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Let’s Get Honest About Decentralized Clinical Trials
Episode

Hassan Kadhim, Global Head of Clinical Trial Business Capabilities at Bristol-Myers Squibb

Let’s Get Honest About Decentralized Clinical Trials

Brought to you by   | hosted by Joseph Kim

 

Let’s get honest about what decentralized clinical trials are before this bubble bursts!

In this episode, Hassan Kadhim, global head of clinical trial business capabilities at Bristol-Myers Squibb, takes a very sober look at decentralized clinical trials: what they mean to him, how they are evolving, and what it means for them to take hold. To incentivize progress around DCTs and their methods, Bristol-Myers Squibb came up with a definition for the term “decentralized clinical trial” that enlists four traditional capabilities and four up-and-coming ones, all of which Hassan explains. He discusses the design and coordination for the implementation of DCTs to collect the necessary patient data in a comfortable, low-burden manner. Though not all countries, organizations, or sites are ready to implement DCT methods, COVID has certainly pushed the industry towards them.

Tune in to this episode to hear more about DCTs from Hassan and learn where they’re taking the research industry!

Let’s Get Honest About Decentralized Clinical Trials

About Hassan Kadhim:

Hassan is a multilingual professional with 15+ years of experience with informatics & digital technology in the pharmaceutical/biotechnology industry. With university degrees in Bioinformatics and Clinical R&D, Hassan has a great mix of pharmaceutical industry Drug Discovery and Clinical Operations knowledge and Informatics. He has contributed to driving forward the vision of patient centricity and digital health at BI by promoting the Remote Clinical Trial model and implementing several innovative digital health technologies in Clinical Trials to drive Patient Centricity. A great communicator with superb interpersonal skills, Hassan regularly interacts with key stakeholders to provide innovative solutions to critical problems. He is highly motivated in constantly seeking to improve processes and efficiency while driving innovation and acts as a key contributor to multiple projects. Over the years, he has developed experience working in a global organization that requires collaboration with multidisciplinary international partners and is a guest speaker at several global Pharmaceutical and Clinical R&D conferences. Hassan is an active contributor to Transcelerate and the Clinical Trials Transformation Initiative (CTTI).

 

Research Confidential_Hassan Kadhim: Audio automatically transcribed by Sonix

Research Confidential_Hassan Kadhim: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Joseph Kim:
Welcome to Clinical Research Confidential! On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health. But it’s not for the faint of heart. And so on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry, now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
Hi everyone! I’m here with Hassan Kadhim. So I’ve known Hassan for, gosh, a long time now, years, and it’s really great to have you on the show. For those of you who don’t know him, he is the global head of clinical trial business capabilities at Bristol-Myers Squibb. Welcome to the show.

Hassan Kadhim:
Thank you, Joe. Great having this conversation with you.

Joseph Kim:
Yeah, So today we’re going to talk about decentralized clinical trials, and this has been pretty hyped up for some years now, And I really want to work with you to get down to how you really define it, because you seem like the type of person who probably hasn’t like drank too much of the Kool-Aid, but of course, we can’t, we want to innovate as well. So that’s sort of the topic for today, but before we go into that, I want to talk a little bit about your own story in clinical research. So judging from your background, you know, you didn’t go to school for clinical research, you went for like bioinformatics and it was, and you started out more in the IT world and basic science. Tell us a little bit about that origin and how you ended up where you are.

Hassan Kadhim:
Yeah, sure, so yeah, I did my college years and started in IT, then pivoted more to the science and the bioinformatics, and I actually did my graduate studies in pharmaceutical sciences with a specialization in clinical research, so that last part really is what got me the basics of clinical research. But when I started my career in the industry, first in small biotechs and then into early, the early R&D space at Boehringer Ingelheim, where I spent 11 years of my career before moving to Bristol-Myers Squibb, I was always, as I started in the early R&D space, I always felt there’s something missing. It was very abstract, we’re working with compounds and cells and you don’t feel the impact on people until much later down the research process, and that has always left a desire in me to look on the other side. And eventually, an opportunity came and I jumped on it and started working on the, in the clinical side. And while I was completing my graduate research where I focused on, in fact, on what at the time we called the remote clinical trial model, that’s before it was called DCT, I found this world very fascinating and I continued working in it until I got the opportunity to join BMS and lead the Clinical Trial Business Capabilities Team, which is a really nice blend of clinical trial expertise and digital health technology expertise. We blend both and really drive the strategy for BMS global development operations in how do we advance clinical trials using digital technologies. So we cover the entire spectrum of technologies from your established bread and butter clinical trial technologies like CTMS, ETMF, EDC, and so on and so forth to the new up-and-coming and let’s say exciting innovative capabilities like decentralized trials and digital protocol solutions and things like that. So I lead a team of about 30 and focused on strategic initiatives and always looking to improve on the way we conduct trials both at BMS and in the industry.

Joseph Kim:
Yeah, great, great. So then what part of your job is really focused on doing things kind of the traditional way, which let’s face it, isn’t going to disappear overnight, maybe never disappear for good reason, versus what percentage of your time is focused on novel innovation?

Hassan Kadhim:
That’s a great question. So I lead the group and obviously for those parts of the business that are established, we have experts in our group that drive the operations of the established capabilities. So I do get involved in there to make sure things are working to ensure we continue developing the strategy, but I spend maybe 30 to 35% of my time there, whereas the new up-and-coming technologies and capabilities are fertile ground. We got to build it from the ground up and requires a lot of thinking, a lot of strategic focus, and this is where I work a lot with both with my team and adjacent team stakeholder teams to really build strong capabilities, especially for the new ones. There’s not a lot of experience out there in insights, so we really got to do some research internally, we have to reiterate several times to see what works and how we can really establish that capability for long-term success, and that’s why I would say it’s been about 60% of my time.

Joseph Kim:
Wow!

Hassan Kadhim:
Yeah.

Joseph Kim:
Now, is it because it’s that much harder or you love it, you like it better, or is the other stuff just kind of run on autopilot?

Hassan Kadhim:
Yeah, it’s probably a bit of both. So I definitely like it. I like the totality of my role, but there’s a bit of excitement on the innovative capabilities. But I can tell you, it’s not just that, there’s definitely a need because a lot of people get excited and hyped about everything that is new, but when you get down to doing it, we stop. And that’s why a lot of innovations, especially in this industry, take a long time before they realize. There is, people underestimate how much, I mean, they get excited about it by innovation, but they underestimate the effort that it requires to stand this up, especially in clinical trials, which is a very risky business, which requires a lot of scientific and operational input. And any mistake you make in that space could cost you a lot of money down the line and could be, could jeopardize future revenue potential, which is why people are really careful. And that’s why we, I personally invest a lot of time to make sure that what we deliver to the organization is not only fit for purpose but takes into consideration all the risks that can come with implementing something new.

Joseph Kim:
Yeah, I mean, simply put, I like to say you never want a good drug to look bad because something got screwed up, and maybe worse, you never want a bad drug to look good because you screwed it up and you know the data is, the quality wasn’t there. So the stakes are very high, as you said. So, yeah, let’s transition to this topic of decentralized clinical trials, which, you know, I think if you asked five people, they’d give you five different definitions. And all of a sudden in the last year you have these companies who say, oh, we’ve done 1000 decentralized clinical trials, which is technically impossible. And what they’re doing is they’re saying, well, we did this one thing remotely, so I’m calling that a decentralized clinical trial. What, can you please clarify, from your vantage point, like what to you is really a decentralized clinical trial? Is it one procedure that’s done at home or is it everything or something in between?

Hassan Kadhim:
Yes, so what I find interesting is how we’ve evolved as an industry, certainly catalyzed by the pandemic. But I remember when I was doing my graduate research thesis in 2014 and just really introducing concepts like remote trials, people were not fully aligning behind that. They would think this is totally futuristic, you can’t do it. And the definition of it at the time, of course, did not stick with people’s minds. It was really interesting observing when the pandemic hit suddenly everybody realized, oh, that actually not only works, but we actually need it, it’s not just exciting, it’s something we absolutely need. And suddenly everybody started defining it in their own way. And then on top of that, that created a huge hype cycle and everybody wanted to join that bandwagon. So you started hearing that term, and I get tons of emails from vendors, collaborators, people that want to showcase their product, and decentralized trial, that term is always there. It’s like, you want to capture someone’s attention, put that term in there, they’ll read the email. So we got into a situation where the term is used so much that people don’t really know what it means anymore. They just know that it’s important, it’s exciting, and it might get me somewhere. On the flip side, when as a pharma company, you’re trying to develop that as a capability and you’re looking for partners, it becomes really difficult because all these vendors have different definitions for it, and then there’s new vendors that come in that space and they also claim to have that. So when we, obviously we were impacted by COVID like every other big pharma, and we, that became a catalyst and impetus for our leaders to agree that we need to do something big about decentralized trials. So it’s a partnership with many different stakeholders, certainly my team as the business strategy function, but there’s no doubt a need for partnership with IT as the technical integrators and kind of the technical shepherds of the system and with our procurement colleagues who help us build these commercial partnerships with several vendors. So as we got together to define what that thing is, we considered several approaches. And first of all, we wanted to make sure we internally are aligned on what that means, what are the basic components of what we call decentralized trials. But then we wanted to ensure that what we make, what we internally mean is understood by the vendors so that they don’t tell us something and confuse us into something else. And so we decided, as we were discussing and looked at various ways others talk about DCT, we decided to create a definition that drives real change. Maybe it’s ambitious and difficult, but it’s a holistic definition of DCT that still has a bit of flexibility because we know this field is evolving and we agreed that our definition of decentralized trial must have, DCTs must have at least four core capabilities, which I will list in a moment, and an additional four optional capabilities that we will explore as we progress, and then one core element to the study design that must be there. So the four core technical technology capabilities are eConsent, eCOA, telemedicine, and a patient engagement app or platform. So these four things must be implemented in a study for us to call this a decentralized trial. If it’s one of those, it’s not a DCT, If it’s two of those, it’s not a DCT. And then we added four additional optional capabilities and, and we were very, very careful to make this definition, communicate this definition across all of our internal company because our internal stakeholders were also getting confused because they’re getting all these emails, they’re hearing about this in all kinds of different contexts and so they hear DCT and they think it’s something else. So we needed to invest a lot of time in communicating. Before additional optional capabilities are direct-to-patient shipping, mHealth, home health, and metrics dashboards, so analytics.

Joseph Kim:
Sure.

Hassan Kadhim:
So these we did not, we were not, we did not force the definition to have to include it in every trial, but we kept this opening so that in the future, as the capabilities evolve, we may kind of make it mandatory. And every study not only needs to have the four core capabilities that I mentioned earlier, but must also have a portion of the study design performed at home. We don’t say which portion, we don’t say how much. We don’t say 20%, 50% or 80% or 100%. But we say, we kept it flexible in that some of the visits must be done from home. With this definition, we think that we are able to drive real cultural change internally and drive sustainable change long term. We also recognize that this definition makes it harder for a company of the size of BMS to implement. So we won’t come out and say we have, 80% of our trials are DCT, because that’s not true. I know that, I mean, I’ve heard it in conferences and in other places. Some companies come out and put out some claims and when you dig deeper, you realize they just did eCOA, for example, and they’re calling this DCT or they’re just doing eConsent in like five different countries or five different studies or, let’s say many different studies, but one country, one site, and they’re calling this DCT. The same is true with the vendors because a lot of the vendors that responded to our sourcing events would give us numbers that we found ridiculous, saying like, we’ve done 300 DCTs in the past five years. And then when you dig deeper, you realize they counted the eCOA studies and the eConsent studies, and the patient apps, all of that is lumped under the umbrella of DCT. So it’s really confusing for us when we’re trying to find a partner because we have to dig deeper into every claim and that makes our sourcing process much longer. So that’s how we defined it, living with the consequences of this … as I mentioned, it’s not easy. It creates a lot of work, but I think it’s good for the long term.

Joseph Kim:
Yeah, yeah, first of all, I knew I could count on you to actually give me a cogent, like, reasonable answer that I fully understand. Tons of questions, though, Like, so why? And I think I know the answer to this question, but I want to hear from you. Why not just define it for definition’s sake? Why were you motivated to define it so that it drives change?

Hassan Kadhim:
Wow, that’s an excellent question. And maybe it’s partly, so you asked me earlier where I spend most of my time, in established or the new up-and-coming. I think the established capabilities are, the good thing about the way my group is designed is that we learn a lot from how these established capabilities evolved over time. I’ll give you just an example. You would probably survey electronic …, and today they will tell you they all have some form of electronic … on file, that’s today in 2022. Five years ago, maybe they did it, maybe they were still doing paper or some form of e-binders. But to get to the point that we are today, someone must have, A, innovated with ETMF and eventually driven change at scale to get to the point where ETMF is second nature today, we do it like, we wouldn’t do any trial without it, same thing for EDC, and I believe that all, every one of the capabilities that we have, and I run a team of 17 capabilities, so 17 large capabilities that enable the conduct of all of our trials, to get to decentralized trial to a point where it’s a capability we need to drive real sustainable change. I’m not, I was not interested in doing a pilot here and a pilot there and then go claim glory that we’ve done it. I’m interested in really changing the way BMS conducts trials so that at the end all the patients, regardless of where they are in the world, experience this change and experience a better access and a better experience to clinical trials. So that’s really why I’m interested a lot in meaningful change rather than experimentation. Specifically for DCT, I think we’re way past the stage of experimentation. For other innovations that are not fully tested, maybe we still have to experiment. We obviously do smaller experiments, much more reserved, probably one country, just one size, and so on and so forth, but for DCT, we’re way past that stage.

Joseph Kim:
Yeah, now, excellent answer, I love it. It just shows your commitment to the space and to the larger vision of why we’re doing it. Because I think a lot of people lose the plot on DCTs, right? On some level, DCTs, or on many levels, DCTs were supposed to allow better access because people could do things and not have to take off 3 hours on a Monday for 12 weeks. I do wonder, though, if we end up requiring people to still go into the site for some things, but then also have to do things on Tuesday and Wednesday, like, have we actually made it easier? So I’d love your thoughts on that versus like getting things done in one fell swoop, yes, You have to take off 3 hours versus still having to go in the site because of the primary endpoint, let’s say, so, yeah, you cut your visit down to an hour, but now you also have to do stuff Tuesday, Wednesday, Thursday, like, how do you think about that?

Hassan Kadhim:
Yeah, that’s an interesting question. I think there’s two ways of looking at that. So when you design a clinical trial protocol, obviously you’ll design this, you’ll put the scientific rationale for it, as a study team, clinical development team, they’ll have a lot of deliberation and debates as to how many, how many visits we need, what kind of endpoints we need to collect, what kind of data we need to collect, and so on and so forth. I think within traditional clinical development, we are still thinking in snapshots of time. So the traditional clinical trial will look at trying to minimize burden on patients by putting maybe 12 visits over an entire year, so one visit per month. And they may, they might ask the patient to do some things at home and kind of bring it to the next visit, right? But they, if it’s important for the study, if a specific activity is important for study, it will be defined in the protocol and it will be considered a protocol activity that is defined as a, in the schedule of events. So if you translate this kind of traditional protocol into a decentralized trial, you might go from 12 visits in person to maybe six visits in person and six visits at home using telemedicine and so on and so forth. That in and of itself I think is an improvement because you’ve cut the travel time by 50%. Now DCT provides now another opportunity which is collecting digital data between visits, which is what you alluded to. If you come on a Monday, you might still have to do some things at home on Tuesday, Wednesday, and Thursday. My understanding of generally traditional trials, we don’t do a lot of you must-do things at home Tuesday, Wednesday, and Thursday, but DCT provides that opportunity. I think it still adds a level of burden to patients if you mandate specific activities. So if you ask them, you’ll need to fill this diary every day, answer a few questions on your phone, it might take 5 minutes, but you must do it every day. So there is that burden that we must consider before kind of definitely adding this kind of assessment, but we don’t have to do it. And when you talk to clinical scientists, they question because they recognize this notion of burden on the patient. If you don’t need to collect something, don’t collect it just for the sake of, because you can, right? Otherwise, if you want to collect continuous data, do it using an mHealth wearable, and that, a lot of that data for, in today, in 2022 is not necessarily used for primary outcomes or even secondary outcomes. A lot of that is exploratory data, we collect it to see if we can use it, but we don’t have the rigor behind that data yet to make it part of everyday clinical trials. So you don’t have to cap what I just had to recap, you don’t have to, you don’t necessarily have to collect in between visits, and every single outcome or assessment that is proposed is questioned. In the same way that we would do it for a traditional trial, we do it for a DCT because you don’t want to add more burden on the patient.

Joseph Kim:
Yeah, I mean, I really like that first example of, if you can, if you have to do things at home, but you can avoid the site visit altogether, that’s probably worth it, for sure. And then to your second point, yeah, let’s always be stingy about what kind of things we’re asking people, dumping on people and not just over request.

Hassan Kadhim:
Exactly, and it’s the same thing. We do that in traditional trials already, this kind of consideration already happens.

Joseph Kim:
How hard? Let’s move to like coordinating all this stuff because in a traditional brick-and-mortar trial, you just kind of know and you don’t have to worry about things in the visit because you just know it’s all happening under one roof and the site will take care of it, whatever it is. When you now have things and you’re coordinating a telemedicine and a home health and disbursement of wearables or a connected scale, how do you, that opens up a whole other problem of orchestration, let’s call it. How do you think about that? How do you help the clinical operations folks connect those dots?

Hassan Kadhim:
Yeah, so, I suppose that every pharma company is organized in a way similar to what I’ll describe, which is there’s a division between clinical development and clinical operations. So you got your clinical development folks that design studies that are subject matter experts in the disease indication the therapeutic area. They are connected with various experts, key opinion leaders. They have, they go to different scientific conferences and so on and so forth. So we bring the science behind why a protocol is designed in a specific way. These are the key decision-makers when you want to do a decentralized trial, you have to talk to these departments first. And depending on how large the pharma company is and what kind of therapeutic areas they’re focused on, it might be different kinds of people that you talk to. So talking to oncologists is different than talking to the …logists, and it’s different than talking to cardiovascular doctors, right? A different culture, different way of thinking, and so on and so forth. So each one of these TAs thinks differently, but they all end up designing a trial. So the orchestration starts there and you need to convince these individuals, these teams, to, from the beginning, think of a trial in a decentralized fashion, because the alternative is you find a trial that’s already been designed and you retrofit it for DCT, and that’s a whole other ballgame, and that’s, that’s.

Joseph Kim:
Yeah, that’s not, that’s failure, right? That’s not scaling. That’s, that’s just like, yeah.

Hassan Kadhim:
That’s what you do when you’re piloting. You try it and you try a smaller scale, but if you’re trying to scale, you can’t do this because that is, you’re creating a barrier from the start. Trial has been designed, now you’re asking everyone to change their design, that’s a huge hill to climb. So you need to start at the beginning when the trial, when you have maybe 12 months between trial-concept to first patient, first visit. At that point, you have a lot of time to discuss and shape the protocol, do all this orchestration look at the number of visits, maybe reduce some visits, see where you can introduce telemedicine, where you can do remote eCOA, whether or not we can do remote eConsent. There’s all kinds of discussions that need to happen at that level.

Joseph Kim:
So, before that, like that is a that’s a really hard thing to do because you need somewhat of an expert in almost every one of those areas to be talking to the oncologist or the medical monitor to just make them think differently. How many times does the door get slammed in your face to say, no, thank you, not on my trial? I’m going to do it the old way. Is it 90-10? Is it 50-50? Better than that?

Hassan Kadhim:
I would say it’s probably 95-05. It’s a very difficult thing to do because, again, you’re climbing a hill already. A lot of, a lot of these groups are accomplished people that have high degree, that are very smart people, they know what they’re doing, they understand the medicine behind a specific disease, they understand how a disease works, they understand the patient population. And then you’re coming with this digital capability and you’re trying to sell it, so very politely, a lot of people tell you this is not a fit from the get-go, but I think this is where, as an organization, you invest in change management, you invest in creating a hype internally. And it’s not just the fake hype, you really create a hype because you have something that you’re, and you have resources, an entire team behind it to deliver on that hype, right?

Joseph Kim:
And then what’s the big promise, though? Is it to enroll faster? Like, what’s, why would you, why would someone get over the hump of the hurdle of saying like, I’ll do it?

Hassan Kadhim:
Yeah, that’s the million-dollar question because we, I’m very careful of not making a promise that I can’t keep. I’m not a politician, otherwise I’d be making a lot of promises. But frankly, the single big promise that, I mean, the single big reason that we are capitalizing and right now is, remember what happened in COVID? Remember when you had a trial designed and suddenly everything shut down and you were scrambling for solutions? And I remember in the heart of COVID, I was receiving calls from clinical teams saying, hey, my trial is stalled. Can you do an eConsent for me? But no, I can’t because I need to find the vendor.

Joseph Kim:
Where were you during the last year?

Hassan Kadhim:
Exactly, and can we collect data using the Apple Watch? Like, can we just send Apple watches to everyone? And obviously, I can’t, we can’t just do that. We don’t even know if it’s validated medically. So we don’t want to face this situation anymore, and a lot of people remember that time and they recognize that we need to be prepared as an organization to provide that kind of flexibility in case something shuts down. But most importantly, I think the pandemic forced the general consumer to digitize everything. We digitize our grocery shopping, we digitized school for kids. The general population, in general, has accepted the fact that there’s another way of doing things. So maybe I can do this trial 50% from home, why not? If it’s, if the company gives me that option, I probably do it. And they are, a lot of clinical teams as they do kind of patient adboards and they talk to a sample representation of the patients of interest of a specific disease, they’re hearing that feedback. They’re hearing feedback from patients saying, well, it would be good if you make the trial less burdensome for me because I don’t want to travel 16 times during this year. I’d rather, if you can do it ten times, actually much better for me. So they’re hearing this feedback, they’re hearing the hype outside from the tech vendors, and there is an incentive for different teams to jump on that bandwagon. So it’s not as difficult as it was maybe three or four or five years ago, but it’s not a walk in the park still.

Joseph Kim:
And then yeah, so, so back to the orchestration question. Once you’ve convinced a medical scientist to agree to do things remotely, now you have the heavy burden of making it happen because there’s a lot of point solutions out there that are probably great, but few that stitch it all together. So how are you solving that in the short term?

Hassan Kadhim:
Yeah, and this is where the power of partnership comes in. And earlier I said we have a very strong partnership with our IT colleagues and our procurement colleagues so that me and my team can focus on the business, can focus on the strategy, and we let other groups focus both on making the right deals for us and making sure the technology is integrated with our current ecosystem. So we get involved, but we don’t own these parts. But I don’t think, I think having to go to five different solutions for a trial becomes a barrier in and of itself. So if a study agrees, if a study team agrees to design their study amenable for a decentralized trial, and then now I got to go and contract with five different vendors, I won’t be able to deliver. So I think the key here is to establish solid partnerships with vendors that can provide more than one solution that’s already integrated.

Joseph Kim:
Or at least work together, right?

Hassan Kadhim:
Exactly, and you have, you don’t need to contract with them for every study. If you have, for example, an enterprise agreement, that reduces your timeline by a lot so we can deliver, we remove that barrier from the contracting and the technology integration barrier, because we do all of that upfront and we focus just on making sure that we can meet the study design and making sure we can configure whichever platform in the right way so that we can meet the DCT expectations.

Joseph Kim:
And then, so one final detailed question, when it then gets to the site level, like all these sites work a little bit differently, what happens if somebody doesn’t want to buy into all of it, or do you exclude them or do you find a way to accommodate that, and does that complicate things also?

Hassan Kadhim:
That definitely complicates things, and that’s not that we haven’t been able to fully crack yet. I think that that’s where as an industry, this is not a BMS-only problem, Pfizer or Sanofi, or Lilly problem, this is something as an industry we need to tackle collectively and I’m sure I know there are already some consortia and groups that are working to bring sites up to speed. I know ICRS is doing a lot of work there and there are others, but there’s definitely a very heterogeneous landscape on the site side. For every one of the DCT capabilities that I mentioned, some sites you will see are very technologically driven and they have already a suite of DCT tools that they bought and they configured for all of their trials. So they would tell us, we don’t want to use yours, we already invested in ours, there’s that type. There are some sites that will relish on any technology you can give them and they will accept anything you give them. These are sites we like to work with, and then there are sites that resist everything. And then you add on top of that the complexity of you must do it differently in different countries because the regulations are not all aligned. So it’s a mishmash of a problem at different levels, and on the regulatory front, we work with our regulatory teams to get insights into what we can do in which country, and we adapt the study design accordingly, but on the site side, I think it’s a, it’s a wild card because one thing we can do is doing the feasibility questionnaire process as we evaluate sites and select sites and so on and so forth, we can add specific questions to evaluate the sites’ readiness to take on a DCT study. And that’s something we’re currently, obviously we’re evaluating and I’m sure many different sponsors are doing the same. Nevertheless, what we are seeing is many sites are just not ready and we can’t just exclude them. At the end of the day, it’s the science that matters. We want to deliver new therapies to patients. So I’m not going to disqualify a site that can bring me 25 patients just because they can’t do DCT, and that way if I were to, if we were to do that, we’d make the medicine less accessible for patients. So it’s a much more nuanced approach that we take. We work with these sites and we recognize that this, in and of itself, is a large change management curve that we need to embark on, and it will take time. But as long as we become the source of change and we align with those sites that are willing to make the change, I think it’ll take time, but there’s a path to success.

Joseph Kim:
Or might there be a future where, gosh, you can, it’s, the system is, you know, the system is flexible enough to do a mix of brick-and-mortar that just want to do things traditionally and sites that do DCT and then like virtual sites that no one ever comes in at all? Maybe that’s, right, there’s probably room at the table for everyone eventually.

Hassan Kadhim:
Absolutely, and I think this is where the future is going because you can’t change all the sites all at once, at various levels of readiness, and there are various factors that influence that. To your point, you just brought another point, which is the virtual site, which is, this is a new player that’s coming into this space. There are many vendors that are launching these virtual sites offerings, which really wasn’t there two years ago, and I don’t think pharma necessarily is fully ready to take on this new concept, this new player of the virtual site. That doesn’t work for every TA, and I don’t think we necessarily know how to work with them across every TA, but it’s definitely a very interesting player that we need to leverage and see how we introduce we include into our DCTs.

Joseph Kim:
Yeah, I mean life is hard enough, right? Listen, as I predicted, this conversation went longer than I had planned. So thank you for spending extra time with me today. One final question, though. Like, let’s fast forward three years. Give me very quickly, what does success look like to you personally?

Hassan Kadhim:
In three years, I would hope that we have enough experience with DCTs, both at my company and in the industry, that we’re no longer struggling with the definition across different partners and different industry players, and that it is a viable option that is always considered for every study design. That’s what success looks like. If I’m, if I close my eyes and look at July 2025, that’s where I would hope we are.

Joseph Kim:
I love that response because it’s truthful and it’s attainable and it’s probably the most realistic. You’re not getting over your skis at all. You hear other folks say like, 50% of trials will be remote, like get out of here. Anyway, thanks so much for spending time with us today. This, actually, believe it or not, this is probably the longest time you and I have ever had kind of a one-on-one conversation, all times we get drowned out by other voices, but it was really a pleasure to talk to you at length today.

Hassan Kadhim:
It takes a podcast to get us to talk that long.

Joseph Kim:
That’s right, but thanks for coming, and have a great day.

Hassan Kadhim:
Thank you.

Joseph Kim:
Thank you for tuning into Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPoint.com. If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to help@ProofPilot.com. This show was presented by ProofPilot and is powered by Outcomes Rocket.

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Things You’ll Learn:

  • The four core technical technology capabilities a Decentralized Clinical Trial must have at BMS are eConsent, eCOA (Electronic Clinical Outcome Assessments), telemedicine, and a patient engagement app or platform.
  • The four additional, up-and-coming, optional capabilities a Decentralized Clinical Trial should have are direct-to-patient shipping, mHealth use, home health application, and analytics.
  • A lot of the collected data in clinical trials are exploratory to see if it can be used, but without the rigor behind it.
  • If you want to do a DCT, you need to start planning a year ahead of the first patient enrolled and it must fulfill a specific need. 
  • Retrofitting a trial into a DCT will be more complex than building it from scratch.
  • You can’t apply DCTs across the board. Sites and patients are at various levels of readiness and fit to implement DCTs. In the end, flexibility and customization will be the key both for sites and patients, who may not want to do things remotely or have capabilities of their own.

Resources:

  • Connect with and follow Hassan Kadhim on LinkedIn.
  • Follow Bristol Myers Squibb on LinkedIn.
  • Explore the Bristol Myers Squibb Website.
  • For more information about Research Confidential please visit ProofPilot.com.
  • If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com.
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