The Unseen Side of Clinical Trials

 After working in the clinical research industry for decades, Jim Kremidas unexpectedly found himself on the other side – as a patient searching for a trial. Despite Jim's extensive experience and vast network, finding a trial proved more difficult than expected. 

Many of us have not experienced a clinical trial from the patient's point of view. This enlightening episode discusses Jim's perspective as a trial participant, as well as advice for both patients and research professionals on how we can streamline participation in trials.

Transcript

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Jimmy Bechtel 0:01

Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. SCRS Talks allows our partners and those that we work closely with to take a few minutes to address issues of industry concern, share exciting achievements, and to learn more about our extensive community. Today, we are lucky to have Jim Kremidas, an adjunct graduate faculty member at Wake Forest university in the clinical research area, as well as the clinical development strategist with an organization called the STEM, Jim, it's great to have you with us today, if you wouldn't mind elaborating a little bit on your introduction, so we can learn a little bit more about you.

Jim Kremidas 0:43

Sure, Jimmy. And thanks for having me that I'm really looking forward to this conversation. So I started my career at Eli Lilly and I was there for 24 years, spent time in sales and marketing through procurement and into clinical research. where I actually started the first patient recruitment organization at a big pharma company in the, I believe, in the industry. And a lot of what we did was focused really on site performance as well as, of course, you know, reaching out to patients to make them aware of studies. But when I retired from Lilly, I went to what used to be Quintiles, now IQVIA, and ran their patient recruitment group for about five years. And then transitioned to another CRO and after that, I did some consulting for a while consulted sites, suppliers pharma companies, CROs, et cetera. And then ultimately wound up as the executive director for the Association of Clinical Research Professionals, ACRP. And that's where our paths first crossed, Jimmy, right? Absolutely, yeah. Yeah, but I retired from there about two years ago and have since been teaching at Wake Forest as well as doing consulting. So one of the things that I think is unique about my career is having started a big pharma and then going to a CRO and then working closely with sites and at ACRP, I learned an awful lot about what sites do and what they go through, particularly at the study coordinator and, and PI roles. And so, that was really, for me, intriguing. I learned a lot. I didn't realize how much I didn't know, if that makes sense. And then, most recently, I've been a patient in a clinical trial which really, again, was an eye opening experience. You know, being the person who's actually in the trial and dealing directly with site personnel. So that's, that's sort of a unusual, I believe career path, if you want to call it a career, you know, going from big pharma to CRO to site support to actually being a patient that I'm working, you know, where I'm a patient of a site. So yeah, it's it's really been fun.

Jimmy Bechtel 2:47

Well, it is definitely a we'll call it a broken road, right, Jim? It's not a typical path for a lot of people, but that really is what we're here to talk about a little bit today is, is your experience coming from the different aspects and how you contextualize that having ultimately and most recently been a patient. So you shared that experience after your cancer diagnosis. However, you also mentioned that finding a suitable clinical trial, even with your extensive industry knowledge and network proved really to be challenging for you. So can you maybe start us off by elaborating on the difficulties that you faced during that search and the role your connections might have played in helping you find that trial?

Jim Kremidas 3:30

Yeah. Great question, Jimmy. So you know, when I first got the diagnosis, you know, like everybody, I was upset and Concerned and I was trying to get as much information as I possibly could about the disease and what my options were and one resource I found pretty easily online through a Google search was a not for profit organization called Beacon, B C A N, Bladder Cancer something network awareness network, I think, but I learned a lot from them and during that period, I started looking into potential clinical trials. I was still at that point undergoing standard of care. And I wanted to understand that too, which BCAN was very helpful with BCAN was very helpful with. But you know, as it turned out, the standard of care didn't work for me. So I started looking around and talking to people. You know, I went to clinicaltrials. gov. I did a bunch of Google searches and found a number of other organizations that do trial listings and things. The bottom line is, even with a little bit of a medical background, it was very difficult to understand, number one, if I fit the inclusion and exclusion criteria, and number two, and you'll really appreciate this, if I did try to reach out and contact a site, I either got no answer, or I would leave a voicemail and nobody would ever call me back, you know, basically it was, it was unbelievably difficult to even talk to somebody about participating in a clinical trial. So I started reaching out to my network of friends in the industry. A really good guy, his name is Randy Hall who gave me a lot of good information, but I first reached out to, I was talking to Craig Lipset. We were talking about my retirement and he said, Oh, well, you know, I know somebody that's had bladder cancer. His name is Randy Hall. And, and I said, well, I used to work with Randy at Lilly. So he reconnected us. And Randy then got me in touch with. somebody at Johns Hopkins, who then got me in touch with somebody at IU in Indiana, that had more of a state of the art type of diagnostic tool. It's called blue light cystoscopy. So I reached out to this urologist. I was fortunate to be able to get into his practice. And shortly after that is when we, we identified the clinical trial that Was actually being conducted out of Johns Hopkins, but one of the, one of the sites was the IU medical facility. So that's kind of how I fell into this. But again, it shouldn't be that difficult. It should not be that hard for people to number one, get information in layman's terms. And number two, really find out where are there clinical studies near me that I at least have a probability of qualifying for. Then number three, when someone does reach out to a site or an organization, you know, customer service, I mean, answer the phone, talk to people, try to help them out. And I get it. I get it. That sites are really busy and you know, maybe they're done enrolling, but man, it was really frustrating to try to get ahold of someone that I could talk to. about whether or not I could, you know, even participate in a given trial.

Jimmy Bechtel 6:42

Interesting, Jim. It's not an uncommon, unfortunately, sentiment that we hear from a lot of the patients and even the sites that are trying to find patients. There seems to be some sort of disconnect in the industry. And we talk a lot about reaching new patients, but you know, we, it seems like from your experience, we have people. Knocking on our doors, trying to get into our clinical trials and we can't even give them the service that they need. So I, I want to believe that this is an uncommon experience, but it sounds from what I've heard and discussions I've had not all that uncommon. But, you know, you identified the right trial. You mentioned some of the challenges that you had during that process, but yeah, that's Maybe talk about that concierge level services and, and what way might having someone that can help liaise as a patient, a kind of a patient concierge might make a difference.

Jim Kremidas 7:37

Yeah, that's another really great point, Jimmy, is once I was made aware of the trial through my urologist he connected me with an oncologist and, and the lady who was sort of the concierge and helping to enroll this trial and working with the patients who were enrolled and she was phenomenal. She helped me with scheduling. She helped me move from one department to another to make sure that I could come in on the same days. You know, not have to come in one day for the oncologist, you know, a different day for the urologist. And then, of course, the drug treatment, you know, that could have been a different day, but they coordinated everything so that it was extremely convenient for me, or as convenient as it could possibly be for me, I should say. You know, there were some days where the visits were rather long and everything, but still, you know, they have to do with what's in the protocol. So I understood that it was going to take some time from day to day on different days. But they did everything they could to make it as seamless for me and as smooth as possible. The way they provided the informed consent was really good. I mean, I knew about informed consent. I knew what the whole idea was. But they did a great job of describing, what the hypothesis was behind the study, what I would be going through, when my visits would be, what were potential side effects that I might experience. All those type of things and again, you know, they, they did a really great job. So I was, I was very happy overall with the the care that I received, not only from a clinical perspective, but from a customer service perspective.

Jimmy Bechtel 9:14

That's great, Jim. And it, it's that extra touch that, that enhanced level of customer service that we need to focus on. That's the takeaway I get from that. And it doesn't have to be, you know, not every site has that. Patient concierge or anything like that, but that's some service that we hope that our coordinators and some of the other research staff might be able to provide to our patients that are coming in and being participants in these clinical trials. So did you encounter then any roadblocks or challenges that were the result that may be in your perception of the sponsor or CRO facing aspects of the trial?

Jim Kremidas 9:51

No, I didn't, I didn't run anything there. You know, I don't consider this a negative comment, but the only thing that I found interesting was sometimes one department within the, the university hospital did not know what the other one was doing. So for example, and this again, no big deal, but you know, every place I went, they took my weight the same day. I'm like, it probably hasn't changed that much. And they, you know, and again, it's probably, it's probably a departmental SOP that, you know, but they do my blood pressure in each department each time too. So. You know, again, it's not a big deal. I just think it's interesting that as much as well integrated as this organization was, which, by the way, I thought, you know, I give them an A plus. There were still little things like that. You know, another one was waiting for the pharmacy to send up the study drug. they wanted to wait, of course, till the patient was checked in, but sometimes it took forever to get the study drug, you know, it seemed like forever. And, I kind of felt like once the patient checks in, they should start reconstituting that thing right away or start preparing it. So again, minor details, minor inconveniences. Overall, it was fantastic. But, that's about the only real issue that I had as a participant. One thing I wanted to mention, Jimmy, is, we always think of it as the study coordinator, which of course is important, but it's everybody at the site. It's the receptionist. It's the person who's scheduling your appointments. It's the first physician interface. It's the nursing interface, you know, the study coordinator, anybody that's working with that patient. Really needs to, in my opinion, be thinking from a customer service perspective and how they can make life easier for this person to participate in the trial.

Jimmy Bechtel 11:34

Thanks, Jim. I think there's a lot of critical takeaways for our site partners that are listening to this that they can bring back to their organizations and, and hopefully reflect on some of those internal processes. And like you said I really want to hone in on the, it's the little things that Or a little bit of a time waster, right? We get that different departments in different areas are taking weight, but you're right. Why can't we? Seems pretty simple in today's day and age to be able to share that information across the, the institution. So it sounds like there's some obvious areas of improvement. Are there any other areas of improvement that you might've seen at the site level that our listeners could take back?

Jim Kremidas 12:09

Again, not, not necessarily in the trial that I was in. I was again, very, very pleased with both the clinical and the customer service care that I received. So, I, I guess maybe the best thing I could say is, I think it's a good example of how good it can be. In other words I'm sure, we all as patients have had issues working through the medical system, you know, in hospitals and delays in doctor's offices and things of that nature. I, so nothing was really unusual in that regard. In fact, I felt like my care was better than I would have received had it been standard of care. And I think, you know, that's important because it, it, it gives people the opportunity as patients. To see that there's an alternative to clinical care and that's clinical research and you know, some people do it out of out of a strong unmet medical need. Some people are willing to volunteer just because they want to be altruistic and offer up the data that can be gathered from them for better scientific decision making and medical, better medical decision making. But,, the more you can help that patient feel valued, feel special, and, and make sure you're not taking away too much from their personal time, the better the industry is going to be. We need the volunteers. We need the patients. We can't advance science without it.

Jimmy Bechtel 13:32

I couldn't agree more, Jim. It's another great point that we need to make sure we bring home is that enhanced level, again, of customer service that we can bring to clinical trials as a differentiating factor from standard of care for these patients who are in a completely different place and someone who might be coming to just their doctor's office for regular treatment. So I appreciate you bringing that up and you know, I know that your clinical trial played a obvious significant role in your journey to becoming cancer free, which is a fantastic end point for you at this time. So congratulations there. And as you reflect on this experience, what advice maybe would you offer to patients who are considering or currently participating in clinical trials?

Jim Kremidas 14:13

Ooh, that's a good one. I guess the best advice I'd offer patients is ask questions because, you know, I really believe staff is more than willing to answer them in most cases. And if you don't ask the question, they may not know you don't understand or that you have a question, right? So I really believe that open communication between patients. And site staff, and that includes, again, everybody, the nurses, the coordinators, the doctors, et cetera I think that's really important because patients need to know what's going on and what to expect. You know, I had some very minor. Side effects, you know, you could call them adverse events, but they weren't that adverse. But there were little things that were happening to me and I, I brought him up with the doctor and he said, yeah, oh yeah, that happens often with this type of drug. And so, you know, that made me feel better. He said, you know, usually it's no big deals, it'll go away. And, you know, here's a little something you can put on it if you want. And, you know, that was the end of it. So. If you're having any questions, any questions about the study or how you feel while you're in the study, bring them up. You know, I think that's really, really important.

Jimmy Bechtel 15:26

It's a great tip, Jim. I think important for everybody to keep in mind, not only for our patients, but also for our sites to encourage and build a culture, build an environment for those patients to feel comfortable asking those questions because we oftentimes see that patients get intimidated or they're in a new environment. So they, they, they clam up. They don't think about the questions that they need to ask or raise the concerns that they need to do. So it's really important that we again instill that sense of comfort with the patients that are donating their time and you know, potentially their bodies and their, their health too. Making sure that we can continue our clinical trial. So again, great point there, Jim, we'll begin to wrap things up here. But in looking ahead, let's talk about the changes that you'd like to see in the healthcare industry and really the clinical trial landscape overall to ensure that maybe more patients have access to the benefits of clinical trials without some of the barriers that you've seen. And that you might have experienced.

Jim Kremidas 16:23

Yeah, well, one, there's several. So the first I would bring up is this whole concept of integrating clinical research as an option or an alternative to clinical care. And I know there's a lot of work going on about that topic in the industry today. And I'm really pleased about that because quite frankly, I wouldn't have been in this trial if it hadn't been for that type of an approach. I was receiving clinical care from a urologist who was well aware of what clinical studies were available, fortunately for me. And that's how I got into this trial. He knew exactly what the inclusion criteria were. And he knew that I fit them. And he immediately referred me to you know, the study and the oncologist conducting the study. So that's one. And I think that's, that's really the, ultimately the easiest and best way for a potential patient to get information about trials. It's from their clinician. So the, the other thing I think that's important is we need more, and I've said this ever since I've been at ACRP, we need more consistency in how site staff are trained. And how site operations take place, and I know that the operations parts difficult because there are so many different operations formats within the clinical care industry in the United States, but the more we can get consistency, at least. In our training of site staff, whether it's a study coordinator, a receptionist, a pi I think that's really important. I worry that sometimes the reason the quality of the data isn't good that come out of trials is because of inconsistencies. In terms of how various sites conducted the trial, and I know that, you know, the protocols can give you so much of a of a framework, but at the end of the day, you know, people work around the protocols to the best of their ability to stay within the protocol. It doesn't necessarily mean they're conducting the trial the same across sites. So, and I, it may be a bit of a provocative thing to say, but I really think consistency and training and, and career pathing too. You know, one of the things that we found at ACRP that really shocked me, I should say, it didn't really shock me because I already knew it. But when we, when the data came out. There are different titles for the same roles across various types of sites in the industry. So, you know, like a CRA, for example, at an academic institution is different than the CRA that we have at a pharma company. A CRA at a CRO may be different than a CRA at a pharma company. So that even the titles are, are different and there's not very much consistency there. So, you know, this is a relatively young industry if you stop and think about it. Really not that old. I mean, I was, you'll appreciate this. I was just up in Marquette, Michigan last week at the site where there was a a gentleman who accidentally got shot in the stomach and the doctor up there at the time, this would have been like an 1850 or something early, early on in, you know, in America's history, was able to track this patient, this, because it left a hole in the stomach. and actually figured out how the digestive system worked on account of this. This one individual and it was Dr. Beaumont is the guy that was the clinician, but that's, not even a couple of hundred years ago and we didn't even know how the digestive system works. I mean, and that was how research was done back then. You know, one patient with happens to have a hole in the stomach. And so we're going to monitor that. I mean, we've come light years. But it's still a relatively young industry, and again, I really firmly believe that consistency in across sites in terms of how staff is trained, developed, and assessed is really going to be important to move us forward into a system where we have consistency. Higher quality than we have today.

Jimmy Bechtel 20:33

Well, thanks, Jim. I think that's a great sentiment to end our conversation on and to leave us on here, a lot of really great takeaways and advice and, and really reminders for our sites in particular about what they can do to make sure that the patient experience is a positive one, some things to think about, I, you know, recollect on shaking my head as you were giving the answer around the, the, just the little things that. Although might not have been burdensome to you could be burdensome to others maybe that have difficulty with their weights or their height or something along those lines. So there's there's lots of opportunity there for us to take the patient or participant into deeper consideration during our clinical trial process. So thank you for sharing your experience with us. And thank you for sharing based on your industry knowledge, some context around what we can do to continue to To improve the process here.

Jim Kremidas 21:24

Thanks, Jimmy. I appreciate you you listening to me and letting me pontificate. It's a great industry and I love it.

Jimmy Bechtel 21:32

Anytime, Jim. It was great to have you. And thanks again for being here. All right, buddy. Thanks. Take care. For those that list for those that are listening, make sure you register for upcoming summits being held throughout the year by visiting the summit page on our website, my SCRS. org. While you're on our website, be sure to also check out other SCRS publications and resources built for our community in that same page, my SCRS. org. We appreciate your participation in today's program and look forward to having you join us for more great content coming out soon. Thanks again for listening.