The Dual Role of Clinicians as Researchers

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Announcer: 0:00

Waelcome 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.

Dr. Michael Koren: 0:11

Hello, I'm Dr. Michael Koren, the executive editor of MedEvidence!, and I always love to interview a kindred spirit and I have a kindred spirit today Dr. Manish Jain, who is a clinical investigator out of the Chicago area. He's braving the cold temperatures there we were just talking about that but we're excited that you found a warm spot to talk about something that's warm in both of our hearts, which is how to reach out to your community and talk to people about clinical research. So, one, welcome to Med Evidence! And two, why don't you just introduce yourself to our audience and tell us a little bit about yourself?

Dr. Manish Jain: 0:51

Yeah, definitely. My name is Manish Jain. I am a board-certified rheumatologist and internist and I run a busy private practice on the north side of Chicago. We take great care of our Cubs fans. If you're a White Sox fan,

Dr. Michael Koren: 1:05

You're in big trouble.

Dr. Manish Jain: 1:09

But and so, yeah, it's me and really a wonderful clinical team. And then, beyond that, I also serve as a principal investigator and I'm really based at our research site which is adjacent to my clinic. I'm also the regional medical director for Flourish within our Midwest region, so I help oversee now a handful and a growing handful of research sites here in the Midwest.

Dr. Michael Koren: 1:38

Yeah, and I will state that I love White Sox fans, so you can find somebody that loves everybody in our organization. So that's a great introduction, thank you. So how'd you get involved in clinical research? What was the impetus?

Dr. Manish Jain: 1:54

Yeah, so I had been interacting with a standalone research center gosh, this was maybe eight, 10 years ago and so participating as a principal investigator really in studies that were you know kind of bread and butter for a rheumatologist to participate in. I think about a study for you know a new agent for rheumatoid arthritis or you know a new agent for gout osteoarthritis. You know, these are kind of the bread and butter conditions that I see as a rheumatologist. And you know, I kind of started off doing it as a little bit of a hobby. It was just like a fun thing for me to offer to patients and just kind of kept things exciting for me in clinic. And so I did that for a while.

Dr. Manish Jain: 2:38

And then COVID happened and then everything just changed right, changed for all this, changed for our patients, changed for our colleagues alike. So during COVID a lot of the you know, especially kind of really early on, when the pandemic was at its fiercest, a lot of our patients suffered in the hospital with really serious forms of inflammation in their body, especially in their lungs, and so pretty early on many of the medicines I use as a rheumatologist of high interest to kind of help fight that inflammation brought on by COVID and so kind of a you know weird wild story. One of the agents was actually a JAK inhibitor, Janus Activating Kinase Inhibitor. We were studying it in rheumatoid arthritis, and so an opportunity presented itself to perform a study with the same drug, but in an inpatient setting for COVID patients.

Dr. Manish Jain: 3:39

And so basically you know, myself and a handful of resident physicians, training physicians, banded together and during the height of the pandemic, when we really just didn't have a lot of options to offer our patients, we didn't have any clinical trials going on at our kind of smaller community hospital. We enrolled 55 patients in the hospital. So that was kind of a big inflection point and really helped me kind of understand the power of clinical trials in just a really really different way and just how, even though my lane is just a little bit narrower as a rheumatologist how really it can be applied more broadly to all of our patients in need. So that's my story.

Dr. Michael Koren: 4:29

Well, that's interesting, so I'm in suspense. Did the JAK inhibitor work for COVID patients?

Dr. Manish Jain: 4:34

It did. It actually reached an FDA approval. I was really proud to see a drug from its inception, even helping a sponsor come up with how to study the medicine, giving input and seeing it all the way to an FDA approval. Really a very special.

Dr. Michael Koren: 4:56

Very exciting, that's fabulous. So how long did it take you to get comfortable approaching patients about research? And do most patients look at you skeptically when you present this concept to them, or how do they respond to you? So I bring this up because a lot of physicians are just intrinsically uncomfortable with approaching patients about research opportunities, and that's a very important part of the skill set of an accomplished clinical trial professional.

Dr. Manish Jain: 5:25

Yeah, I see a lot of synergies with how I talk to a patient in clinic. I might be presenting them, you know, a new therapeutic option and I'm going to present pros and cons, risks and benefits. And I drive, I lean on that experience quite a bit when I'm speaking to patient about a clinical trial. Many time, not all the time, but many times these are patients I've had years long relationship with. You know, I know their families, I know just a lot about the patient. Not all the time though, sometimes its a new patients I'm presenting it to. I think just having an honest, transparent discussion; I think just knowing what I'm talking about is also really important, just like I need to know what I'm talking about when I'm presenting a trial to a patient, be able to field questions and not just turf them to another team member, not just, you know, turf them to another team member and I think, really just understanding where the patient is coming from, what motivates them. You know many of my patients are driven by altruism. They want to help. Many of my patients will sign up for it because they want to help everyone who's immunocompromised. So, just like in clinic, understanding the patient's value system and understanding if and how a trial can kind of fit that value system.

Dr. Michael Koren: 6:54

Do you have any things you can share with us on how you can assess that, any little turns of phrases or ways that you get clued into what would drive a patient, get them interested in clinical research?

Dr. Manish Jain: 7:07

Yeah. So I think first it's like just identifying the clinical need. If I have a patient in need, the need could be for so many reasons they don't have access to a certain treatment. The need could be that you know this is really something new for them, they, you know. So understanding that need and then really tying how I speak to a patient based on that need. So I'll just give an example we, you know, one of the bigger studies I enrolled into was not looking at a vaccine. It was looking at something a little bit different, a monoclonal antibody. So it's a monoclonal antibody that would help potentially protect patients against an infection In this case it was COVID and so helping explain to a patient. Vaccines are super important for my immunocompromised patient, but vaccines don't always uptake quite as well.

Dr. Manish Jain: 8:03

They don't always work quite as well in my immunocompromised folks, just because it might be the disease itself, it might be the medication that I'm required to use and so helping my patient understand well, listen, this is a way to potentially supplement that vaccine response. So I think understanding and that was in that that you know was quite motivating for for a lot of my patients so I think, uh, understanding where they're coming from, explaining it in lay terms and and leaning on kind of my experience as a clinician and having discussions with patients, that that's, that's what I, that's what I've used.

Dr. Michael Koren: 8:41

Right, yeah. And there are also social situations for people. Either people are struggling with their finances or people are having difficulty affording a certain medication. Often, that can drive our discussion with regard to why a patient might be interested in something that we're doing.

Dr. Manish Jain: 9:01

Absolutely, and even something as simple as transportation. You know I'll have patients who you know they'll come see me on my clinic side. Unfortunately, I cannot provide transportation for a patient when they're coming to see me for a clinic visit. We can provide it, often in the context of a clinical trial visit, and so, you know, sometimes I have to remind my patient, you know they oh, you're here for a clinic visit today and of a clinical trial visit, and so you know, sometimes I have to remind my patient, oh, you're here for a clinic visit today and not a clinical trial visit.

Dr. Michael Koren: 9:29

Yeah, so just for the audience, when we run clinical trials, we compete for grants and the grants include stipends, often for patients, including their expenses, and sometimes the stipends can be used for other medications that are important for them to be on as part of the research. So there's a lot of opportunities that we have a little discretion over not complete discretion, but some discretion.

Dr. Manish Jain: 9:53

And the other thing that I'll lead on a lot is helping patients understand all the close monitoring that they're going to receive. I'll give one example. We had a patient enrolled in one of our cardiovascular studies. This wasn't my practice patient, but it was a patient of a close colleague of mine who's a cardiologist, and so we were just doing like a standard phone checkup on this patient. I have a really smart physician assistant on the research side who just picked up the patient just sounded a little short of breath, just didn't sound right, and so that patient was actually in midst of a flare of their congestive heart failure and I was picking it up over the phone and we you know the patient just didn't have the opportunity yet to bring it up to his cardiologist, but we picked up on it first and that patient went right away to the emergency room. So that's just one example, but this happens day in and day out in our practice.

Dr. Michael Koren: 10:52

Yeah, yeah, that's a great point. And an ancillary point is that when you develop a skill set as a clinical trialist, it kind of overlaps your therapeutic expertise clinical trial list. So I'm a cardiologist and, like you, I was involved in the COVID trials, mostly the COVID vaccines, and it's not because I was an expert in virology or infectious diseases or vaccines, it's because I knew how to run clinical trials. And all of a sudden we had a scale clinical trials where we're putting hundreds of people in in a very short period of time as part of operation warp speed.

Dr. Michael Koren: 11:26

Both you as a rheumatologist and me as a cardiologist are sometimes doing the same studies, but we can bring different things to the table. So, for example, I know that we're both involved in lipid studies, looking at, for example, lipoprotein(a), which is a form of LDL cholesterol that seems to be particularly atherogenic and runs in families. And so how do you, as a rheumatologist, talk to people about something that may be a little bit different than what you would talk about in the clinic but is relevant in terms of your skills as a clinical trialist?

Dr. Manish Jain: 12:06

Yeah, and the way I look at Lp(a) is we may not be talking about in clinic, but we ought to be. So this was a real evolution kind of in my thinking and, just frankly, my education as well. So we know that my patients with rheumatic disease let's just use rheumatoid arthritis as an example are at a much higher risk for cardiovascular disease. So we actually think of rheumatoid arthritis as probably a diabetes level risk for the formation of heart disease and we ought to be talking about our patients about modifiable risk. You know we ought to be talking to patients about statins.

Dr. Manish Jain: 12:44

We may not be managing their statins in a rheumatology practice, but we should be eyeballing their medication list and you know, say hey you got to talk to your primary care doctor and you know, see if you know if we can get you on, you know, on this risk mitigation treatment.

Dr. Manish Jain: 13:02

So when it comes to something like Lp( a), it's it's actually really fun for me in clinic to bring it up to a patient and you know, I kind of described, as you know, maybe it's like a stickier cholesterol and it's been tied to you know, these bad outcomes and it's it's something that we don't think you can diet or exercise your way out of, but it probably does drive a lot of the risk for, you know, for bad events and up till now, you know, didn't really have anything to offer other than, you know, just checking it. But that's changed in the context of a clinical trial. Not only can we check it, know your number, know your risk, but we may be able to do something about it in the context of a study, and so when I present it to patients, they're usually very excited to not just have the level checked but, if it's high, to think about doing something about it.

Dr. Michael Koren: 13:52

Yeah, and then another area of overlap is the concept of inflammation. You talked a little bit about that before, but it's been well known that patients, for example, that have rheumatoid arthritis are at higher risk for cardiovascular events compared to match patients that don't have rheumatoid arthritis. So is that an area of focus or concern, or how do you express that to your folks?

Dr. Manish Jain: 14:15

Yeah, so quite a bit right. We know that our patients who have tighter disease control for their inflammation, for their rheumatoid arthritis over time have better cardiovascular outcomes. Study after study has shown that. So that's another opportunity to engage a patient, either in clinic, maybe in a clinical trial. That you know your rheumatoid arthritis is uncontrolled, you're on a ton of prednisone, as an example, which we know is connected to cardiovascular risk, and we've got to get this disease under control, be it through an agent that's FDA approved, that I've got access to samples in my fridge, or be it through a clinical trial for rheumatoid arthritis, just as an example.

Dr. Manish Jain: 14:57

So really helping patients kind of understand. You know, I'm somehow very fond of telling my patients in the clinic like I care about your pain. I do, I care about it. What I really care about is all this systemic inflammation. I care about your heart attack risk, your infection risk over time, and my job is to really help stamp out this inflammation and help mitigate risks while I do it. So that's something where I get my practice and my trial practice a lot.

Dr. Michael Koren: 15:29

Yeah, and that's an important holistic view. And so interestingly and perhaps counterintuitively, even though we may be focused on one question, when we do clinical trials, we actually have to think about patients holistically. So, as you point out, people that have inflammatory conditions such as rheumatoid arthritis, may be at mortality risk from cardiovascular events, and by talking to them about that, you're actually taking a very holistic view of the patient.

Dr. Manish Jain: 15:57

Yeah, absolutely. I think my passion in life right why I feel like I was put on this earth was to improve the lives of my immunocompromised patients. Ten years ago I think I had kind of a myopic view of that. Right, I was going to improve their lives within the context of the medicines that I, as a rheumatologist, classically would prescribe. But now my perspective is so much different. Right, I still am prescribing those medicines and you know, I'm getting their disease under tight control. But I'm also thinking about their BMI, I'm also thinking about their lipids, I'm also thinking about their vaccination status. I'm also thinking about, you know, have they gotten up to date on a malignancy screening? So these are all ways that I think I'm convinced. I don't think I'm convinced that the trials have made me into a better clinician.

Dr. Michael Koren: 16:50

Yeah, and that's very, very well said. So I'm going to switch gears on you a little bit, and I also know that you're passionate about physician education and in fact, you're going to join me here in Jacksonville in April to do a physician training course on how to become more effective as a clinical trialist and, of course, teaching doctors who may not be that familiar with the concept of GCP or Good Clinical Practices what that means and that that is one of the elements of the skill set that a good clinical trialist has the many other elements that we get into during the course. So just tell us a little bit about how you got interested in the physician training piece and maybe some of your strategies on how physicians learn best.

Dr. Manish Jain: 17:37

Yeah, absolutely I love teaching. It's been a part of my career for quite some time. So actually before I got really busy with clinical trials, I participated quite a bit in resident education.

Dr. Manish Jain: 17:50

I was actually a program director for a transitional year program.

Dr. Manish Jain: 17:54

That's a training stopping point for a future radiologist or dermatologist and being able to lecture about rheumatic diseases. You know, I think sometimes some of my conditions kind of are a little, they almost feel a little mystical or confusing even to medical trainees, and so demystifying it. You know, helping helping our docs understand how to recognize and refer, maybe even take care of patients with our conditions has always been a fulfilling part of what I do. It's really fun for me now to bring in the clinical trial aspect into that and teach, you know, training doctors about well, okay, you're prescribing this medicine, how did that medicine come about? Helping them understand how to read a study right, what are you supposed to look at when you're evaluating a study. You know what are some of the questions you should kind of poke at a little bit when you're evaluating a study. So I'd say, being able to kind of educate trainees on the clinical trial process and just how to critically evaluate you know data as it comes out Super fun, super fulfilling for me.

Dr. Michael Koren: 19:09

Yeah, that's. A great point is that it may be a bit of a lost art, but reading a technical journal publication is something that not all physicians are particularly good at, and once you have some clinical trial experience you get much better at that and it really enhances your understanding of the particular project, the hypothesis that's being tested, the therapeutic area and also the interface between your patients and what they can get out of the latest and greatest in that therapeutic area. So I think we do spend a little bit of time on how to read the literature during our training program.

Dr. Manish Jain: 19:49

Yeah, absolutely it almost. You know, when you get kind of involved in this clinical trial world, you really get this very foundational, fundamental, in-depth understanding of the studies and you know it's almost like you, almost you start following studies, like you start following sports if you're an avid sports fan. You really know the ins and outs of them and you bring that back into clinic on a day-to-day basis and that's really fun is being able to close that loop for patients.

Dr. Michael Koren: 20:20

Yeah, absolutely. And this next question may reflect my bias but how do you feel about this standard of training quote, unquote, and I put that in big, big quotes where somebody says, okay, look at this website, doctor, and listen to it for 30 minutes and then you're trained versus some of the experiential training that we typically did back in residency and fellowship and what I believe is a great way to train people after our quote, formal training?

Dr. Manish Jain: 20:55

Yeah, so I I saw the evolution of medical training and kind of the change of what it's turned into now during my medical training, you know.

Dr. Manish Jain: 21:05

I mean we were kind of the from 2006-2009, kind of the trailing end of the last days of the giants, where you know you had the you know overnights in the hospital, 30 hour, uh, training shifts and, and it wasn't to say that it was all good. Right, I mean there were some negatives there, it was tired and you know, but but really I, I like I'm, I'm really thankful that I had that opportunity.

Dr. Manish Jain: 21:34

I don't think I'd be the same doctor if I had dreamed uh if, if I didn't have that opportunity during during my training, to have those long, long uh you know nights bleeding into days and be able to care for my patient with with that continuity.

Dr. Michael Koren: 21:54

Yeah, no doubt we were just talking about that earlier today that you know, when I was training, being on call every other night for months at a time was not unusual and we had shifts up to 36 hours. And that part of medicine from a training perspective has gone away, and I think, probably for the worst overall, although, to your point, we don't need people necessarily absolutely fatigued making important decisions, but there's ways to deal with that. But getting to the more broad question, in clinical research, what's the most effective way to teach other people to get up to speed?

Dr. Manish Jain: 22:35

Yeah, I think it's got to be multimodal, and so I think there's a role for modules and, you know, standardized, formalized training. There's a role for, you know, lectures. There's definitely that. That's, I think, a core component of the foundation. There's a role for doing as well. You know, to be that investigator, to perform the assessments, to have that direct patient-facing contact as well, is really important. But I think there's that third pillar that has, for me, helped make me the investigator I am today, and that's mentorship. And it's sometimes hard to find mentorship within clinical trials. For me, that's been. I think, one of the most exciting things about being part of a clinical trial network like Flourish Research is that I don't just have access to amazing patients and amazing studies, but I have access to amazing mentors, and that has just been really, really important and a big driver of my growth over time.

Dr. Michael Koren: 23:35

Yeah, no doubt the concept of mentors has been extraordinarily important for me and to your point, when you're just looking at online modules, you don't get that sense, and there's very many softer points of being effective as a clinical physician and as a clinical trialist that you're just not going to get other than through experience and watching how other people do things and finding your niche. You don't have to do exactly the things the way your mentor did, but at least you see different styles and that eventually helps you develop a style that you get really comfortable with and get really good at. So I think that's super important. So, Manish, this has been a fabulous conversation. Before we sign off, are there any other major things you'd like to share with the audience with regard to your career experiences, your interfaces in clinical research?

Dr. Manish Jain: 24:36

Yeah, to me, I think it's just. It's all about the synergy I really lean on. You know the things that.

Dr. Manish Jain: 24:40

I hope make me a strong clinician, you know, I think, directly carry over into being an investigator. There's definitely differences as well, but to me I kind of see it's more about the synergies and similarities of the two. And I guess the last other closing thought I'll leave you with is it's super fun. You know, I think we all Dr. Koren, you and I both have some colleagues that maybe aren't having as much fun as they ought to be practicing medicine, right, I think we you know we we see high rates of medical burnout, just just as as an example in our profession. I really think to get to participate as an investigator and kind of carry these dual roles, like you and I do, it's really fulfilling and and I think we wake up just with a lot of purpose and a lot of excitement and excitement and ready to tackle the day, and for that I'm truly thankful.

Dr. Michael Koren: 25:32

Yeah, and you alluded to this, but part of our medical culture as old school physicians is that we do clinical practice, research and teaching.

Dr. Michael Koren: 25:44

It's all part of this trilogy that are very, very important to us, that fulfill us as as uh, as physicians, as physicians that want to be a cut above other people, and, um, research is a big part of that. So, Manish, uh, yeah, this has been a great interview and I just want to say that we'll have some show notes that give people information about how they may want to participate in our training session coming up at the University of North Florida in April, and so we encourage people physicians this is really physician-focused to look into that and learn more from folks like us and other members of our educational group that will be talking about the many, many elements of clinical research that you may want to get involved with or, if you've been a little involved with, you may want to make your skills get to a higher level through this type of interaction. So, again, I'm excited to work with you at the University of North Florida in April. We'll have more information on the show notes and thank you so much for being part of MedEvidence!

Dr. Manish Jain: 26:45

Thanks for having me Really appreciate it.

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