Building Public Trust in Clinical Research

Join Dr. Michael Koren, CEO and Executive Director of MedEvidence, to explore how education and transparency can reshape the public’s understanding of clinical research. Dr. Koren shares his passion for putting patient welfare first and highlights how Med Evidence empowers individuals to make informed decisions about participating in trials. He discusses the importance of building trust, breaking down misconceptions, and helping communities see research as a valuable care option. Tune in to discover how storytelling, visibility, and patient engagement are helping redefine the relationship between the public and clinical research.

Transcript

Jimmy Bechtel: 0:01

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations, shaping clinical research today. I'm Jimmy Bechtel, the Chief Site Success Officer with SCRS, and I'm joined by Dr. Michael Koren, the CEO and Executive Director of Med Evidence. Here to share a little bit more about Med Evidence and their work with SCRS. Dr. Koren, it's awesome to have you longtime SCRS supporter and member, why don't you start us off with a little bit more on your background and what you're doing with Med Evidence.

Michael Koren: 0:36

Sure. First of all, thanks Jimmy for having me. It's always fun to talk about our industry and clinical research in general. For the folks listening in I'm, Dr. Michael Koren, I'm a cardiologist. I've been involved in clinical research for over 35 years. It's a little scary to think about my tenure, but that's been a longstanding tenure. And I've played many, many roles in clinical research over that period of time, including being the past president of the Academy of Physicians and Clinical Research on two separate occasions. I'm very involved in publications, particularly in preventative cardiology, and I've run a site network called the Encore Research Network that recently merged with the Flourish Research Group, and I'm currently the Chief Scientific Officer for Flourish. But along the way, as you pointed out, we developed this platform, which is mostly a patient facing platform called Med Evidence. Med Evidence is operated as an independent company that's actually run through an independent advisory board that ends up making all final decisions for the company. And within this company what we do and our passion is to get the word out to patients about what we do in clinical research. And we do that by virtue of multiple types of formats. The most popular format are actually podcasts where we have typically two physicians speaking about a particular issue, and that discussion helps people understand what we know about a particular area of healthcare, what we don't know about a particular area in healthcare, and the process by which we learn more about that particular area. At this point, we've had literally hundreds of conversations, and we also have powerPoint presentations and other what we call master series information. We break down a therapeutic area, whether it's women's health or it's forms of cancer, or treating cholesterol issues, orthopedic issues, whatever the case may be. These are led by very knowledgeable folks, mostly physicians who then help the public understand how they should take the information that's available to them and make good decisions from themselves and their family, including whether or not getting involved in a clinical trial would be a good option.

Jimmy Bechtel: 2:53

Thanks, Dr. Koren. It's a really interesting perspective and one that not a lot of other parties in the industry have taken. We talk about patient centricity and putting patients first, and it's great to hear of an instance, an opportunity, a means in which we can elevate the voice of the site of the patient and their relationship with the site and how we give a little bit more transparency into the work that's being done. Really excited to talk through this. Can you introduce us a little bit more to the why that led you to the launch of Med Evidence and what your goals are? You alluded to some of these and I'm sure that our audience can draw some conclusions, but maybe succinctly talk about some of what the goals are and the desired outcomes for the work that you're doing here.

Michael Koren: 3:38

Yeah. It's a great question so thanks for that. It's about the patient, Jimmy. I come from a standpoint of studying medical ethics and in fact, I was the Chief ethical officer for ACRP and APCR in the past. When you look at the ethics of medicine. One of our ethoses is that the welfare of the patient supersedes all other things in medicine and all the things in research. The welfare of the patient is numero uno when it comes to any scientific process or any clinical trial, we always have to keep that in mind. Now, sometimes it's very easy to get lost into the details of a research protocol and forget about the number one principle, but my passion is to always remind everybody that this is our number one principle as clinical research professionals. Now, the flip side is that. Over the years, the general public has gotten a sense that clinical research is risky and they don't always get information about all the benefits and the value of participating in clinical research. And so that's the other part of my passion is one advocate for the patient welfare, but two. Let patients know that maybe you're missing something if you don't find out about participating in a clinical trial in your community. Because through clinical research, people typically learn a lot about their disease state, whatever that may be. They enjoy a very nurturing environment, which is actually rare these days in medicine. We're all so stressed in medicine. I still practice cardiology part-time and there's such pressure in the clinical offices to get people in and out, that patients don't always get that nurturing effect that they're looking for, that care that they're looking for and patients typically get that care in a clinical research setting because we spend more time with patients and addressing all their issues. That's a big piece of what we do. In many cases, there is a legacy effect of participating in clinical research. A lot of the illnesses that we study are genetic illnesses that not only affect the patients, but also their family members. And of course, every person who participates in a clinical trial is creating his or her own legacy because that information will actually inform doctors and other healthcare providers throughout the world. How cool is that? And then there are actually tangible resources that patients can get through participation in clinical trials. In many studies we provide free medication, many studies, we provide free imaging and lab information, and we also provide stipends for people that offset the cost of their travel time and pay them a little bit for the time that they spend getting involved in these studies. There are multiple different advantages for patients to participate in the study, and the safety of studies is much better than it was years ago for a number of reasons. One, the things that we're testing are much more sophisticated and much more focused on safety than they've ever been. Number two is that before any of these products even touch a patient, we have ways of evaluating whether or not they'll have any off-target effects, meaning affecting things in our body other than what they're intended to affect. Our ability to limit those off-target effects is better than it's ever been. This means that the overall safety experience of a patient is much better than it was years ago. The other really important piece of the puzzle is that we are all part of this community and clinical research is a wonderful way for physicians and other providers, non-physician folks that participate in clinical research, patients, advocacy groups, people in the political sphere, we can all come together to create knowledge that makes healthcare better. I love the community and the cooperative elements of doing clinical research that are so super important. To prove that the cool thing about what we do is in most industries, all of our secrets are held very tightly. If you're in the automobile industry or the food industry or other industries, you don't wanna tell your secret formula or what makes your car better than somebody else's. But in clinical research, what do we do when we finish a project? We project every detail of that project to the entire world. How cool is that, that we share all this information? If you wanna be part of this really neat enterprise, patients have the opportunity to do this. Right now I think less than 10% of patients in the United States have even been approached about clinical research. Quite frankly, that's a shame because for the average adult in the United States, there is probably one or more clinical research opportunities for you as we speak, and there's really good reasons to take advantage of them.

Jimmy Bechtel: 8:13

There's a lot to tease out there, Dr. Koren, but I really appreciate the perspective and the intention around this being what can we do to enhance patient and community visibility, but also assuredness. The comfort and approach to the clinical research enterprise and really help them because like you alluded to you hear about one negative instance, you know, the plane crashes and everyone doesn't wanna fly planes yet. We know that millions of flights occur every single day and one instance tarnishes that for thousands of individuals. The same concept can be applied to clinical trials. You hear of one challenge or one issue and it gets publicized and then everyone has this hysteria around clinical trials. Yet there's so much good in thousands and thousands of patients that are benefiting from clinical trials on a daily basis. Taking steps like this and the work with Med Evidence to enlighten around that and provide that positive lens into the experience and the benefits of participating in clinical trials is really commendable and exciting process forward.

Michael Koren: 9:23

Absolutely. Well, thank you for that Great comment.

Jimmy Bechtel: 9:25

How can better visibility in the trials change, in your mind, the way people view research as a care option? What is the desired outcome of these goals and what direction will we take when we have that better visibility into the direction that we're headed?

Michael Koren: 9:46

Sure. Really important question, and that depends on whether or not we're looking at a narrow situation or a more broad situation. For a narrow situation, let's say that you have a genetic dyslipidemia, a cholesterol problem that runs in families, and one that we're working on right now is called lipoprotein(a). This is a cholesterol issue that was discovered about 30 years ago. It runs in families. Families that have this problem have a much higher risk of heart attack and stroke than other families, but unfortunately we don't have any way of specifically treating that problem. Until recently, now we have four or five products in development that actually treat lipoprotein(a) incredibly effectively. In fact, we've shown in studies that we can reduce lipoprotein(a) by over 95% with these products. That would be a situation where we want people to understand whether or not they have this particular problem. Are they genetically predisposed? Do they have high levels of LPA? And then if they do, let them understand that there really is no solution out there for this problem, but that in a clinical research program, you may get access to a product that will change this. Now we don't know yet whether or not lowering these, this level of this lipoprotein will result in any major benefits for patients, but all the science suggests that it should, and so you can be involved in that process so we figure that out. That's kind of the narrow case. Then in the broader case, you use this analogy with air transportation and how one plane incident will get everybody nervous about taking a plane and that's just human nature and I understand that. What I like to remind people in clinical research is that for people who have never actually gotten on the plane, who have never actually done it, when you ask them whether or not they'd be interested in getting involved in clinical research, only about 40% of Americans and Europeans say that yes, they would be interested. But if you take that same group of people who have actually completed a clinical trial and you ask them, would you do it again? Then 97 to 99% of people say, absolutely I would do it again. Jimmy, how many products or services can you think of that before you actually experience it, you're really skeptical, but once you have your first experience, you're sold for life.

Jimmy Bechtel: 12:08

The list is small. And in fact, Dr. Koren, I would argue I could actually probably think of more instances where I've been excited about something and I've used it, and then I've been disappointed, so I'm less likely to use it. You could easily make an argument that clinical research is beating the curve, with that type of trend.

Michael Koren: 12:24

Yeah, it's totally unique and it's great point. I love the way you said that. It's such a interesting phenomenon and that's why we need to get this out in a broad way, so hopefully that makes sense. You have narrow situations where you're trying to help people understand one particular medical problem, and then the broader concept where we just want people to get involved in research because the net effect is that they're gonna love the experience.

Jimmy Bechtel: 12:47

Yeah, it's an excellent point and, I can see and start to draw the lines between how Med Evidence will support some of that work. It's around this concept of community assurance and seeing that other people have had success. That concept of positive reviews and positivity around the clinical research and what we're seeing from the site and the patient interactive side and being able to bring that back to the community. That will ideally chip away at some of the things that you've talked about and really illuminate all the positive aspects around clinical trials.

Michael Koren: 13:20

It's a very fulfilling experience for patients. If, you're in a good center with good people that are doing the right thing, and virtually all the people involved in your organization, SCRS falls into that category, then you'll be in good hands and on average be extremely thankful that you got involved as a patient.

Jimmy Bechtel: 13:38

I couldn't agree more. I wanna kind of wrap us into talking about the future then, Dr. Koren. Platforms like Med Evidence and the work that you're doing, how do you envision them shaping public trust in medicine and clinical research? What is our endpoint here, our gold star that we're working towards? And what does the future look like when we can do things through platforms like Med Evidence and provide some of that better public trust?

Michael Koren: 14:05

Sure. There are two initiatives that we're working on as we speak. One is to help the public understand that there are community-based sites and these could be privately owned, they can be academic sites, they can be parts of university, et cetera. But these are community resources where you'll have an excellent experience because these places focus on research as a care option. They have dedicated teams that will allow patients in different communities to get involved in research. In some cases, they may have a narrow focus. In other cases, they have a broader focus in terms of the possible diseases and situations they're dealing with and sometimes this is also true just for healthy volunteers. What we want the public to understand is that there are groups of people that have put together what we call sites, which are locations where research is done at an excellent level. Med Evidence is now going through the process of having sites submit information that proves they get to the standard of care, that they're what we consider Med Evidence: centers of excellence. We're really excited about that. We launched this concept that SCRS, we got tremendously positive feedback from the people that were at the meeting. We're gonna start our first certifications next month in November of 2025. Around the country, patients will be able to look at the map of every place that research is being done in their communities and see which of these places have gone through the process of showing that they approach research in such a sophisticated and professional way, that they meet the standard of a Med Evidence: center of excellence. We're excited about the introduction of that program and we're excited that our independent advisory board will help all to make decisions to show the public that we're dealing with these very, very high level places to get access to clinical research projects. That's one thing. The other thing that we're starting to do is we're actually starting to do more and more patient interviews. Where patients, that are very typical patients, come in and talk to me or another clinical research specialist in whatever the therapeutic area is, whatever the disease state is, and we will kind of walk them through about what the standard of treatment is. With everything we do, we always advocate for the standard of treatment. We don't want people to do research in a setting where they're below standard of treatment. Research should always be on top of the best care available. We want these patients that become part of this Med Evidence initiative to share their stories, and then we'll break it down for the public on a podcast with the actual patient saying,"Hey you're having a problem with let's say diabetes and you're doing pretty well, but now there are some diabetic medicines that may be better for treating your blood pressure or may be better for ultimately reducing certain complications. And we would encourage you to get involved in a clinical research trial at wherever this is occurring in the United States to be part of that initiative.:" Or we can say,"Hey, you know what you're doing everything possible. You're doing a great job. Pat that person in the back and say thank you for sharing your story and keep on doing what you're doing." Or we may tell that patient, you're doing great for yourself, but you have a genetic condition, so you may also wanna inform your family members that. They might get some benefit from learning more about whether or not they have this particular disease state or this particular risk. And then seeing what their options are." The concept is to actually tell patient stories, show the doctor patient interaction on screen, but also show where research might fit in if necessary for people that present their stories. Those are two big initiatives that we're now providing as part of the Med Evidence platform.

Jimmy Bechtel: 17:54

Excellent, Dr. Koren. I think those are really interesting in the fact that it's multifaceted. We're not just approaching this population, this potential and current patient population with not only a way to get in, but also a way to stay in and, like you said, stay engaged with their medical care and potential clinical trials and other options along their treatment journey however long or short that may be to continuously engage them and keep them as part of the great care that we can provide through clinical trials or whatever that may be. It's really excellent to hear about all that Dr. Koren, thank you for your time today. Really excited to have this conversation and to learn a little bit more about the great work you all are doing with Med Evidence.

Michael Koren: 18:37

Well, thanks Jimmy. Thanks for having the conversation, check out Med Evidence!.com. There's an exclamation point at the end of Med Evidence to show the emphasis. And give us your feedback. I think you'll enjoy the formats that we present, the information that we present and we send out newsletters on a regular basis. So we encourage you to be part of our email universe. You'll learn a lot about different areas of medicine and also learn about research as a care option and whether or not touching research would have some benefits for you or your family members.

Jimmy Bechtel: 19:06

Excellent. Dr. Koren, I couldn't agree more, and I encourage as well, everyone, to check out the great work that the team is doing. For those that are still listening, I wanna make sure to bring attention to our site focus resources as well made available on our website, myscrs.org like other publications, other episodes of SCRS Talks and our Site Solutions Summit, where you have opportunities to engage with our partners like Dr. Koren and others in the industry. For now, thanks for listening, tuning in, and until next time.