What clinicians need to know about clinical trials [PODCAST]

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“Before COVID-19, clinical research was a little-known part of health care. Despite this process being responsible for determining the safety and efficacy of all the drugs, medical devices, vaccines, and other medical therapies available, less than 5 percent of the U.S. population actually participates in clinical research.

One reason why clinical research has little awareness and even lower participation is that, unlike other major industries, the pharmaceutical industry and many regulatory bodies never fully embraced technology to reduce the burdens of participation. We use our mobile devices to do our banking and place retail orders. Why can’t we use similar technology in clinical research?”

Kent Thoelke is a science executive.

He shares his story and discusses his KevinMD article, “Accelerated by COVID-19, technology carves new pathways for everyone to access health care.”

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Hosted by Kevin Pho, MD, The Podcast by KevinMD shares the stories of the many who intersect with our health care system but are rarely heard from.

Transcript

Kevin Pho: Hi, and welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. My name is Kevin Pho, founder and editor of KevinMD. Today on the show we have Kent Thoelke. He is chief innovation officer at ICON, and he wrote the KevinMD article “Accelerated by COVID-19, technology carves new pathways for everyone to access health care.” Kent, welcome to the show.

Kent Thoelke: Hey, thanks, Kevin.

Kevin Pho: We’ll get into the article in a little bit, but first off, can you share your story and journey to where you are today?

Kent Thoelke: Sure. I started in bench research about 35 years ago and thought I wanted to be a biochemist, and I spent about six months on a bench and realized the lab science was a really bad thing for me. I was with a multinational company and got offered the job to move into clinical development, and really just expanded my career from there.

I spent a number of years in small and emerging biotech companies, creating some novel therapies for patients. Back in those days, it was really early days for clinical development. The FDA really didn’t have a strong framework, and so it was a little bit of the Wild West, but we were getting all sorts of novel medications to patients that really, for a long time, didn’t have adequate care. And so that really started my journey.

I moved into global contract research organizations after that and spent about the last 15, 20 years really focused in that space. That’s working with a multitude of pharma and biotech clients around the world, as well as physicians and their practices, to get clinical trials out to as many patients as possible, depending on the disease state. And I would say that likely in the last decade I have really spent most of my time focused on patient centricity and how we expand access, both to patients but also to physicians, so that we can make clinical research a care option for all patients, as opposed to the minority of patients. That’s really been where my passion lies today: How do we get more patients access to better care?

Kevin Pho: So I’m an internal medicine physician, and the majority of this audience are practicing clinicians. Now, what are some things about clinical trials that practicing clinicians need to know, but a lot of them don’t?

Kent Thoelke: I think the first thing is just knowing that they’re there. The majority of patients out there get standard of care. The majority of clinicians in the U.S. and around the world are not in major metropolitan cities, so their knowledge of and access to trials is limited. So we have kind of two challenges. One, the pharma and biotech companies and CROs really need to place studies with clinicians that are in probably non-traditional areas, rural areas, non-academic or major medical centers.

But the other thing is that physicians need to really spend some time on their own exploring what trials are available for their patients. There are lots of resources out there. ClinicalTrials.gov is probably the major resource out there, where physicians can search for their patients by disease state, by inclusion criteria, etc.

I think most physicians are probably turned off or concerned that the volume of work involved in participating in a trial is quite high. I think we have really worked hard in the industry to make it more streamlined, and so I think that physicians just need to take that first step. But really, the first thing is just doing your research to understand what’s available and out there for your patient based on their disease.

Kevin Pho: Now, in general, what specialties of medicine are clinical trials most available to?

Kent Thoelke: Everywhere, everything. I think that originally, clinical trials back 20, 30 years ago really focused on patients that were at their last-ditch effort, just throwing anything at them to try to save their lives. So in diseases that were acutely terminal, many of them oncology and rare diseases, you would see patients offered clinical trials as a last effort.

I think what we’ve seen over the last couple of decades is that this has really moved up in the paradigm. Where therapies may have been third or fourth line for patients, really today most of them are add-on therapies to first or second line. We still certainly do trials in patients that have failed all other approved therapies, but that model has really changed. And so when we think about best possible care, when we think about clinical research as a care option, trials have really moved into the forefront.

So for really any patient, by any disease state, there is likely a trial out there. I think what the physician needs to do with the patient is really assess whether or not that trial is the most appropriate option based on disease, mechanism of action, where they are, lifestyle, expectations for how they care for themselves, and what kind of care they have. So it is, I would say, a multifactorial discussion, but really every disease is out there today.

Kevin Pho: You did mention that it required a little bit of work to include a patient in a clinical trial. I actually don’t know too much about that, so just give me a sense of what kind of workflow is needed to include a patient in a clinical trial.

Kent Thoelke: Well, of course, safety is paramount. All clinical trials are regulated by various regulatory bodies around the world. In the U.S., it’s the FDA. In Europe, it’s the EMA. And there are regulatory bodies around the world, country by country, that really focus on the protection of subjects that participate in trials.

As a part of that, like with everything, there are forms to fill out. Physicians have a number of regulatory forms that need to be filled out that make sure that they’re licensed and educated and agree to control the patients in the trials. We check for things like lab certifications and a lot of the rote things that they do anyway, but likely don’t have documented somewhere systematically, and so we have systems set up for that. The support network, when a physician participates in a trial, can help them do all of that to make it a little bit easier, but there is some administrative work on the front end.

The second piece is that most of our clinical trials are quite defined. The inclusion criteria and the exclusion criteria for who can participate in a trial are well scripted, and so it takes a little bit of effort for physicians and their staff to really go through charts and find patients that match appropriately for a trial. And then, once that’s all done, it’s really taking the time to explain to your patient what participating in the clinical trial means and the potential value to the patients and the broader patient community.

So there is some extra time involved, but I would say that the benefits far outweigh the extra burden, for the patients and for the physician, for what they can offer their patients.

Kevin Pho: All right, so let’s transition into the KevinMD article that you wrote. This was back in March. It’s titled “Accelerated by COVID-19, technology carves new pathways for everyone to access health care.” Now, for those who didn’t get a chance to read that article, can you just walk my audience through it and share the story of why you decided to write it?

Kent Thoelke: Sure. When COVID happened, almost overnight, what, 15 or 16 months ago, with concerns around infection rates with COVID, physicians, medical centers, and hospitals really limited access to patients coming in physically to these hospitals. What that meant for patient care, and certainly for patients on clinical trials, was that very rapidly we had to figure out a way to deploy these medications to these patients remotely, but then also continue to monitor those patients effectively, to ensure both safety and that we could monitor the new drugs in testing for efficacy.

Simultaneously, what we saw across health care systems around the world was this shift, where possible, to moving patients into a telehealth, telemedicine, remote patient monitoring modality. Where practices could, if they already had technology that allowed for remote monitoring or telehealth, they implemented that for many of their patients.

For clinical trials, we had to simultaneously adjust. Most of our trials did not allow for telemedicine or telehealth or remote patient monitoring. So simultaneously, where health care systems were deploying these methods, we integrated them into the clinical trials, so that how we were conducting the trials matched how health care was being delivered. In many health care systems, we saw uptake of 1,000 percent, 2,000 percent. So where you had massive patient populations who were coming to the clinic for all of their experiences, they were now being treated at home, either remotely through telehealth or through home health care nursing.

And so what COVID did was escalate something that we had thought was very important for a long time. What we knew was that in the U.S., as an example, only 3 to 5 percent of eligible patients participate in research. Much of that is access issues. It is complex for patients to participate in a clinical trial. It requires more effort to get to the clinic or the physician. It requires significantly more hours in time to do scans and labs and things like that.

And so for quite some time we knew that if we could make access easier for patients, if we could lower the burden for patients, then we would allow more patients to participate. What focused that was really decentralizing clinical trials through the use of these technologies. And so COVID allowed us the impetus to move not only health care but clinical trials into a more technology-focused space, to allow patients to participate in research from wherever they are.

Kevin Pho: Can you tell us a story, or paint us a picture, of a specific clinical trial or drug that was administered using some of these remote technologies that you just described?

Kent Thoelke: Sure. I think there are two examples. Generally speaking, in rare and orphan diseases, patients live very far from potential clinics. Those patients have little to no access to clinical trials in the current model. The treatment paradigm we had is that many of those families and patients had to transport their children, as an example, with an orphan disease, several states away just to get access to potential care. And so for many of those trials, we started deploying remote monitoring technologies, in-home health care nursing, telehealth, and telemedicine in the last couple of years. So they were really on the forefront of many of these technologies.

But then, fast forward to COVID, we participated in a fully virtual clinical trial in heart failure. In that case, patients really never saw their physicians. All of those patients were enrolled via health care systems, via a mobile platform. They were consented electronically. Their medication was shipped to them directly. We sent them devices to monitor their health care remotely, which was centrally monitored by the physician who led the study, and all that data was collected remotely.

What was fascinating about that study, and we talked about access, is that the number of patients that enrolled was significantly larger than in a normal heart failure trial. In some cases, we saw enrollment 10 times faster than we would in a normal clinical trial. But what was most exciting, and what we saw with COVID, is that equity and access to health care by minority populations was significantly increased when we used that model. We saw a broad range of diversity in those trials, upwards of 30 percent, where most of our trials probably only have a diversity quotient of 2 or 3 percent.

So both of those trials really show that when we include these technologies, when we allow patients to have some access to their physician remotely, we can do clinical trials better and more efficiently.

Kevin Pho: We’re talking to Kent Thoelke. He is chief innovation officer at ICON, and he wrote the KevinMD article “Accelerated by COVID-19, technology carves new pathways for everyone to access health care.” Kent, hopefully we’re entering the tail end of COVID now. Do you see any of these remote technologies persisting going forward, even after COVID ends?

Kent Thoelke: Our hope is that many of these things stay sticky. I think what will manifest that is really reimbursement. What we saw with groups like CMS and insurers was that, during COVID, many of these things like telehealth and telemonitoring visits were not reimbursed at the same rates as a traditional visit. Many of those things were changed during COVID, so that physicians could participate in these types of technologies and still get reimbursement for those visits. I think it will remain to be seen whether or not those types of reimbursement approvals stay in effect. If they do, I think we have a much better opportunity to continue to see stickiness of these technologies.

I think the other thing to remember is that health care is changing. Access is changing. The requirements for physicians, the time needed to see patients in clinic, are changing. What telehealth and telemedicine and remote patient monitoring did was give physicians a lot more access to their patients in real time.

And so we’re hoping that remote patient monitoring, as an example, becomes more mainstream, because I think that physicians who can more constantly evaluate a patient’s disease provide better care as well. If you think about a patient that has a chronic disease, those patients may only come in once every four, six, eight, or 12 weeks, depending on their disease state, and in those in-between periods, physicians are really reliant upon a patient or a caregiver for recall: “So how did you feel the last couple of months?” And what we know about patients is that they’re really poor at recall.

And so if we can monitor those patients in real time during those empty periods, when they’re not in clinic, and collect that data and provide that data to the physician or caregiver, it just gives them more information to provide better diagnostics, better care for those patients, and a better understanding of how their medications are treating their disease state. That all dovetails into how we do clinical research as well. And so I really am hoping that physicians take this opportunity to leverage those technologies in their daily care for their patients, because I think that it just provides better care.

Kevin Pho: No, other than the reimbursement piece that you mentioned, what are some of the other obstacles that are preventing more clinical trials from including more remote technologies when it comes to garnering more applicants?

Kent Thoelke: Well, I mean, health care systems that are very large, that have their own chief information officers and IT departments and technology deployment groups, do better because they have the infrastructure and support. So I think we will see widespread adoption in those major metropolitan cities and locations where hospitals have that infrastructure, where big clinics and tertiary medical centers have that infrastructure, because you need that to do it.

I think for smaller practices it’s going to be more of a challenge. I think they’ll need to align themselves with national groups, the national telehealth providers that are out there. I think it’ll be a little more of a challenge for them. So I think that the adoption of the technology is probably the biggest barrier, because there is some investment required, but I think that that will vary.

I think my concern is probably where the need is the greatest. In rural communities, or spaces where patients are a couple of hours from the nearest care, they are probably the last groups that will get access to these opportunities unless we focus on that. And that will require major medical systems, health care systems, to really expand their investment and outreach into those communities, beyond the traditional metropolitan markets.

Kevin Pho: And my final question: What’s your take-home message that you want to leave with the KevinMD audience?

Kent Thoelke: I think the take-home message is that clinical trials and drug development provide patients options that they otherwise wouldn’t have in standard of care, and in many cases that care is better care. When you think about trials that are very close to approval, there are medications out there that, based on disease state and based on mechanism of action, have a high likelihood of impacting a patient’s quality of life, or their longevity of life, or their disease state.

And so the take-home message is that I really want physicians to take the time to educate themselves, look at the clinical trials that are out there, ask the questions, and reach out to whoever’s sponsoring those trials to see if they can potentially participate or get access to their patients for those trials. Because what we would like to do is make clinical research a care option for all patients, and not just the few patients that happen to be in the right place at the right time.

Kevin Pho: Ken, thank you so much for sharing your time and insight, and thanks again for being on the show.

Kent Thoelke: Thank you, Kevin.

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