Improving the Clinical Trial Experience for Patients by Leveraging Digital Technologies with Adam Samson, Director of Clinical Operations at Curebase: Audio automatically transcribed by Sonix
Improving the Clinical Trial Experience for Patients by Leveraging Digital Technologies with Adam Samson, Director of Clinical Operations at Curebase: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Saul Marquez:
Hey everybody! Welcome back to the Outcomes Rocket. Saul Marquez here, and today I’ve got the privilege of hosting the amazing Adam Samson. Adam is the Director of Clinical Operations at Curebase. He’s responsible for leading the clinical operations department inclusive of all clinical programs. He’s got a history of amazing work. Previously also lead clinical research associate at the Duke Clinical Research Institute, where he also served as Clinical Trials Project Leader. At Curebase they are focused around decentralizing that clinical research solution, getting drugs to market faster. It’s a fascinating platform. And I’m excited to learn more about it with Adam here on the podcast. Adam, thank you so much for joining us today.
Adam Samson:
Oh, well, thank you, Saul. Thanks so much for the introduction. Glad to be here.
Saul Marquez:
Yeah, you know, Adam, before we dive into Cubase and the work that you guys do around CROs, just talk to us about what inspires your work and health care.
Adam Samson:
Yeah, I’d be glad to. So I’ve had a lot of firsthand experience, like many of us. The impact of quality health care or, you know, sometimes the lack thereof and understanding that I’m very fortunate. But not everyone has access to quality health care even in this country and certainly around the world. And whether that’s due to cost being the prohibiting factor, geographics or, you know, we’re gaining a better understanding of just a lack of knowledge or mistrust of the health care system in certain communities. And what inspires me is making drugs and medical device development, the clinical research space more transparent, as well as cheaper and more widely accessible, and the development of medical interventions. They require clinical trials. So I’m inspired every day to find ways to conduct those trials more efficiently, more cost-effectively, ensuring that we have equity and diversity in trial populations and maintaining still the highest quality standards for data quality and patient safety.
Saul Marquez:
For sure. You mentioned a lot of really great stuff there, Adam. You know, the challenges with access, whether it be geography or socioeconomic, you know, getting these things to market. CROs clinical research organizations are really kind of going through a lot of change right now, especially with COVID. But even before that, there’s been a lot of movement around decentralized trials and how we move these trials to the home. And it’s becoming a reality with technology such as Curebase is providing. So talk to us a little bit about that. Adam, tell us how Curebase is adding value to the health care ecosystem.
Adam Samson:
Yeah. As you mentioned there’s just there’s a lot of change happening really quickly in this space. And you’re seeing, leveraging of technology. And that’s really where Curebase fits in. And we actually are partners with contract research organizations or CROs as well as sponsors to offer the most flexible solutions for decentralized trials that are out there. And I don’t know is all that helpful, perhaps for listeners, for me to kind of discuss a little bit of what a decentralized trial is for.
Saul Marquez:
Absolutely. Yeah. You know what? It’s worth diving in. Adam, let’s do it.
Adam Samson:
Sure. So I think a helpful way to think of it first is to start with contrasting decentralized clinical trials with traditional trials. Your traditional clinical trial would occur at a physical location. So that might be a large academic institution or hospital. It might be a small site, but nonetheless, everything has to occur at that physical location. So there are doctors and their staff, and a patient comes to the physical location and they’re screened for the study, they’re told about the study. If they want to participate, they have to come back to that location multiple times for a number of different procedures, depending on the type of study.
Adam Samson:
In a decentralized clinical trial what we do is rather than have everything occur at a central location, we take and make it such that most, if not all, of the activities, can occur remotely or at a place of the participants choosing. So, for instance, rather than having a participant drive to a research site, which, let’s face it, many people are hours from the closest research site, we can have our research coordinators at Curebase contact these participants remotely and walk through the process via video call the telemedicine, walk through what it is to participate in the clinical trial. They can complete the consent process and qualification. We can move in the doctor as well. And depending on the nature of the trial, if there are things that need to be in person, we can send a mobile phlebotomist or a mobile nurse to the participant’s house or a place of their choosing. So that’s what decentralized trial does. That takes the traditional model that requires participants to go places to a physical location, and it brings that trial to a place of the participants choosing. So you can have a fully decentralized trial or you’ll hear about hybrid trials now to where it’s kind of a blend of the two. And that’s where most of the decentralized trials are right now.
Saul Marquez:
Yeah, no, I appreciate that. That’s it’s good to level set on that. If you think about it, people have a hard time getting to the doctor to begin with. If you’re part of a research trial just to keep showing up and to keep showing up and then you have all of the geographic barriers that you mentioned at the beginning of the podcast, it becomes a challenge. Who you’re going to get to enroll and do I get to enroll if it’s something that I could benefit from? So and talk to us a little bit about how you believe what you guys are doing at your base is different or better than what’s available today.
Adam Samson:
Sure. Yeah. That is well into the prior question around how are we taking the DCT and adding value to health care and how do we do it differently? So, at Curebase, we offer both software and services. So our flagship offering is our Curebased software, where we have basically all the technology that you need for the participant, the doctor, the sponsors, and the CROs to conduct the trial. So e-consent and for folks who are familiar with clinical research, e-source, or the ability to collect data remotely, all that fits within the Curebase system. We take it a step further and we have services as well that align with that software. So that’s where my group and clinical operation sit. When it comes to things like project management and monitoring those data, as well as interacting with participants directly, our research coordinators, this enables recruitment and clinical data collection in any setting, whether it’s a local clinic or mobile care or any other different ways. So as you might imagine, this can help us do things more efficiently, more cost-effectively. Everything we had kind of mentioned at the beginning. Ensuring diversity because we can reach communities that otherwise really don’t have access to these types of facilities. And really the thing that we’re trying to do to add value and differentiate is to improve the participant experience more than anything else, make it almost enjoyable to participate in these clinical trials.
Saul Marquez:
Yes. So you guys have the software and the service to help with it. And I would imagine it’s something that becomes very useful when you have the knowledge. I mean, you spent a lot of time conducting these. So you know, you’ve been in the shoes of your customers that are using your services, and I’m sure you’re able to provide that much more value because of it.
Adam Samson:
Yeah, I think it helps a lot, you know, trying to take my background every day as a clinician and researcher within academia and pharma and tech to kind of re-envision what clinical trials can be, and most recently, actually, I was a participant in one of the COVID-19 vaccine trials, which was really enlightening for me to kind of be on the other side of the equation and see what that is like. And there were some really good things and some things where I thought, you know, do I really need to drive all the way in there and get a blood draw today? For me, it was only 30 minutes, but still, it’s about time you get out there and do it and you’re just trying to find a way.
Saul Marquez:
Three hours, right? Three or four hours. Did you have to spend it like that? Yeah, yeah. That’s awesome. And, you know, just thinking through this, like a lot of benefits can happen from decentralized trials. You mentioned diversifying the patient base. What are some of the other things that we could benefit from shifting from centralized to decentralized?
Adam Samson:
Certainly doing trials more efficiently and cost-effectively. Quicker. And I think that many of us saw how quickly, especially those outside of the industry saw how quickly the COVID trials were done and for vaccines. And it almost made people feel like they went too fast. But being in the trenches every day, what you find out is that much of the things that make it the average, you know, 10 years for us to get a drug from the bench or from the lab into the into patients is administrative burden and lots of just things that have to align with these things to happen. And when you have a community that’s using all the best technology and tools at their fingertips, it does allow us to apply the same level of standards for data quality and patient safety and just do things quicker. So, for instance, in a decentralized trial, the data that we collect, we’re collecting them in our Curebase platform directly into an electronic system. So typically back to the traditional model sites will collect data on paper generally. And then those the data that are collected on paper, even still the vast majority.
Saul Marquez:
That’s crazy.
Adam Samson:
I know.
Saul Marquez:
Sorry to interrupt.
Adam Samson:
Shocking. Yeah. So from that from paper to an electronic system. Now the paper is sitting at the site. So for the sponsor of the study, they have to, from a regulatory perspective, demonstrate that they have oversight. So they have to fly somebody, a representative to that site so that they can compare that data on paper match the data in the computer. So just that alone, you can imagine when you have a system where for Cubase, when the sponsor wants to monitor our data, they have our platform and their platform and everything can be done remotely. So it saves time, saves money, of course, because they don’t have to fly people back and forth so much. So just that’s one kind of example of how taking these types of these methods and putting them into practice can make things more efficient and more cost-effective.
Saul Marquez:
For sure. Thank you for that. And do you believe that the pandemic has helped accelerate the use of the decentralized model?
Adam Samson:
Undoubtedly, yeah, without a doubt. So the concept of decentralized trials is not new. It’s been over a decade since the first fully remote trial. There’s just been massive hesitancy from the industry. We’re highly regulated and the model has worked for a long time. And I think part of it too, the big players in the industry have been built around the traditional model and you don’t see a lot. Curebased, we started in 2017 and we’re purpose-built for decentralized trials. And I think that our CEO, Tom Lemberg, had some insight into the future there. And just we were lucky to kind of already have the system kind of built out when the pandemic hit so that we could know scale quickly. What you also see is tech companies generally focus on the software where large service providers focus on the services and we kind of differentiate by integrating one both under one roof. So it’s yeah, it’s good. Whenever you can kind of have that view across the study,
Saul Marquez:
It’s more seamless. Yes. You know, I mean, this is different. But I recently have a bookkeeping company and just for the longest time was doing my taxes with somebody else. And I’m like, why am I doing this? And now that my bookkeeping company does my taxes, it’s so much easier. They have everything they need.
Adam Samson:
I think the industry is really learning that sponsors and CROs are learning that, you know, they were a little concerned that FDA might not accept the data. Because the regulations are crystal clear and a lot of areas and there was also, I think, a concern around, you know, the ability to utilize these systems and with the pandemic did to your earlier point, it put us all in a situation where, you know, you can’t send participants to the site for this so it’s to the trial or use technology.
Saul Marquez:
This is so interesting. What would you say is one of the biggest setbacks you’ve experienced and a key learning? And it could just like the industry, that the industry of decentralized has experienced either or you could take it however you want.
Adam Samson:
Sure, yeah. I mean, for me, when the pandemic hit, I think we were all a bit, panicked in many ways personally and professionally in the pharmaceutical and drug development device development industry. Myself, I was at a large pharmaceutical company managing a global late-stage clinical trial that was in eight countries, three continents, 100 sites. And we quickly realized, as many others did, that our study protocols just weren’t really developed for anything like this. I mean, who could have foreseen this? Yeah, so we still have a lot to learn as an industry. We’ve been kind of thrust into this. I think that we’re fortunate that we have the technology available. It was just a matter of leveraging it. So we were fortunate there. This was, you know, 10, 15 years ago. It would have been more difficult. Yeah, for me, I mean that as a setback is ultimately what led me to leave a large safe job at a pharmaceutical company to join a small startup technology company. Couldn’t be happier that I did.
Saul Marquez:
Is it because you just saw it? I mean, we were in the middle of it and you’re like, there’s no way we can’t be doing this?
Adam Samson:
Exactly. Yeah. You know, it was something that I already had glimmers of, of course, in the industry, you realize like banking and other industries are doing this, right. We had a hard time even using electronic signatures. So that was kind of the moment for me when I realized there are other ways to do this, more people that are going to work on these hard problems. And I want to kind of be part of that.
Saul Marquez:
Good for you. That’s fantastic. You went for it.
Adam Samson:
I did, yeah.
Saul Marquez:
And now you’re working on it. And it’s so exciting to hear your enthusiasm for the promise of decentralized trials and what they could do for cost, lowering costs, what they could do for time, decreasing the amount of time that it takes in the overall involvement of all parties, but also time to get a drug to market. Just the ease that that could be accompanied with is hugely promising and I’m sure takes out a lot of costs, too of the in the pharma value chain through everything that your you’ve done and what you’re doing now at what would you say you’re most excited about today.
Adam Samson:
So, I mean, a big part of it too. I mean, it’s super exciting. And to see it across the industry. So there’s a new group called the Decentralized Trials and Research Alliance that Cubase is a member of. But we are a member among more than a hundred members now that our pharma companies, tech companies, CROs, multiple stakeholders, sites that get together. And we are trying to standardize what it is, what the definitions are, and what best practices are. Part of Curebase is contributing to the clinical trials transformation initiatives. It’s also looking at solving some of these things as well. So just pulling together as a community of professionals. But also, you know, it’s exciting that clinical trials are dinner table conversations. When I would say I worked in clinical research. People really didn’t understand. And, you know, it’s I think it’s contributing to an increase in public trust and again, increased options out there for clinical trials and increasing diversity in clinical trials and trying to make that participant experience enjoyable and something that really helps us to get medical therapies to the market quicker.
Saul Marquez:
Yeah, that’s for sure. It’s very exciting. And you’re right. I mean, it is commonplace. And honestly, I just go back to COVID and you like it’s the thing that put a lot of topics such as telemedicine, virtual care, how we come out with these medicines, you know, the trials front and center. So it’s certainly an exciting time to be involved in and also thinking through the work that you and your team at Curebase are doing. You know, for the listeners that want to connect with you and the team and learn more about how they could use you guys or learn from you, what would be the best place that they could reach out.
Adam Samson:
So definitely curebase.com. C U R E B A S E.com. to learn more about Curebase, but listeners feel free to reach out to me personally. Adam@curebase.com. I’d be glad to answer any questions you might have or find ways to collaborate. So, yeah, any time.
Saul Marquez:
Love it. Adam, I want to thank you again for visiting with us. This is really interesting and informative and we’re looking forward to hearing how you guys continue evolving this space. And I really appreciate your leadership here.
Adam Samson:
Thanks so much, Saul. And thanks, everybody for listening.
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