and by the time we got to the last one, when it was time for a blood test, she marches into the room, puts her arm down. They ask well, she didn't put her arm down. They ask what arm do you want to use? And she pointed to me and said his,
Dr. Michael Koren:
7:19
That's a good line.
Dr. Michael Koren:
7:21
Thank you for that. So the biggest question for you is your wife, half as good as Louise's husband.
Dave Gnage:
7:31
Louise, she's better.
Dorothy "Louise" Rohan:
7:33
Oh. We must keep them apart.
Dr. Michael Koren:
7:38
And how about you, Tony? Are you married?
Anthony Langhals:
7:40
Yes, I am. As a matter of fact, my name is Tony Langels and my beautiful wife. She's sitting at the table there with the patriotic jacket on. Nice, all right so she accompanied me here tonight today, but anyhow, I'm from Lima, Ohio and spent time with the military, you know, 20 years. But anyhow, I got to say you know I had a long presentation but, Dave, he took a lot of my time here, you know.
Dr. Michael Koren:
8:05
So I kind of have to shorten mine, you know, so that we get out of here. We have plenty of time, but go ahead, just tell us a little bit about your background. Okay, well, like.
Anthony Langhals:
8:13
I say I was in the military aviation with the Navy and also I worked with AT&T Bell South and Vistacon making contact lenses. So you know, know a little bit about that. But anyhow, you know, I went to UNF, graduated there, but I've got to say I'm shocked at the layout here. I've never been here before in the studio here, you know. So you know I'm very impressed with the layout and all the attendance here. So, and also I live on the south side, uh, real close to the uh research center there, uh, Kennerly and University. I could almost walk to it. So, uh, it makes it convenient for me to even get there. So anyhow, uh, you know, I want to thank Dr Koren for inviting me to be up here and looking to have a good time up here.
Dr. Michael Koren:
9:08
Well, thank you very much. That's terrific. So thank you for being on stage, and I'm glad that you all have great spouses. My story with regard to that is my wife and I were happy for 25 years and then we met each other. All right, so people who have been here before know that there's no such thing as a free lunch, and we like to get the audience involved in the question and answers. So we're going to start by this first question.
Dr. Michael Koren:
9:39
By volunteering in a clinical trial, participants play a vital role in A. training robots to become doctors. B keeping the coffee machines running at clinical research sites. C. contributing to scientific progress that could benefit countless others in the future. D. a plausible escape from a nagging spouse. You guys obviously don't have to worry about that one. Or E. proving that laughter is medicine but hard to get approved by the FDA. All right, you guys are good, absolutely. C is the correct answer. All right, you're so good. We'll give you one. More.
Dr. Michael Koren:
10:25
Benefits that patients can reasonably expect while participating in a clinical trial include, A. a lifetime supply of hospital gowns. B. a cure for daytime insomnia. C. free Medications based on essential oils and moonlight. D. inside knowledge, stipends for time and travel and a medical legacy Sounds kind of A MedEvidence t-shirt. If you behave yourself Well, I think we all know that D. is the correct answer. You can get a MedEvidence t-shirt, but you don't really have to behave yourself. All right.
Dr. Michael Koren:
11:09
So with that introduction, I just want to maybe spend 15 minutes giving everybody a little bit of background about how clinical research works, and then we'll get back to the discussion. So there are basically two ways that physicians make decisions. One is called anecdotal and the other one is called evidence-based. And 50 years ago, virtually all medical decisions were based on anecdotes. So a physician would be in a situation and they would recognize the situation and they would say, okay, well, in my experience, this is what works. Or, oh, I tried this for the last five times and it seemed to work, so let's try it again. Or, oh my God, I tried this and it was horrible, so I'm not going to try it again in you, even though some people think it works.
Dr. Michael Koren:
11:56
So it was all based on anecdotes, but we've moved away from that model as much as possible. It still happens, but now we want to do everything based on evidence. And when we say based on evidence, that means these are things that are proven to work in a structured experiment or a structured clinical trial. And under those circumstances we say, okay, a thousand people tried treatment A, a thousand people tried treatment B and treatment A worked better than treatment B. So, doctors around the world, let's use treatment A and that's the concept behind evidence-based medicine. And we apply this to new drug development, to new procedures, to new psychiatric methods.
Dr. Michael Koren:
12:42
This is ways that we do things and there's a whole process to run clinical trials or research in order to get evidence, so physicians and other practitioners around the world can make good decisions based on real information rather than just what they saw over the last year. So this is a huge breakthrough in medicine and this concept is ancient in some ways, but, believe it or not, it's only been structured in its current form since the 1970s and early 80s. So prior to around 1980, it was very, very difficult to do a really well-conducted structured clinical trial. But since 1980, which is less than 50 years ago, we now have this incredible mechanism and trained professionals like Nalini Jones who know how to run these studies, and this has become a phenomenon throughout the US and other parts of the world where we have people that spend their entire career just running clinical trials. Now some doctors get trained in that during medical school, but most really don't. And a subspecialty in medicine are people like me. I practice cardiology. I'm a fully trained cardiologist and internist, but I spent extra time learning how to run clinical trials. So it's a subspecialty in and of itself, where the skill set to run clinical trials is something you apply to your practice and help others do, as we do have done here in Jacksonville.
Dr. Michael Koren:
14:12
Now, evidence-based medicine in its current form evolved from a lot of learning experiences, and we like to call those learning experiences the good, the bad and the ugly, and sometimes research gets a bad name. People say, oh, you're a guinea pig or you're just experimenting on me, and that bad name has sometimes come from things that happened way in the past, but again over the past 50 years. This is now a highly ethical, highly structured, high quality way of not only discovering the truth for society, but always to try to get the best outcomes for our patients. So throughout the process, one of the ethical principles is that we're always advocating for our patients, even if we're not sure what arm of a study that they're in, and we're going to go over some of those details. So let's talk about the good.
Dr. Michael Koren:
15:04
So the concept of comparing two groups is really an ancient one. In fact it goes back to the Bible, and there's a story from the book of Daniel which talks about when Daniel was interfacing with the Babylonians. He noticed that the Babylonians had this really rich diet and he mentioned that. Well, let's compare what happens if you eat the Babylonian diet versus the healthy diet. And lo and behold, Daniel and his disciples ate the healthy diet and they stated, that after 10 years, they felt great that there was a big difference compared to the Babylonian diet. So this is the basic concept of what's called randomization, or comparing two groups, where one group does one thing and the other group does another. Obviously, current trials are much more sophisticated, but this is an example of doing something in a structured way. So it's an early example of what we call the good. Another example of the good is a really interesting project which is considered the first quote modern age clinical trial. It's not really modern because it goes back to 1721.
Dr. Michael Koren:
16:16
But in the 16th and 17th centuries and the 18th century 1721 would be the 18th century smallpox was absolutely devastating. So when smallpox hit a community, up to a third of the people in the community died. Imagine that. So these were devastating things and people didn't know what to do. They weren't sure how to deal with it, they didn't have any good solutions, and it turned out that they knew of what was called inoculation, which is a concept that actually came from Turkey and Africa, where people who got inoculated with the pus of somebody who survived smallpox would be given that in an injection, usually in their leg, and they seemed to be protected against smallpox when it hit the community. So this was considered a crazy idea. Imagine going to a doctor and getting a slash in your leg and then putting pus in your leg. But that was the concept of inoculation.
Dr. Michael Koren:
17:19
So in 1721, everybody knew that there was this smallpox coming to Great Britain. One of the people in the royal family went to the king and said we've got to do something. I'm desperate, let's do this inoculation. Back in those days, of course, the concept was that prisoners didn't have the same rights as everybody else. They went to the prisoners and they took six people and they said okay, this is what we're going to do. We know that this epidemic is coming and we're going to give you this inoculation procedure. In exchange for that inoculation procedure, your sentences will be commuted, you'll be free after that. So, lo and behold, they gave these six people inoculations, and when the smallpox epidemic occurred, they actually put these people in the room with active victims of smallpox and none of them got sick. And so this was the first time where people thought ahead, identified a group of patients, prepared them with a medical intervention and then showed that it worked.
Dr. Michael Koren:
18:24
During the same epidemic, there was a guy named Cotton Mather who was one of the Puritans in Massachusetts, and a guy named Onesimus who was an African slave, and they collaborated in 1721 on the exact same, during the exact same epidemic. First it hit the UK, Britain and then it came to the United States, of course, through the ships, and they actually put in over 200 patients from the Massachusetts colony and inoculated them, and the people that were inoculated had a death rate of only 2% during the smallpox epidemic, whereas if you were not inoculated, your likelihood of dying was 16%. So, again, this led to this larger structured experiment in the United States, which is interesting a collaboration between a Puritan minister and an African slave that helped the people of Boston at that time. So really, really cool stuff. So we call this the good. And again, these are not even close to the kind of structured studies that we do these days. But along the way, there's one other thing All the inoculated prisoners remain free of smallpox.
Dr. Michael Koren:
19:32
A couple little things. Three of the prisoners end up back in jail for future crimes. So that problem existed, but way back then, and one of the patients actually lied. So one of the patients in this study actually never disclosed the fact that she had smallpox before, and because she had smallpox before, it was very, very difficult for her to actually get the proper reaction from the inoculation, which was a sign that she was already immune to smallpox. So that's why we go through this whole business about making sure that we're getting the right patients into studies.
Dr. Michael Koren:
20:09
So let's talk about some of the not-so-good stuff. So who's here heard of the thalidomide babies? Oh yeah, hopefully everybody. Okay, so this was a drug that was highly marketed in Europe that led to birth defects and the typical thalidom. My baby is an unfortunate child that is born with no upper extremities. They're cut off toward the shoulder.
Dr. Michael Koren:
20:34
Ironically, a German pharmaceutical company was marketing this for morning sickness for pregnant women, and so this was a widely available drug in Europe in the 1950s and early 1960s. The German company tried to get this done in the United States and they hired 50 doctors to run a clinical trial of about 875 patients in the 1950s, and the principal investigators did this study and they noticed that the drug really didn't work very well for what they were advocating it for. So they were talking about it being for nausea, and it didn't really help. They were talking about it being something for insomnia it really didn't help. So the 50 principal investigators, after they finished the study, didn't use it. But in those days you didn't need to finish the trials before a drug got approved. So the German pharmaceutical company sent the drug to 1,270 other doctors in the United States who used it in a couple thousand patients. So the United States was basically spared from the worst of the thalidomide crisis, and the reason for that was because of a heroine named Francis Kelsey. Dr. Frances Kelsey, who was a physician who worked for the FDA, and she looked at the data from the clinical trial and the German company was trying to get full marketing approval in the United States and she said no, this is not a good drug, this should not be in the United States, and she blocked it. And so when she blocked it and the results came out that this caused birth defects, it led to a very important law in the United States, which was an amendment of the Food and Drug Act in 1962. And at that point that was the first really important legislation that required the clinical trials to be completed before you actually put the drug out in the marketplace. So that was really an important breakthrough in terms of safety.
Dr. Michael Koren:
22:27
And then an ugly incident is something I'm sure most of you have heard about, which is the Tuskegee syphilis study, and this study is really a horrible episode of unethical behavior in a study that was funded by the U. S. government. It was actually originally funded by the chairman of Sears Roebuck and he had sympathy for the plight of poor people in the rural South and wanted to donate some money for it, and he wanted to study how syphilis was affecting that population before there was any treatment for syphilis. So that started actually in the very, very early 1930s. And then the U. S. Public Health Service took over the study when the private grant ran out and they wanted to understand what happened in syphilis. So they enrolled about 400 black men they were all very poor sharecroppers without education and then they had 200 or so uninfected controls and they wanted to see what happened over the course of their lives and how syphilis developed complications. Well, syphilis is untreated, is a horrible disease, ultimately resulting in severe dementia and a number of other complications.
Dr. Michael Koren:
23:38
The patients that were involved in this were never told they were being observed in a study. They were just told that they had bad blood. There was no consent process. When the first antibiotics came out, which was they weren't very good in 1930s, but people were using arsenic and bismuth to try to treat infections, but these unfortunate men were not told about this. When penicillin came out, they were not told about it. In fact, when this group of patients was being looked at for participation in the military, when all the other recruits were getting injections of antibiotics, they were specifically banned from getting those injections because they didn't want to mess up the research. So this was really, really bad.
Dr. Michael Koren:
24:19
And then the government, the Centers for Disease Control actually looked at the study in 1969, while they were still following these people, and said okay, let's keep on going. And it wasn't until 1972, when an expose came out in the Washington Post, that people said what are you doing here? You're subjecting these people to the rages of this disease. That's very treatable at this point, and at that point it led to the National Research Act in 1974, which is really what started the current modern clinical trial movement. So after this, everybody that was going to be in a study had to give written consent. After this, everybody that's in a study had to be under the watchful eye of an institutional review board. So before we do any research, the researchers have to present all the study methods to an institutional review board to make sure it's completely ethical. All this came out of this tragedy.
Dr. Michael Koren:
25:15
So there's a couple of interesting elements to this, and one of the elements of it is that it took so long for people to respond to something that should have been so obvious. That's horrible, but the other thing is that it's created a lot of racial tension. There's a lot of people in the African-American community that haven't trusted research because of this story. But it's actually more of a complicated story than just about race, because this was actually conducted at a historically black university, Tuskegee University, and there were plenty of doctors and nurses that were part of the study that were African American. So it's really more, in my opinion, race is part of it, but it was also socioeconomic is that people that didn't have the knowledge were being exploited, and that's a sad part of this whole thing and that's one of the reasons why we have MedE vidence and other things.
Dr. Michael Koren:
26:04
We want our people that get involved in research to be really knowledgeable. In fact, we want you to be more knowledgeable than the average consumer, because we see that actually as a benefit of the research, and this is certainly a learning that happened through these historical incidences. So this gets into the concept of who's looking out for you. So, as we know, we have the Food and Drug Administration and that's an administrative body of the federal government and again, as mentioned, Francis Kelsey was a true pioneer who got the point across to the authorities that you really need to look at all the research data in a very structured way before you approve a drug.
Dr. Michael Koren:
26:45
And now the process of getting a drug approved is a mammoth process.
Dr. Michael Koren:
26:49
It takes tens of thousands of people to do this tens of thousands of volunteers and thousands of scientists and nurses and other people that are all part of this process, and it's a very expensive process right now, but it assures the safety and throughout this we're constantly sharing information.
Dr. Michael Koren:
27:07
So we have a process, for example, called a serious adverse event report and the responsibility of a physician like me. If I learn of a strange side effect in somebody that's involved in the study, I immediately have to send that information to the Food and Drug Administration and it's immediately disseminated throughout the world. So I come into my office every morning and I get reports from all over the world about what could possibly go wrong and whether or not the doctors involved there thought it was related to the study or not. It's almost never related to the study medication, but I get all this information and if I see something that's relevant to my patients, I can share it with the patients. So it's a cool part of the process. I mentioned the IRB, Institutional Review Board. Their sole goal is just to make sure that everything is done ethically and then, whatever possible, there will be a benefit to the patients for participating in clinical research.
Dr. Michael Koren:
28:00
And then you have excuse me, you have your investigators, like myself, many of whom are certified. I'm a certified principal investigator. That's like being board certified in cardiology. I have that certificate for clinical research and we are knowledgeable people that look out for our patients and can share insights that will hopefully not only affect you in that study but help you with other elements of your life, other medical issues, and we'll talk more about that momentarily. So when you get involved in a clinical trial, you can get involved in different stages. So before any study gets done in human beings, we look at it in animals, in test tubes, all kinds of analyses. So nowadays this preclinical, pre-patient information is so accurate and so valuable that we really screen out most of the side effects before a patient even touches that. Not 100%, but there's a really really good screening process before any patients get subjected to any of these medications that we use or procedures. It doesn't have to be a medication. But then, once it gets past the preclinical, then we have these phases phase one, two and three. So phase one is called first in human phase. So this is where you'll come in and for the first, maybe 100 patients that ever get a product. They are monitored 24/7 for a period of time it could be a week or two. Any curiosity has anybody here done a phase one study as a volunteer? We have one, so we might okay a couple. That's nice. So that's the first in human type of work and we do that in Jacksonville in our organization. We also do it in Inverness, Florida, in our organization, and we have sister sites in San Antonio, texas, in Orlando, that also do it. So this is again first in humans, where you come in and we look at you really, really carefully. You're constantly monitored and we want to make sure that it's safe in the first hundred or so patients that get exposed to a particular product. Then, after phase one, you go to phase two. That typically involves anywhere between 200 and 500 patients and that's when you get the dose right. So in phase two you have to see is the dose 1 milligram or 50 milligrams and we look at a number of factors to make that ultimate determination. And then, once phase two is completed and the company decides that they really want to invest in the product, which now is going to be a huge investment, they go to phase three and that's when you take the dose that you're going to actually use and try to get regulatory approval. And that typically involves thousands, if not tens of thousands, of patients. So just to give you a little insight, I do a lot of work with cholesterol drugs and the first cholesterol drug that was approved in the United States was called Lovastan and that was approved in a study of about 800 patients.
Dr. Michael Koren:
30:55
That was before I was active. That got approved actually as I was in medical school. Then I was active in the beginning in the mid-1990s, and the big drug that got developed then was atorvastan or Lipitor, and I was very involved with that and actually that's a drug that was developed in Jacksonville to a large degree. 13% of all patients who were exposed to atorvastan before it was approved by the FDA came from Northeast Florida, in part because of the work that me and my colleagues did here and that involved 3,000 patients. So we went from 800 for the first drug to 3,000. Lipitor is the fifth drug actually in the class and then Crestor or rosuvastatin had 12,000 patients to get approval. So more and more patients, despite the fact that we even have more and more experience in the class and now the studies that we're doing for these new cholesterol drugs involve 20,000 patients. So there's a lot of information that we get before these drugs are approved, but with that there's a lot of opportunity for being involved and the benefits from all that.
Dr. Michael Koren:
32:04
Phase four is the term that we use once a drug has been approved by the FDA, and this is what we call post-marketing studies. And there's even a phase five right now, which gets into all the pharmaco-economics. So when you have a situation where you're dealing with expensive drugs, who gets them? Some of these new drugs are using these incredible technologies, nobel Prize winning technologies. They're very sophisticated, they're very expensive to manufacture and not everybody can afford them. So how do we decide who gets what? And that's considered a phase five study. So who are the players? Well, I'm a principal investigator and my job is to lead the team and to be a voice of reason, hopefully, but also somebody that has the medical knowledge to answer questions when they come up, especially questions around, "could this be a side effect? Or, oh, my other doctor put me on this drug. Is it still safe for me to be in the trial? These are the questions that we get all the time. Then you have clinical research coordinators like Nalini and her team, who really are doing the bulk of the work.
Dr. Michael Koren:
33:07
Quite frankly, so, they're the people that literally are meeting the patients, scheduling the patients and then collecting all the information and they work with teams. They have helpers that do data entry and other things, but they're the core day-to-day people that are doing the work and of course, I'm around if they need my help, which is actually relatively infrequent because they're so good, but when they're new they would need our help more. But these are the people that are doing the day-to-day stuff. And then, most importantly, the volunteers and we're going to be talking to them in a second and sharing their experiences. Just a couple of the people that are behind the scenes, that you wouldn't know about it, but just to get a sense, there's something called the CRA or Clinical Research Associate, and these are counterparts that are usually on the sponsor side. So if a drug company or device manufacturer or somebody that's creating a lab test is going to hire us to help them do that development work, then they have people that are constantly in touch with us, helping us with whatever questions may come up and monitoring the progress of the study. The sponsor is the person that pays the bill. The way these things work is that we apply for a study grant and basically the study grants will say, ok, we're going to get $100,000 to deliver data for 10 patients and part of that budget, by the way, goes to the patients. So we do negotiate that sum when we get these grants. But we compete for grants with a lot of other similar sites like ours around the country. And then we have the Institutional Review Board and again they're an independent party that looks at the data and is also there if a question comes up. So if there's a question about the ethics of a study at any point, our colleagues in the Institutional Review Board help us out.
Dr. Michael Koren:
34:57
So the reason we do these trials is one to get the data that provides the scientific evidence as we talked about in the beginning needed to determine if a new intervention is safe and effective, to understand diseases and how they progress. We learn incredible amounts from this. Actually, one of the neat things for me as a cardiologist, as a curious, intellectually curious person, is that when I do clinical trials I learn so much about the disease area that I didn't learn in medical school. It really forces you to understand these things and the questions that come up in clinical research are so valuable for me to build my knowledge base. You want to improve the quality for the life for patients, both the patients that are in the study and the patients that get the benefits, the results of the study and ultimately improve health outcomes throughout the world. So we're going to now move to our volunteers and I'm going to let Nalini kind of take over the questioning here. But I'm real curious if you can maybe talk about what your experiences are. So, Nalini, go ahead.
Nalini Jones, BBA, CCRC:
36:01
Yeah, so we'll start with you. Louise, how did you get into clinical research?
Dorothy "Louise" Rohan:
36:05
I did. My first research was on contact lenses for bifocals, and then I went to CNS research and I did a research on a depression drug and I've been doing research with JCCR since 2008. And I can only say that I am so proud to be able to say that I volunteer for this, because I really believe in being able to give back and just be important towards something and the medication, and it also helps that I have a degree in hypochondria so, so-
Dorothy "Louise" Rohan:
36:58
Pardon me,
Nalini Jones, BBA, CCRC:
36:59
I think my mother went to school with you.
Dorothy "Louise" Rohan:
37:00
Oh, I'm sure she did. I recognize you, yeah um, but
Dorothy "Louise" Rohan:
37:05
I'm very happy to have to say I am a volunteer and I urge anyone who has a member of the family or themselves that think they would be interested to please give it a try
Dr. Michael Koren:
37:16
Very nice.
Nalini Jones, BBA, CCRC:
37:18
That's lovely, and I want to say that you were talking about how proud you are to have participated in so many trials with us and just to be a part of research, and that's kind of the way we feel on the staff side as well. Everybody can be a part of it, even if you think it's really small. What we're doing is for the greater good and everything, every study, every medication, even if the medication doesn't get approved, we've learned something medically, scientifically, that's going to help them when they develop the next medication. So, Tony, how did you get started with JCCR?
Anthony Langhals:
37:51
Well, I was online and I don't know if it was Facebook or just online where the JCCR, the research clinic, needed volunteers for their studies. So I went ahead and signed up and I got a call and they called me in and they said oh, we got these studies available. Which ones would you like to be involved in? I said, well, which ones do I qualify in? So some of the studies that I've been involved in is like the flu study, fatty liver study, Moderna study study, and I'm currently involved in the Vaxart study, where that is uh, they're developing a pill to uh take the place of a injection vaccine for covid. So you know, if you're a pill popper, I think you'll like this immensely, you know yeah,
Dr. Michael Koren:
38:43
Really cool technology
Anthony Langhals:
38:44
Exactly, yeah,
Dr. Michael Koren:
38:46
Instead of a shot for to protect people against covid.
Anthony Langhals:
38:49
Yeah, and likewise, I just want to put out that, uh, you know the staff the doctors, nurses and coordinators and staff are highly qualified, competent and professional. They exhibit great concern and care for the well-being of the patients. They're very personable and sociable and the studies that I have been in you know they have a packet that you have to review and, of course, sign and any questions I have, they fully and expertly answer those questions. So, like I say, the staff over there at least, I know you've got different sites: Lane Avenue, Fleming Island. Uh, you know, University by me, but you know the staff has just been great, you know, uh, working with them
Nalini Jones, BBA, CCRC:
39:40
So I just want to jump in.
Nalini Jones, BBA, CCRC:
39:41
he mentioned the packet that he receives. That would be our informed consent that everybody has to sign if you haven't done a research study. These forms can be a little lengthy, but it tells you everything about the study. It tells you the purpose of the trial. It lets you know how many others hundreds or thousands are going to be participating around the world with you. It talks about the medication in depth, the side effects that we already know. It's very transparent and it also has information about that IRB, that Institutional Review Board that Dr. Koren mentioned. It's in the packet with their information because they are the patient advocate. So everything that we do is completely transparent. Just to insert that and you made a really good plug for the rest of our sites, I think if we do a commercial, we can have Tony on it because, you advertise for us very well.
Nalini Jones, BBA, CCRC:
40:24
Thank you, but we do. We have locations on the west side of Jacksonville on Lane Avenue, we have one in Fleming Island, we're in St Augustine, we have three locations in Inverness and we do phase one through phase four trials. So we have something for everybody and we are so grateful that you guys continue to come back to us. I have a term, right. I call you guys repeat offenders, right, you just keep coming back but then you also become family to us. Do you ever have that experience? Is there anybody at our site that you've, or at any of our sites that you guys have, kind of formed a relationship with?
Dorothy "Louise" Rohan:
40:57
I still keep in touch oh, I still keep in touch with one of the ladies that I met there and, as I said, I feel like they're family.
Nalini Jones, BBA, CCRC:
41:10
That's lovely.
Dr. Michael Koren:
41:11
Thank you.
Dr. Michael Koren:
41:12
David's up next.
Nalini Jones, BBA, CCRC:
41:13
Yeah.
Nalini Jones, BBA, CCRC:
41:14
So we know you've done vaccine studies you, your wife, your granddaughter. Are you still currently participating in anything?
Dave Gnage:
41:20
Yes, I am. I'm in a study right now that measures changes in your voice to see if there's a change in, if that can be an indicator of a change in your heart.
Nalini Jones, BBA, CCRC:
41:33
Oh, the app. Yeah, that's cool.
Dave Gnage:
41:35
I don't know what the official name is. Yeah, can I say a little bit about how I got interested?
Nalini Jones, BBA, CCRC:
41:41
Absolutely.
Dave Gnage:
41:42
I spent my career in higher education and many times I was working closely with people in the health fields and one of them really struck me and this was in the floor above where my office was they were developing new medications and how they were using very small amounts and technologies to develop maybe 50, 60 different alternative medications for a particular disease or situation at a time. But of course, then when they identified some that might work, they went out into this process. At the same time, I was teaching statistics, so all these methods, how you scientifically test whether a drug or a process is successful. I was teaching that, so I thought okay, I'm retired, now I'm here in Jacksonville, I've got an opportunity to pay back all those people that took part in studies prior to this and leave a legacy and I want to since Tony said I took all his time.
Dave Gnage:
43:04
He took my time because he did a great job of talking about the relationship that we have with the staff at the center and that we kind of become a family together there,
Dr. Michael Koren:
43:16
Thank you
Nalini Jones, BBA, CCRC:
43:17
it's very nice
Dr. Michael Koren:
43:18
Yeah, so you made a couple points that I found particularly interesting.
Dr. Michael Koren:
43:22
One, is the current study that you're in is actually a study of technology, so it's to see whether or not, by talking to your phone, we can identify changes in your heart status. So not everything we do is involved drugs or devices. It's actually more and more technologies that we're looking at, so that's pretty cool, so I love that. Excuse me, the other thing is that you all mentioned this concept of legacy as being important to you, and that's certainly one of the drivers that we see over and over again and one of the reasons why we have so many quote repeat offenders. So I think that's really, really cool. Does anybody have an event that you can remember that like was, maybe had a profound effect on your day-to-day life or changed the way you approach something?
Anthony Langhals:
44:13
Tony, yes, kind of give you a story. I was in the Moderna study, the vaccine study 2020 timeframe, and that's when COVID-19 was sweeping across the United States and I'm in this study, I volunteered for it and I was talking to my neighbor about me being in the study and getting the vaccine and all this. Well, it might have been a placebo, but it was a vaccine because I got some side effects. But anyhow, I'm talking to him about it. He says no way will I get this vaccine put in my body. Okay, and I said well, you're entitled to your opinion. That's fine, you know.
Anthony Langhals:
44:56
But anyhow, about three, four months later, he develops the COVID symptoms and it got so bad he had to go to Memorial Hospital, spent two, three weeks in Memorial Hospital being treated for COVID symptoms. Ok, and once he got, once he got out, he came over to me and he says Tony, man, I learned my lesson. He says you know, you know, he says what kind of vaccines are out there? I said, well, like you know, Moderna, Pfizer, Johnson &amp Johnson, you know. And he looks at me. He says man, I'm ready to take them all and my family will take them all right now he says. I just don't want to go through the experience of what I went through with COVID for the two, three weeks that I was at Memorial Hospital.
Dr. Michael Koren:
45:46
Yeah, that's a great story. Thank you for sharing that.
Nalini Jones, BBA, CCRC:
45:48
Thanks for joining the MedEvidence podcast To learn more head over to MedEvidence. com or subscibe to the podcast on your favorite podcast platform
