Building a Community Through Clinical Trials

Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts hosted by cardiologist and top medical researcher, Dr. Michael Koren.

Hello, I'm Dr. Michael Koren, the executive editor of MedEvidence, and I'm really excited about this podcast. Today I have a really neat fellow who is actually a pioneer in the clinical research industry and he and I are going to talk about how we get clinical research into communities. So welcome, Steve Satek, to MedEvidence! Thanks for being part of what we're doing.

Thank you. I'm really happy to be here and to share my experiences.

That's great. So, Steve, you were just getting me up to speed a little bit on your background, and we have a lot of cross-currents, which is kind of neat. We'll talk about some of those, but for the audience, why don't you just start us off by letting us know a little bit about your background and how you ended up doing clinical research?

Yeah, sure, Thank you. So I think it all honestly. My career here really started with my parents, who always instilled this like bubble of curiosity; always had me inquiring and researching things, even as a young kid. And, um, I actually went into college and got a degree in biochemistry and molecular biology, because it actually had that science aspect to it. I started out as a bench researcher, which was a kind of a natural flow for that, but then I realized I wasn't getting enough, social interaction and and, communication with people as opposed to Petri dishes, so I moved into the clinical trial space. It was kind of a natural progression and I started as a coordinator. I love the research aspect of everything we're doing, trying to help people and trying to get new drugs out there to make societies better. I started out at Northwestern as a bench researcher and moved into the Chicago Center for Clinical Research where I worked with Dr. Michael Davidson and Kathleen Drennan, who kind of took me under their wings and really helped me grow to who I am today.

Two legendary names in our business, for sure.

Yeah, exactly, you know, and I just I really appreciated their style of leadership and mentorship. They were more than leaders, they were truly mentors and it wasn't necessarily like the time we spent in meetings, that they told us what to do and how to do things. It was more like, at the end of the day, Kathleen or Michael just coming by my office and just sitting down and talking and really trying to help lift me up a little bit to grow to who I am.

Yeah, well, and you've done incredible things during your career. So you were at Chicago Center for Clinical Research, kind of learned the business, and then you went off on your own. So tell us about that journey. That must've been scary.

You know it's scary, but that's what part of being an entrepreneur is all about. You know, I always laugh that people, even in my neighborhood of Chicago people say, oh, they should put a coffee shop here or they should put a donut shop here. And I always say who's they and it's they, is you and it's who an entrepreneur is, Is the person going out there and doing that. So after working with Michael and Kathleen at Chicago Center, I ended up going to a couple other jobs and gain more experience and leadership in the industry and eventually I just realized that you know, the city of Chicago has a- It's a huge city and the number of research centers that are there it's very, very small comparative to the size. So I just saw that there was a need, especially in my community.

I live on the north side of the city and honestly, there was very little, if any, research being done up there and if you had to join a clinical trial you had to commute all the way downtown to Northwestern or Rush or University of Chicago, which frankly is not very convenient for a lot of folks out there to get on the L and head down that way. So I wanted to bring research to a community as opposed to actually bringing a community to research. And so that's why I opened up the research center in it's a community called Andersonville and I just you know, and I know that the community that I lived there for now it's up to 34 years or something. I just know it really well and I know that there's people who want to help other people and people who want to get involved. It's kind of that altruistic type of community. So it was a perfect place to open it and starting from scratch and you yourself started something from scratch you really have to lay a foundation.

Yeah, so tell us about that. Did you go to a bank and get a loan, or how'd you start with the initial capitalization? Or you have to. You take on a big lease, a lot of, a lot of financial burdens on entrepreneurs.

Yeah, you know. So, yeah, I did go to banks and started on that process and then, as I was moving toward that, my business partner, my, we decided to actually shift it to more angel investors. So we had a lot of friends out there who had some money that they were willing to to invest and they believed in us. They understood the business plan, the need for for research in Chicago, so it ended up being a, just private donations that actually helped not really donations, cause they got their dividends back and that sort of stuff, but, that allowed us to actually not be beholden to a bank, and that sort of stuff.

So it was kind of scary doing that, and you know, I think in any business starting out the first few years, you're you're going to have tough times, and you know you got to, like, make sure you get your head above water, and eventually we did. And I think what we had to do, though, and getting away from the financial matters into more of the community development, I thought it was really, really important that we establish a presence in the community and brand awareness in the community through education. So it took a lot of community talks at libraries, at park districts, at senior centers, and we were doing two, three talks a week, just to just what is clinical trials.

It wasn't: What is "My center at the time was called great lakes clinical trials. it wasn't. What great lakes was it was "What is research? What does it mean to get involved? Um, and I think that's really important, not only for just the general public, especially for um underrepresented communities out there who really are afraid of clinical trials, and we needed to kind of break through that stigma with a very personal approach. And you know, just doing an ad and paper or TV or radio is just not going to do it. We needed to actually see people talk to them face to face and we did a significant amount of that to build up our brand awareness.

I love that. I absolutely love that it gets into a couple of concepts. But I have a few specific questions first. So what year did you start Great Lakes Clinical Research?

That was we incorporated in 2013.

Okay, so still, you know, a little bit of a rough time just coming out of the Great Recession, a little bit of a risk there. And what kind of studies were you able to find in the beginning to kind of lift you up?

Yeah, you know one of my career paths that happened in the mid-2000s. I was working for a computer-based cognitive testing company called Cognitive Drug Research and honestly, that's what really started to develop my entrepreneurial spirit. It was a British company and I opened up the North American headquarters in Chicago and built up an entire team there and through that experience I really got involved in memory research. And even before that we were doing a lot of Alzheimer's work MCI Alzheimer's prevention. Before that we were doing a lot of Alzheimer's work MCI Alzheimer's prevention. So when I started my center I had quite a number of contacts in the industry and was able to secure some really good trials in the area of Alzheimer's disease and mostly prevention. Also, prevention was a kind of a hallmark of the work that we've done at Great Lakes.

Nice. Was that at all related to the bench research you did or unrelated?

No, actually completely unrelated. I actually started out in oncology and the bench research was all in oncology and my first couple of studies I did as a clinical trialist was in oncology. I left that all behind when I left Northwestern in the early 90s.

Interesting, interesting.

So one of the things that you mentioned that is super fascinating to me and we're going to spend the rest of our time together focusing on this issue is the concept of getting people engaged in clinical research, educated in clinical research, without necessarily recruiting for a specific clinical trial, and there's two expressions that I like to use to help people understand this.

One is just the concept that the industry should be looking at research-ready patients and ultimately finding the right study for them, rather than trying to find a perfect patient for a trial that has very arcane inclusion-exclusion criteria, and, unfortunately, most of the work that we do now is we're given this inclusion-exclusion criteria, which isn't necessarily reflective of the way we think about things clinically, and the expectation is that we go out and find those people. But the approach that you used actually is something that I align with philosophically, which is let's tell a lot, a lot of people about research, and once we tell them about research, then the biggest barrier to getting them involved in studies is gone, which is that they're not scared, they're excited, they know what the value proposition is. So, before I go to the next thing, why don't you comment on that?

Yeah you know I think it comes down to building trust in these communities. n d what I think what's important is not to just be there when there is a study, but to be there at all times, and be present in the community. That means, maybe its doing talks, maybe it's actually just being there to support that community on one of their own personal initiatives that they're doing. Maybe it's something unrelated to research complete, like maybe there's a food bank in an area that they need some volunteers and you send people there to help support them. So you ingrain yourself within a community at all times and you use education to get people to understand what clinical trials are about and when a study is available that's right for them. Then they're a little bit more apt to actually come in and participate in research. And we were talking about this earlier. But it's not only the people that you're connecting with who would come into research, but it's their family members, it's their neighbors and they start talking.

What a great experience we had at that clinical trial center. And one of the important things I think we did early on and continue to do was we would go to these communities, we'd offer these educational systems and we'd embed in the community, but then we would have the community come into our research center, come visit, come see what the center is like. What? Because there's there's a mysterious cloak around a research center. People don't know what it is. It's a regular doctor's office, basically. But people don't understand that, and so we would bring the community members and some of the leaders and the influencers within those communities to the center, walk them around, show them the steps of a clinical trial, like what happens, in what rooms do they have and what people are you going to meet with? That actually goes a very, very long way to building what you need to do to get out into a community.

Yeah, I love that.

And the other concept that we're talking about is how things go viral, and you're alluding to that, and the statistic I like to share is that when you ask a general population that hasn't been involved in research before are you interested in clinical research and this has been done both in the US and Europe, and only about 40% of people in the US say that they would be interested in clinical research as a care option. In Europe it's actually lower than that. But if you ask people that have actually completed a research study, would you do another one? 97% to 99% of patients say they would do another one. So there's very few products out there that you have skepticism before people are introduced to them, and once they are introduced, they love it and they want to come back and do it again. So this concept of going viral and people doing multiple studies and then spreading the word to family and friends, I think is a real relevant one. I don't know if that's been your experience.

Yeah, exactly, and I'm impressed by your knowledge of the numbers and I can't recall them off the top of my head. But one of the other numbers that I always thought was impressive in a bad way was the number of those folks who have never been approached about research from their primary care physician. And that is, I think, where we're missing a huge opportunity, because people trust the primary care physician, they're going there, they're actually watching their lives as they grow older, and if their doctor would say, hey, have you thought about a clinical trial, it would be a total different world. But it's a very low percentage of people who have ever been approached.

Yeah, I'm familiar with that. I think the last number I read was only 8% of people in their whole life have ever been approached about doing a clinical trial. So imagine that, given the fact that there are literally thousands of clinical trials out there at any given time grass effo

l have people who are sitting around the kitchen table saying have people people have have have hey, I went into the center, this is what happened. It was really great and honestly I say you sit around the kitchen table but a lot of times we have that kitchen table coming into our clinic all together. The family would come in to help support their loved one in the research process, particularly in the Alzheimer's disease and memory loss area. You have a lot of children in different relatives that will come in with the family and I think that that's an important concept. It's not always just one person joining a clinical trial. Yeah, technically that one person is signing the informed consent form, but it's actually the family members, the clergy around them, the neighbors, the community that are supporting that person in clinical trials.

Yeah, so we'll finish up our discussion with two things. First, can you think of somebody, Steve, a patient, who had a profound experience in clinical research at your center in Andersonville, Chicago, which, by the way, I visited, and it's a fabulous place, completely embedded into the local community. I've never actually seen a site quite as well embedded in the community, really part of the fabric of the community. So you did a fabulous job of making that happen. So congratulations on that. But I was wondering if you could think of an anecdote of somebody that came to you afterwards and said, wow, this was transformative in my life somebody that came to you afterwards and said , this was transformative in my life

Yeah, I can actually think of really two really good examples. One is more of a experience of what it is to get into clinical trials. The other one is more of a medical one. But we've had a number of individuals, especially during the pandemic, that joined clinical trials and had joined a trial for a vaccine, for example, and had never even thought about being in a trial before, and at the end of their sessions they were like that was a really great experience. Their doctors were fantastic. They actually spent time with me. They're not rushing in and out of the exam room to get to the next patient. They're sitting there making sure that all their questions are answered, that there's nothing left That's that's ambiguous. So we heard a lot of really positive feedback about that.

I'm really proud of our team at our center who actually do care about our patients and want to make sure that their issues are being addressed on a personal level. From a medical perspective, one of the early studies we did at Great Lakes was a complex regional pain syndrome study. It's a devastating pain disorder. We had our very first patient on that study was using crutches to actually walk, because they had difficulty with this disease and, honestly, by the end of their session their participation in this study, they were walking without the crutches and so and this disease does not have good treatments out there right now. So this access to these medications that are more innovative, during a clinical trial process, help this person's quality of life dramatically, and when you see that happen it brings tear to our eyes, Like, literally, our staff just um wants to embrace them and it's it's. It's so moving that we've improved people's lives.

I love that, I love that. And then my final question is that you recently retired, so how's that going? And, um, do you still have the bug? Is it possible that at some point we may see you, uh, come out of retirement?

You know, I, I don't know, um . And that's the beauty of and I am right now. I think when I did retire and I retired last fall I was still very, very involved in the research community, nationally and internationally, speaking at conferences and that sort of thing. I was very, very busy. I probably was putting work in the industry before myself, and so what I've done in retirement is really kind of focus on myself internally and kind of self-improvement sorts of things, whether it's physical or mental health, and that, I could tell you, is going absolutely fantastic and I'm happy as a clam, still believe completely in the clinical trial industry and I will support it however I can. So I have still volunteered my time for certain organizations like the Global Alzheimer's Platform Foundation, the Society for Clinical Research Sites. I've actually spoken at some of their conferences just to offer, you know, my area of expertise and, honestly, stepping out of it for a bit and actually looking at the industry from a different viewpoint, I think I actually can offer some unique perspectives because I'm not bogged down with the day to day.

Now you asked me about will I get involved in a more bigger way down the road? I don't know, but my whole plan of retirement is really to kind of like dump my brain, get everything out of my brain and then see what kind of fills in my brain. But one thing that will never leave is that I have some incredible friends, colleagues, that are all still in the industry and I will always be by their side to support them and what they're doing, whether it's through mentoring other people. I had great mentors in my life and I think it's my job to return that that experience to younger people in people in the industry, so I can help mentor them to be better at what they do. So I will always do that sort of thing. I'm not going to say what I'm doing, what I'm not doing, because I don't know, and I will see what happens.

Steve, this has been a delightful conversation. I know from the viral nature of doing clinical research. There's a really good chance we'll probably see you again in the industry. I won't be surprised to be on a stage with you at a conference talking about the value of reaching out to the communities to get people involved in clinical research. And thank you so much for being a guest on MedEvidence!.

Great Well thank you very much. It's been an honor.

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