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This is the Leap Together podcast, where we highlight top leaders driving breakthroughs in clinical research and life sciences.
Yeah, that's true. I think they aren't able to have the interactions they want with physicians, and so I have more time because I'm doing research and I'm willing to sit down and talk to them, and they really appreciate that.
Zach:Hi, Zach Gobst here. I'm the host of the Leap Together podcast, where I chat with leaders in clinical trials and patient advocacy to explore how medical breakthroughs come to life. Today, we're fortunate to be joined by Doctor. Michele Reynolds, family medicine physician by training. She's been doing clinical research for thirty years and has done around 400 trials and has been an ACRP certified principal investigator since 2003.
Zach:Pillar in the research community, a great partner to us over the years, particularly with helping with more robust vaccine research, and we've only heard great things from the patients we've supported together, too. Grateful to have you on.
Dr. Reynolds:I'm glad to be here.
Zach:So thirty years of clinical research. Did you ever think you'd end up here? What happened?
Dr. Reynolds:It was, I think, a lucky accident. I had a good friend who was an OB GYN, a few years old of me doing some research, clinical research in his practice. He called me one day and said, You read EKGs, don't you? I was like, Yeah, every day. And he said, I haven't seen one since I was a resident.
Dr. Reynolds:I've got a study. Can you read my EKGs? I was like, Sure, can you fax them over? I'll read them and send them back. He said, Oh yeah, that's perfect.
Dr. Reynolds:Well, that was fine. I read his EKGs. About a year later, he called me and said, Oh my gosh, they want me to do a hypertension study. I'm a gynecologist. I don't do hypertension.
Dr. Reynolds:Why don't you come do that study with me? And I was like, Oh gosh, I've got a full time practice. I'm a part time hospice doctor. I have a four year old at home. How much time is this going to take?
Dr. Reynolds:Oh, it won't be bad at all. So I started helping with the hypertension study, and then he decided he could do research from his own office with his own staff, and I became the only doctor at the research clinic. I just took over. It just ballooned on from there.
Zach:It's funny how we all kind of have our own unintentional journeys, or a lot of people do. You were kind of the smartest person in the room to solve a certain problem and then kind of kicked things off.
Dr. Reynolds:I knew how to look at a study and report it in a journal and see if it looked like it was a good study, if it looked like the data was good. But the mechanics of doing a study, I really did not know anything about that. I was very lucky that I had two very experienced coordinators, both had been doing research for more than twenty years, and a really smart site director who knew everything. And they taught me the right way to do research, so I was lucky that I didn't just fumble along and try to figure it out on my own.
Zach:Yeah, and I might come back around to learning more about the people who helped support you getting here. But also interested in if you had any inflection points. I don't know if it happened in your first study, the twentieth study, the one hundredth study. Anything that looked for you and made you say, Hey, this is my calling. There's something going on here that I really like.
Dr. Reynolds:Yeah, I think it was just accumulation of studies and you see that you're finding new medicines and it's making a difference in people's lives. The fact that it's very detail oriented, which I think most physicians are Type A personality, and it just really fit me. I like everything done just so and make sure everything's done the right way, that's how you have to be with research. So it just really fit me. Also being a female physician, full time private practice, raising a child and home stuff, it's a lot.
Dr. Reynolds:This had a little bit better lifestyle doing research. Most of my hours are pretty regular, and I don't have to go to the hospital and don't have to do on call. I am on call, but you rarely get phone calls. So for lifestyle, it was better for me, too. I wasn't looking for that necessarily, but it worked out well.
Zach:Yeah, you've certainly kind of found your groove, and it does help drive better research outcomes and systematically is leading to what drives better healthcare. Terms of other things that happened for you, whether it's improved your skill set or your mindset or maybe the way you think about education, Curious about your own kind of development in the process, too.
Dr. Reynolds:Yeah, just doing different trials and looking at different things, you learn more about the topics, about the disease that you're treating, and yeah, you learn new things all the time. Was just telling somebody a story about the RSV. We had an RSV vaccine in the 1960s. Children who got the vaccine, if they caught RSV, they were way sicker than children who were unvaccinated. Nobody understood why that worked because we didn't know as much then about how the immune system acts.
Dr. Reynolds:So I read all this information about this, and I was like, Woah, where did that come from? They didn't teach me that in medical school. So now we understand how vaccines work, and we can have an RSV vaccine that doesn't make things worse instead of better. So all that T1, T2 dominant pathway things that you all heard about on TV with COVID, we didn't know that back when I was in medical school in 1982, so they've been around a while.
Zach:Yeah, and it's great that you kind of get to be an active part of driving. What is going to work better and being a close practicing, being a part of the care process, but also going through it with patients and seeing what happens with them. I'm sure even in thirty years there's been a lot that's changed. Curious also, starting with patient education and if you've seen your role shift, how your relationships with patients have looked over the years. Curious what's been the same, but what might be shifting to?
Dr. Reynolds:Well, I only do research right now, but I do believe in patient education. What I hear from patients is that their doctors don't talk to them very much. Doctors are so busy, and so I have the time. So I sit down and sometimes I answer questions that are not really about the study. Generally for every study I try to have an explanation of what the study is all about, what the medication does, what the study is all about, and hopefully a level that patients can understand.
Dr. Reynolds:But when they find out that they can talk to me and I'm accessible, I often get questions about other things, which I'm happy to answer if I know the answer because I think that's important. Sometimes patients don't understand why they're taking this medicine or that medicine, and if you explain it, they're like, Oh, okay, my doctor never said that. So I feel blessed that I found something to do that I don't have to deal with all the hassles of private practice because I know they're struggling.
Zach:Yeah. I bring it up because for me, in Leapcure, that kind of space of like, Hey, patients really have all these things on their mind, all of these concerns. There's not really a great place for them to go. Clinical research and its process of educating patients and the space that we create, and sometimes it becomes conversations about other things, too. It can be really impactful on a human level because there is like, Hey, we want to treat something that's going on, but like patients feeling supported in whatever they're going through medically.
Dr. Reynolds:Yeah, that's true. That's true. I think they aren't able to have the interactions they want with physicians, and so I have more time because I'm doing research and I'm willing to sit down and talk to them, and they really appreciate that.
Zach:Then, yeah, also kind of similar question around your sponsor interactions. I know not every sponsors act the same way, but in general, over the years, curious what that's looked like and if there's anything that's kind of shifted over time too.
Dr. Reynolds:A lot of sponsors use contract research organizations that help run their studies, so that's a little bit different. It used to be a lot of sponsors had their own monitors who were part of their company. So that's been a difference. The monitors, you become friends with them. You say, Hey, tell me if we're not doing something right.
Dr. Reynolds:I want to do the right thing. I want get your patients and do the study the right way, so please tell me. And they teach you things, too. They say, Oh, you know, you to do things this way for this study. This is how this sponsor wants it.
Dr. Reynolds:So there are some differences between sponsors on how they handle things, but you get to learn that from the staff that comes out. The monitors come out and look at your data, checking, making sure you did everything, and so it's wise to have a relationship with your monitors because I think when some sites I've gone into, they feel like the monitor is there to if it's a bad thing that the monitor is there to check up on you. They're helping us. They're making sure we're doing things right. I'm like, The monitor is our friend.
Zach:Yeah. I think that's a great perspective, and part of the reason my company's taking on doing a podcast is I think, in my experience, and I'm curious about yours too, because you've been doing it much longer than me in clinical research. What I've noticed over time is a lot of people in this space are doing it because they want to help improve people's lives. By taking a partnership approach and us being together against the problem instead of us against each other, It's not just that it feels better to work that way. I've actually seen it improves the quality and the speed of research to work with the monitors to try to share perspectives.
Dr. Reynolds:We're all on the same team. We all want the same outcome. We want to take care of our patients and get a good drug out on the market so everybody can benefit from that.
Zach:Part of the reason why we wanted you to have on is because when we've worked with your team, we've kind of had that experience in how you work with patients. But to me, kind of the inflection point of my business, and I'm kind of curious about if you had anything similar in research, was when we were working with sponsors and we were working with sites, and we got more perspective on the challenges they were trying to solve, and we were engaged in a way to work together to support patients for the better experience or find a way to set up investigators to be successful in how they follow-up by understanding more of the details, we slowed down how we did patient recruitment in a way to make sure we were gathering that context and connecting it. I think our impact has probably been two or threefold what it was before we had that insight. I'm interested in your practice if you've had anything similar. Maybe you've already had these principles.
Zach:For me, was a little bit jumping in, but interested if anything like that happened for you as well.
Dr. Reynolds:Yes. We have recruitment people who help us, and they have an open line to me. If they have a question about something, they call me and ask me. And I've been in situations in the past where they just flooded my schedule with patients, and I look at them and say, Oh my gosh, this guy's on dialysis. He can't do any study.
Dr. Reynolds:Why did they give him an appointment? So I like something where we've had somebody who knows what they're doing talk to people ahead of time and, yeah, call me. She calls me, and even then sometimes patients don't mention things and we get them in the office and find out they're on a prohibited medication or something. You can't catch everything, but you could try to funnel the right patients into the office. We are seeing people who are likely going to qualify for the study.
Dr. Reynolds:So that's helpful. That was not the way it was worked when I was first starting in practice, and like I said, I've had situations where during COVID, I mean, I'd have 80 patients on my schedule. That's not even possible. And it was those things are frustrating for investigators, but, again, having somebody to help you get the right patients in, that makes such a difference. It makes such a difference for the site and for the patients that they feel like they're doing something that it's appropriate for them, and we are happy that we're getting patients who look like they're perfect for the study, just the patients we're looking for.
Zach:Glad that that's shifting. In our business, I think we tried to be intentional about shifting our approach because of that, because if we're dealing with those issues downstream, the patients aren't going have a good experience, the investigators aren't going to want to work with recruitment. Also, when you think about your staff and the monitors, the way that you think about communicating with other people involved in clinical trials. You mentioned to treat monitors as your friends, but interested in any other insight in terms of what's really helped you improve quality of research if there's something where maybe it was communicated more or figured out kind of where there were gaps? Anything come up in that area?
Dr. Reynolds:Yeah, training is really important for all of us. I'm a big proponent of training and reading all the stuff. I mean, protocols, investigational drug brochures. Investigational drug brochures are like everything they know about the drug, and those are weighty scientific documents. It's hard reading.
Dr. Reynolds:I'm a good reader. I've literally read probably a couple thousand IVs at this point in time, and they're hard reading, but that's my responsibility as a doctor, for the principal investigator, to know about the drug. What are we dealing with? What are the potential side effects? How does it work?
Dr. Reynolds:So if I see a patient that maybe this is not going be the right thing, I will say, Yeah, I don't think this is a good study for you. That's my responsibility too, is to take care of the patient. They're my patients when they walk in the door. My patients for the purposes of the study, and I'm going look out for their well-being. Training clinical staff, my coordinators, I mean, we sit down and talk about things, we're all doing all of our training so we know about the drug and stuff.
Dr. Reynolds:Plus I try to do some spot checks on the charts. There's a lot of things I have to sign. I'll just sign my name. I look at the page and say, Oh, wait, this question, should that be answered yes or no? I don't think that's right.
Dr. Reynolds:So I take it back to them and say, What? Why did you put this answer here? And then they're like, Oh, well, so then we find those little things where we're not doing something exactly right or something where we may need to, you know, put down a little notation of why this happened or what this is all about. So that makes it clearer for the sponsors and the FDA if the FDA ever shows up. Hopefully not.
Zach:Putting together a protocol up front and being proactive about everything, there's usually little nuances of ambiguity that you catch downstream.
Dr. Reynolds:Yes. You think you've got it all, and then you get a patient and you're like, Wait a minute. This protocol does not address this situation. Thankfully, that's when you contact your monitor or yay for medical monitors. There's a physician, usually a physician or maybe a PhD, who is a medical monitor for every trial.
Dr. Reynolds:If it's a medical kind of question, I call them. Send them an email and say, This is what I've got here. How do you want me to handle this? Because I don't want to get in trouble later, they say, Why did you put that patient in the study? So it's always, you know, that's one thing.
Dr. Reynolds:You train on everything so you understand it, and if you have something that's not clear cut, talk to the sponsor. They're the ultimate authority on how they want the study run and what they're looking for exactly and make a yay or nay, and then you know what to do.
Zach:An advantage of having a podcast is we can highlight folks that are making great impact, that we're excited to chat with you. And there's also a chance to pay it forward. Are there any folks that you want to express gratitude toward, whether they're colleagues, mentors or partners that have helped you make an impact in research?
Dr. Reynolds:Doctor. Doctor. Erwin Kerber. He was the gynecologist who got me started. I don't think he intended it to be my lifelong career at this point, but yeah, thank you for getting me started on that.
Dr. Reynolds:And my coordinators Jill and Claudia from the very first practice there, they were a big help in teaching me how to do research because it's very different than private practice. And, I had a site director named Diane Bolanone, very knowledgeable, very helpful. Those three taught me the right way to do research, and I don't think most people who do research had anybody with that much experience to really teach them the right way. So I would say anybody who wants to do research, find a mentor. Find somebody like me or someone else that you know that's been doing research for a while, and they can teach you how to do it the right way.
Zach:That's fantastic, and as someone who's been doing it as long as you, to express gratitude, but also understand, Oh, there's so many people that can support you in the clinical research community to move things forward.
Dr. Reynolds:Yeah, I'm really happy to talk to people about that and say, Hey, was a great choice for me. Not necessarily what I knew that I was doing, but as it turned out, it's been a really great thing. It fits my Type A personality. You can see I love this stuff. I love the science of it and everything.
Dr. Reynolds:The patient asked me a question and I was telling him all about stuff, and smiled really big at me last week and said, I can see you really love your job. I said, I do. I said, Science and medicine is just so cool.
Zach:It can be really exciting. You're figuring out how do we do better and how do we work with a system and improve a system to improve the way things are going, and so that sense of optimism, that sense of excitement for what we're doing next, things being different.
Dr. Reynolds:I've been lucky enough to work on a bunch of drugs that were revolutionary, that have changed the face of medicine, and that is so satisfying to know that you've been a part of that. I think the biggest thing I ever did was COVID vaccine trials. I put my own health at risk of doing that. But when you sat and saw that on the TV every night, I had to do something. I had lobbied to get a COVID study because I wanted to be part of the solution, not the problem.
Zach:I have similar experiences with that, where I think we gave away some free recruitment work. Recruiting for COVID was kind of interesting because we worked on both vaccine studies and also people recovering treatment for things like long COVID, and there wasn't a playbook for it. You kind of had to figure out how do we kind of get creative about putting our best foot forward and do something where we can see the impact and make a difference in terms of really transforming people's lives from where it was for much of 2020?
Dr. Reynolds:Those of us who worked on those things, we changed the world in a good way. Very proud of that.
Zach:Yeah, it's awesome to hear your perspective, having done it for so long, still kind of being excited about the space.
Dr. Reynolds:I still love it. I'm old enough to retire, but I just want to keep working.
Zach:That's great. So yeah, I guess my last question is, you've built this foundation of having worked on 400 ish trials. What's next for you, or how do you think about your future involvement in clinical trials?
Dr. Reynolds:I'm planning on continuing working. My plan had been to work till I'm 70, but now that I'm getting closer to that, I'm thinking, Well, I could cut back and do three days a week or something. You know, maybe I could just work a little bit. I'm a widow, so work is a big part of my life. I do other things too, but I just love what I do and I'm an experienced investigator.
Dr. Reynolds:I hope that there'll be someone else, some newer ones hired that I can train and teach them how to do it. I have had, there's some sub investigators out there that are doing research now that I trained. And, so I don't know. I don't know what my plans are to keep working for now. Just can't imagine not being part of this.
Zach:For thirty years, for you, you still have so much intrinsic motivation whether it's the same amount of hours, less hours, but finding ways to explore is inspiring. Am really grateful to have you on. Thanks so much, Doctor. Reynolds.
Dr. Reynolds:Thank you so much. Nice to talk to you.
Leapcure:That wraps up our conversation with Doctor. Michele Reynolds, principal investigator, physician, and a true leader in clinical research. With over two decades of experience and more than 400 trials under her belt, her work continues to shape the future of medicine. We're grateful for the insights she shared today and for her ongoing commitment to advancing the healthcare clinical trials community and beyond. Thanks for listening, and until next time, stay informed, stay engaged, and keep pushing for better health outcomes for all.