Outsourcing-Pharma (OSP) discussed the intersection of clinical care and healthcare with John Potthoff, CEO of Elligo Health Research, on how decentralized trials have progressed, and what trial professionals can learn from the healthcare industry.
OSP: Could you please share your perspective as an industry expert on the evolution of the clinical trial industry in recent years?
JP: Over the last few years, what we’ve seen is a great attempt at trying to solve some of the fundamental problems of access to patients for clinical trials. The industry has been struggling with how to get people involved in clinical trials, and at the same time we’ve had fewer and fewer physicians conducting clinical trials.
It’s part of what I call the complexification of the process. The efforts to help bridge some of the gap of getting more patients involved in a clinical trial when you have less access are almost causing the problem.
This really originated as the industry started to shift more toward precision treatments. Not everybody who has a condition qualifies for a specific trial anymore, and medications are starting to be more tailored to subsets of groups.
If a Starbucks said, “We found the perfect coffee for left-handers, but now we need to sell it to as many people as we used to that are both left and right-handed,” it would get difficult.
This is the same thing—it’s a geographic business. People are only going to drive so far for coffee. The same is true for a clinical trial.
If you start looking for more and more subsets, first of all, you have to have more locations, and you have to have more physicians doing it. Then, for the physicians that are doing the trials, if they’re used to enrolling 20 patients on a study, and now are only going to get 10, that means they have to do twice as many studies in order to maintain their business and their infrastructure.
If they can’t do that, then they’re trying to maintain an infrastructure they can’t really support. It’s driven people out of the industry on a small basis, so you have less and less access to research that’s done alongside healthcare, because can’t afford two infrastructures.
On the other hand, another big trend is the advancements in consolidation, and the technology enhancements of healthcare. Healthcare has made a lot of gains and has learned a lot about how to delivery healthcare to different communities, different geographies, different types of patients; there’s been more variety there.
It’s by no means perfect by any stretch of the imagination, but healthcare has changed dramatically. We really haven’t adapted our model of clinical trials to the way that healthcare is delivered today.
We have this big disconnect, and thus there’s a lot of interest in what we can do. It’s a lot easier for us to stay more responsive to patients and physicians if we really adapt what we’re doing in research to the traditional patient journey in healthcare.
That’s where we see a lot of innovation, especially in the last five years, that has really driven toward companies and approaches of looking at how we can look and learn and adapt and have a better outcome by doing the same things that are happening in healthcare, and utilizing some of the tools and technologies that are available in healthcare to help patients have more access to clinical trials and to help physicians have more access to clinical trials.
OSP: Specifically, how have adoption of and attitudes toward decentralized trials shifted? Also, how has the COVID-19 pandemic impacted the evolution of decentralized and hybrid trials?
JP: The industry is still struggling to figure out what it means. I think that it means something very positive. We’re really trying to get more directly able for more patients to participate, and not be restricted by a formal regulated site network.
There are different models of decentralized, where it’s direct to patient and the patient navigates their way through the trial. Then there’s decentralized through healthcare.
It’s interesting. You’re decentralizing the physician but you’re centralizing the control and the conduct of the trial. I actually don’t think that I’d call it ‘decentralized,’ but I didn’t get to vote on it.
The opportunity exists today and I think we had demonstrated some of this with some early adopters, being able to get out and, pre-COVID, show that with a centralized PI and control layer, you can interact with patients and contributing physicians, and execute a controlled clinical trial that way. Instead of having 40 sites enrolling 10 patients to get to your 400, you could have 400 doctors enrolling 1 patient, and still have a controlled clinical trial that had more access in it and conducted much, much faster.
I think the trick to a decentralized trial is still, How do you interact with healthcare? There are trials where you don’t need as much healthcare, but then you sort of go up the scale, like “Can I send nurse to their home to draw blood?”
As you get into more complicated diagnostics, it gets more difficult. It’s really difficult to do your own at-home biopsy, or do your own endoscopy; when you try to get the patient to be their own navigator of healthcare, that’s hard to do.
As we’re seeing decentralized trials starting to get in, and you’re seeing things called hybrid, it’s really about how do we centrally control and assure compliance and safety and all of that around a clinical trial while enhancing the number of physicians and patients that can participate in it through healthcare. It’s incredibly aligned with the mission and the discussions and everything that goes on with the CRAACO conference, and the whole idea of clinical research as a care option is doing that.
I look at it as it’s sort of like Airbnb. It’s hard to turn your house into a hotel unless you have an infrastructure that makes it work, organizes the contracts so you don’t get sued, all that kind of stuff. That’s really a lot of what we’re doing here—we’re realizing that healthcare has the knowledge, they have the equipment, they have the training.
Pre-COVID-, this was an oddity. Some companies we would talk to would say,” We want to do this, we’re really innovative,” and we would even be talking to the innovation groups at companies, and they would say, “We want to do innovative things, but first show us it works.” I’d say, “Well, okay, but that’s not innovative.” There was a lot of that happening pre-COVID, “I want to do this but only after it’s been proven 10 times.”
All of a sudden, once COVID hit, everyone got really comfortable with remote monitoring; they had to. We’ve been able to show that it adapted. As people have adapted and are starting to work on trials that are ongoing now in our post-arrival-of-COVID world, we’re seeing that people have not only adopted the idea of a decentralized trial, they’ve leapt ahead.
Pre-COVID we would get calls and I would start describing, and they’d say, “I’m interested in doing a decentralized trial, and we would spend some time talking about it. Now, people call and I say, “Let me explain to you what a decentralized trial is,” and they say, “I understand what a decentralized trial is—can you do it in the US, France and Korea?
It’s nice, because regulatory groups have been way ahead of industry on this. It’s been interesting to see industry catching up to regulation, which is not always the way it goes.
OSP: Your presentation is entitled “A Decentralized Trial Conducted Within Healthcare.” [November 6, 9:30 am EST]. Can you give us an overview, and share why this topic is an important one?
JP: I think what was really important was being able to show and to demonstrate we can conduct trials that require healthcare, and we can do it individually through patients, and manage that in a way that not only saved tremendous amounts of time and cost but that also yielded better results. We had more control over enrollment to make sure we were filling the right cohorts, we had better distribution, we had a much better representation of different populations of patients, we had a lot of great diversity in the trial—that was one of the goals. It showed that when you’re able to go in and run a trial that you’re controlling in real time and have lots of access, then following the processes of healthcare, you can really do things in a much easier way.
This was not an overly complicated trial by any means, but it really demonstrated all of the different aspects that need to happen in order to conduct it, gather the information, do it in a controlled way, and to get to the answers faster. The faster we get to the answers, the faster we can get new treatments to patients.
OSP: Could you talk about how decentralized trials can lower costs and decrease time to complete clinical trials while increasing quality?
JP: Decreasing time basically means that you’re not restricted on a flow of patients through a small number of sites. It is theoretically possible that you can enroll all your patients on the same day. It’s about how much control and process that you have around that—scale and access to patients turns into not the problem.
We know the patients are there, we can access them. It’s about having the workflow the ability to process everything, and to control, and manage, and make sure you’re executing properly. That becomes your biggest issue, but you can mobilize and work through this. Because you’re doing that, it dramatically improves timelines.
Time is cost in these trials. The trial that we ran came in at 80% less cost than a traditional model. Because you’re really managing things in real time, you’re able to affect. We got the quality of our enrollment to match the cohort of patients spot on. It was designed in a way that we had great access to diversity of patients.
We were able to manage the data flow as it was happening in real time, so that we could take any corrective actions in real time. Bringing that line closer yields better results. Nothing works as well if you’re auditing it afterwards. The longer that you are coming in and running the trial afterwards makes it harder.
OSP: Could you talk about a decentralized trial that involved engineering complicated procedures within healthcare?
JP: When you’re doing trials direct to patient, and they need to do something—in this case, they needed to have colonoscopies--it’s being able to make sure you’re not dropping that onto the patient, but facilitating. One of the worst things we can do to a patient in a decentralized trial is take all the things that they would have received at a site, where they’d come in and get labs, they’d get a screening, a diagnostic test, and things that you’re not going to do at home, is to then send them driving around town for two days trying to get all those things done. That’s just not the right way to do it.
Being able to show that we can do those things, and make it efficient the patient and make them have a great experience is really important in a decentralized trial. There are trials of increasing complexity where we are able to mix working directly with patients and integrating with healthcare.
OSP: Also, please tell us a bit about designing appropriate recruitment campaigns to accelerate a decentralized trial.
JP: One of the important things as we go is looking at who are we really targeting for trials, and where on their healthcare journey are they really ready to make a decision about being part of a clinical trial. It’s really important as we look at patients who flow through healthcare is that we get them at the right point.
Where is the right point to get them? Do you get them while they’re at the point of a specialist, or do you get them before they’re going to the specialist, or somewhere in between?
This trial was a great example of how getting them at the specialist was too late. They were already on a path, and once they’re on a path, it’s hard to divert people off a path. It was much more important to get them earlier.
We look at the right point in time to do that, and then set up the way that we’re recruiting so we can attract the right people into the right cohorts and manage that in a centralized way. We really want to have the right diversity of participants.
Elligo Health Research is lead sponsor of CRAACO 2020, a virtual online event (scheduled November 4-6) focused on sharing trends discussing solutions around clinical trial as a care option. Visit bit.ly/3kBUce5 for more information.