TRANSCRIPT
Welcome And Why This Matters
Deena Bernstein
Hello and welcome to the Scope of Things podcast. I'm Deena Bernstein with Transformative Pharmaceutical Solutions, also known as TPS, stepping in this month as the guest host for this ongoing insider's look into the clinical research industry, game-changing, operational trends, out-of-the-box approaches, and interviews with visionaries and stakeholders in this space. Today I'm delighted to have been invited to lead today's conversation with Ken Getz, Executive Director of Tufts Center for the Study of Drug Development, and Rick Ward, Chief Commercial Officer for eSource Solution Provider CRIO, about clinical trial startup delays tied to protocol guided source preparation process. I've known Ken for probably as long as I've been in this industry and think of him as one of the most iconic visionaries of the industry.
Ken Getz
Oh, thank you so much, Deena.
Deena Bernstein
I'm showing my age too here because I've been in the space a long time, as you have. And I've also known Rick and have seen him evolve as a leader in the solution space and a great industry supporter. And I'd like to welcome both of you to the show today.
Rick Ward
Thank you so much. Appreciate it very much, Deena. And yeah, you and I have known each other for quite some time. And interestingly, Ken was one of the first people that I met in my early days in this industry 30 years ago, although I apologize that's starting to date both of us, but it's great to be part of this conversation with both of you.
Deena Bernstein
It's amazing that that we're still both the that the three of us are all still here standing, right?
Ken Getz
Oh my gosh. Oh my goodness. And let me just add, what a pleasure to be here with Rick as well. We're looking forward to our our talk today.
Deena Bernstein
Great. Well, let's let's jump in then.
The Tufts And CRIO Study
Deena Bernstein
So, Tuf Center for the Study of Drug Development and CRIO, both of you have led this and collaborated and published a study on protocol guided source preparation process. So, do you want to just give our listeners a little bit of info about that? Tell us what your work together was like, and then we can jump into some direct questions.
Ken Getz
So, Rick, I'm happy to kick things off and just say, first off, we were so delighted that CRIO raised this important issue with us. We've been looking at and studying the study startup process for a long time, but had really not looked specifically at this area. What's really involved in the data collection tools and materials that the site prepares once they're given the source document materials from the sponsor. So this was really a new area, and as we'll talk about in a moment, some really, really valuable and important insights that came from this study as well. It was a survey that we conducted among investigative sites.
Rick Ward
And our our interest in this topic really stemmed from a lot of anecdotal feedback we were receiving from sites, especially as we were expanding globally and dealing with different types of investigative sites. And we early on realized if we could reach out and partner with an organization like Tufts that has a great deal of credibility in the industry, and we also knew had a very strong scientific methodology that would not only would it allow us to potentially validate some of the things that we had been hearing anecdotally, but likely help us discover new things about how sites operate, which of course it did. And I'm sure we'll get into some of that. But that was that was a big justification of why we reached out to Tufts early on to sort of power this investigation and this this analysis.
Deena Bernstein
Yeah. So anything site related really hits home for me because that's where I got my start in this industry, building site networks from the ground up. And I say always that the site blood runs through my vein, no matter what role I'm in or what I'm doing. I always think of, well, what about the sites? How would they react to this? And I come from a day when paper source was the only source. And we've evolved since then, which is wonderful. But I think one of the most overlooked contributors to study delay startup and site readiness is source preparation. Whether it's paper or what we're hearing also now is maybe even the e-source. So, Ken and Rick, one of the things that really caught my attention in the in your Tufts collaboration was how something as you know routine as source prep can quietly become this major bottleneck. Was there a moment during your work together where you both were like, wow, this is a bigger issue than we realized? Can you tell us about that?
Ken Getz
So, Rick, I'll be curious to hear your thoughts. I'll sort of kick things off by saying, and Deena, you're gonna laugh. It's rare that something wows me anymore, in part because I just always am amazed at how many inefficiencies we uncover, how many delays and and challenges we uncover. So, at the outset in this study, we hypothesized that this was gonna be an important area and a very revealing factor that was contributing as many other factors are to the steadily increasing amount of time and the high inefficiency during study startup. But what was really unclear to us was more the magnitude of the contribution. So it wasn't really a eureka wow, as it was an affirming wow in my case. Rick, what are your thoughts?
Rick Ward
Yeah, I think our our our wow moment overlapped quite a bit from the perspective that going into this analysis, I sort of expected that what we would validate is this concern of redundancy, of duplicate effort, right? So you've got a trial with, say, 100 sites, you have a single well-defined protocol. So the thought was source preparation, maybe it's a moderate lift. Does it make sense for every one of these 100 sites to be redundantly going through the same workflow or chasing that same goal of building really good quality source? And so the thought was even if it was only a moderate lift, we we have to talk about the redundancy of sites doing it, you know, over and over and over again across all the sites. But for me, the eye-opener was it's not a light lift. It's in many cases, it's a much heavier lift than I imagined. And some of the other research that Tufts has done is connected to the increasing complexity of protocols. And so when you think of the increasing complexity of protocols, that means that this heavy lift, this burdensome lift of building source is potentially only getting more burdensome because to build source for a more complex protocol is a more complex job.
Deena Bernstein
Yeah, that was, yeah. So that was your wow.
Rick Ward
Yeah, yeah. It was both of us, I think it was the the the depth of time and resources required in order to build quality source.
Deena Bernstein
Sure.
Why Source Prep Stayed Invisible
Deena Bernstein
When we talk about study startup delays, the conversation usually goes straight to contracts, budgets, or regulatory hurdles. But your work pointed out something different that's much less visible. Why do you think that source preparation has flown under the radar for so long? Well, I agree with you with the complexity aspect of it has changed with, you know, the way that protocols look today. They look different than they did in the past. But why do you think it's it's under the radar that this takes so long for a site to actually, you know, produce?
Ken Getz
Well, one of the things, Deena, that you said a moment ago, you you referred to source prep with such familiarity. Right? It's almost like this has been for a long time. This is even before what Rick described as sort of a catalyst that has made this even more pronounced. You would sort of describe this as a bit of an acceptable hassle, right? It's something we know it, it's it's it doesn't work perfectly, but we've just accepted the challenge. And for a long time, there were other areas, I would say many were almost shared activities, right? Where we weren't pointing fingers, but we knew that the contracting and budgeting process, we knew that indemnification and and IP, you know, all of those areas were initial places where we looked. IRB involvement or ethical review. These were places where there were interactions, there were exchanges, there were there were some inefficiencies and bureaucracies. We also historically would see that often sites were reluctant to single out sponsor specific behavior, you know, because that's sort of biting off the hand that feeds you. So sites were more willing to accept this hassle. And I think there's been more confidence and also more of a recognition to what Rick was saying, that this is becoming a much more burdensome activity. So I think that's a big part of why it slipped under the radar for so long.
Deena Bernstein
Yeah. Rick, any thoughts there?
Rick Ward
Yeah, I think everything Ken just pointed to is spot on. And the only thing I would add is that I think for a long time, sponsors have maybe viewed this as something that happens behind the curtain and it belongs behind the curtain, right? So, like if we're gonna talk about budgets and contracts, those are those are topics that both parties understood that they ought to be, you know, confronting and dealing with together. But there was this sense that source prep is something that should be done behind the curtain at the site side of things. But I think what has happened over time, as sponsors have partnered more closely with sites and we've sort of pulled that curtain away a little bit, when we think about data quality, right? And data science as a field has really evolved in the world of pharma. And as we think about data quality and quality by design, you start to trace back and realize that in order to really deploy a quality by design approach, it starts with how is the data collected and the basic concept that sponsors are realizing if we are going to create and design a protocol and put great resources and thought into how to develop and design that protocol in the most effective way, it seems like a bit of lunacy to then say we're gonna pay no attention to how the data gets collected. And no surprise, you have protocol compliance issues, you have got data quality issues. So I think that the parties are coming together and realizing not only can we address some of these data quality issues, but we can we we can have a significant impact on something like site startup by helping sites have the materials they need to get started enrolling patients faster.
Deena Bernstein
Well, that sounds promising for the sites. I like where you're going with us.
What Happens Behind The Curtain
Deena Bernstein
For those who may not have lived in the weeds of studies startup every day, can you paint that that picture of what is actually happening behind the scenes that keeps the sites from being truly ready? I have my own thoughts, but I'd love to hear yours.
Rick Ward
Well, Ken, I'll start off and then I'm sure you can get into the granular details of the analysis. But this was again part of my eye-opening experience was I assumed that source build was you receive a protocol, you interpret the protocol, you write up your source documents, you're ready to go. And now we're realizing that there are many other documents that are necessary for the site to build good source. Those documents don't always match up with each other. There's a lot of back and forth with sponsors to clarify these things. And if you think about this entire process, this process has to be complete before the first patient can walk in the door. So when we think about the impact on site startup and you start to peel the onion away on everything that happens with how to develop source, it's no surprise. And we're we're because this concept is relatively new at CREO and supporting centrally source, we're just starting to gather data from sites around the impact of supporting source build on enrollment.
Ken Getz
I think Rick really hit on the high points, and I'll just add a little more color. Deena, you I know you have a rich perspective here that just conveys the complexity of this, as Rick said, sort of the behind-the-curtain activity. You know, once the site has been selected and it's been engaged, so the contracts have been signed, the protocol has been ethically approved, the site then waits five to seven weeks to receive source documents from the sponsor. And this includes everything like the final protocol, the investigator brochure, informed consent and case report form templates, case report form completion guidelines. And from all of this material, the site then has to go through what you were describing, Rick. They have to review all of this documentation. They often identify inconsistencies, areas where there may be conflicts between what is said in one document and how it's presented in another. There are areas that require clarification, and then the site has to ultimately prepare and finalize and QC the data collection documents, even before the study is technically initiated and enrollment can begin. So there's this, it's a bit of a black hole with that is ripe for a tremendous amount of time and effort in order to cue things up so that the site is ready to begin.
Deena Bernstein
Yeah. I think sites have really grown up since I started. They've become more professional and more sophisticated based on the experiences that they've had. And when I when I first started, I remember hearing sites ask sponsors for the source document. And the sponsors at that point in time were not willing to provide it. But if you had a good working relationship with sponsors, they might, or through a CRA, they might introduce you to another site that they knew of that had already created the source. And then, you know, you might get a little bit, I'd call it a cheat sheet, of of how to get started and get ahead of it. But everything that you both said, it's a tremendous time that it takes to create a source document for one study and always checking it. One little mistake will throw you off and you know, really put you behind and have major quality issues. And if you don't have a QC process in place, if it's not part of your workflow, and then putting in the time to really do it right and understand what you're doing and getting it right, it's does take a lot of time. But I have seen progress and I'm really excited about that. But it's definitely is something that puts a site in the weeds and having it timed out perfectly and getting all those documents when you need it is really key. And that's something that a a site really isn't, they they have no control over. So when the final protocol is delivered, sometimes it's not till very late in the game. So it even puts you even further behind. Every everything else might be ready to go, but you don't have the right tools to do the job of getting that the source done. So that would even put you even further behind. Anyway, I'm just spewing, but not at all. Some real anecdotal experiences, lived experiences out there for you.
Rick Ward
Well, your your anecdotal experiences make sense. I mean, I and it's mirrored what we've heard as an evolving discussion with sponsors and sites. And the I would characterize this notion that sponsors can't provide source to sites basically as an urban myth. And if that raises the eyebrows of some folks, I would challenge any of our listeners to reach out and let's have a discussion about it because it really has been sort of proven. And if you really think about just using common sense, if you were to provide a bunch of different carpenters with a piece of furniture and say we want you to build this, and we also want you to come up with your own instructions. Well, that's a that's a pretty tough task, as opposed to saying we want the furniture to look just like this, and here is a step-by-step guide on how to do it. Suddenly everyone's going to be following a consistent process and it's it's less work for people figuring out the instructions and it's more consistent in terms of the end product. And that may be oversimplifying the model, but as we've talked to sponsors and work with sites and major site networks, we're finding that this idea of collaborating with the sponsor on source build is not only something that is perfectly allowable and not blocked by any type of regulatory guidances, but is um has tremendous value to both the sponsor and the sites.
Deena Bernstein
Yeah, I agree 100%. That's good to hear. That's enlightening. Sure.
Ownership Gaps And New Questions
Deena Bernstein
So is this one of those challenges where everyone assumes someone else owns it or doesn't think of it at all? Where do you think that biggest disconnect is?
Ken Getz
So, Rick, I'll take this just quickly and then your thoughts are are welcome. But it that's interesting to use the words who owns this process. It's in from our perspective, and obviously we have a little distance at the top center. This to us always felt like a process where the parties understood their responsibilities, but both parties just assumed that it happened. You know, each party had a role to play. The sponsor knows that they need to provide the source documents and that it's really left to the sites to use their own, their own approaches, their own their own experience to ultimately develop the the data collection materials. And that assumption is increasingly more and more misguided, right? Any we're finding in all of our research, any activity that is assumed to simply happen is ripe for scrutiny. And that's basically the bottom line is we just can't make those kinds of assumptions anymore. Our our activities are so complex and they involve so many different parties and so many different solutions that we may be using and approaches that we're using. And so it we just can't make that assumption any longer.
Rick Ward
Yeah, that's that's spot on. And and the only thing I'll say is, you know, when it comes to the research that was done and and and identifying the many, many different types of sites and different types of workflows that exist in in the United States as well as around the globe, it's it's almost an infinite number of models, right? So that makes it challenging. And, you know, Ken and his team have all probably forgotten more about how to conduct research than I've ever known. So I'm far from being an expert. But what I will say is that the one indicator of really good, important research is that when people read it and digest it, they come away feeling like we need to do more research here. And that's one of the most common sentiments I've heard from folks that are reading about this analysis is wow, this is this is opening up some interesting topics. We need to drill deeper. So I think we're really scratching the surface of an area that is is crying out for more analysis, broader global, deeper analysis, and we'll see what we'll see where this leads us.
Ken Getz
Yeah, I Deena, I have to interrupt and just say, Rick, you this is like my mantra with my team. I often say that the mark of a really good study is not as much the answers it provides as the questions it raises. For sure. And we're finding exactly the same thing that this particular study, so many people have commented that it has really opened their eyes to an area of that really requires much more inquiry.
Deena Bernstein
Well, that's really exciting news. I love to hear that. I feel like there's more collaboration and more of a collaborative approach to this whole thing between all the stakeholders involved, whether it's the sponsors, groups like CREO, the sites, all coming together to maybe move the needle to find out well, what if we could do this together and make it easier for all?
Rick Ward
And we're we at CRIO are we're enthusiastic about supporting more research because I think there's a lot of discussion around the partnerships that we've been building with major pharma sponsors. But the the genesis of our company for over a decade has been with sites, and we continue to be laser focused on sites and what sites need to perform their work more efficiently and more effectively. And so that's not changed. We're not, it's not going to change. It'll evolve. We're expanding globally and we're learning more and more about how research is conducted in different environments, but anything that can help clear the air and and and and brush away the confusion between all the stakeholders and really kind of come out with a distinct benefit to sites is is something that we're really dedicated to. So we look forward to exploring this further.
Deena Bernstein
Great. So the next question kind of feeds into what we were just talking about, but source prep isn't exactly the most flashy topic out there. We don't hear people talking about it all the time in the rooms that we go to and the conferences that we attend. But it does have that direct impact on when patients can enroll in a study. So with that in mind, Why do you think the industry hasn't paid more attention to that connection in the past?
Ken Getz
Some of this ties to what we were talking about earlier, that we've sort of accepted this specific part of the process for so long. It just didn't jump to the top of the radar in part because it was get it was getting done. And although there was a lot of pain involved, I think a lot of sites just sort of kept that pain to themselves.
Deena Bernstein
Yeah.
Ken Getz
And I agree with you. It's not particularly flashy. I'm so excited, Deena. You when you use the word source prep, you say that with so much energy. So because you know, you know exactly that, right? This is a this is an important area. I think what Rick said also is really important. It it's a downstream activity, right? We've been so focused on upfront getting the site started that we don't look at those interim steps a little bit further downstream. And I think that's probably the great value of the study. It really pushes our thinking, moves us downstream, where we see that this is such a critical gateway with inherent inefficiency and problems that, and this introduces all new opportunities for us to drive efficiency and performance.
Deena Bernstein
Yeah. Rick, do you have anything to add to that?
Rick Ward
I think Ken covered it really well. Yeah, no, I think you feel free to share your next question with us.
Deena Bernstein
Sure.
Redefining Site And Sponsor Readiness
Deena Bernstein
So after doing this work together, has your own thinking changed about what site readiness really means?
Rick Ward
It has for me, just because as we talked about earlier, the the depth of work that is done at the site level, I think historically, I probably, like others in the industry, assumed that once a site had final protocol, they were green light, ready to go. And and understanding the history of how sites have traditionally had to build source on paper and the really strong transition from paper systems to e-source type systems, I think is for me, has certainly shed light on the fact that there's a whole lot of things that have to happen other than just having a FIDO protocol before a site's really ready to enroll.
Ken Getz
Yeah. And I would say, I would agree completely. And I would say that we learned a lot in this study. It really opened our eyes and really changed our view. We we now see site readiness as so much more expansive that, and it's really collect, it's really reflecting a, I would almost say, a continuum of opportunities that can be optimized, where we know that performance can be improved. I guess to put it even more clearly, readiness has such a dynamic meaning and it it covers so many multiple, so many different sort of preparatory steps. There's the readiness to begin setting up to receive the study materials and final protocol. There's the readiness to begin building the necessary infrastructure to run the study, to collect the data. Then there's the readiness to begin screening and enrolling participants. And these all sound so obvious, right? But they really haven't been, right? There have been areas in that process where we just weren't, we were not as alerted and as aware that this was an important part of that overall startup process.
Deena Bernstein
Yeah, it would be really interesting to think. I'm just thinking out loud. So you've done this work, this study on specifically the source, the source builds and how the sites, how it impacts the sites and their readiness. But imagine if you broke down every little piece of that site readiness and then did a you know a lot of studies and then put them all together. It would be that would really be amazing to see.
Ken Getz
I love that.
Deena Bernstein
Very eye-opening.
Ken Getz
It would be. And I would also add, so I'll raise a few eyebrows as well, is we often think of site readiness as the sort of the explanatory term for a study being ready to go, but there's a sponsor readiness component too that has really shed that been been sort of illuminated in this study, right? As you said, Rick, final protocol does not mean the study is ready to go. And I would even underline the word final. We often don't see a final protocol. So there's there is a lot of sponsor readiness that has to happen too.
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The 21 Plus Hour Burden
Deena Bernstein
Now let's move on a little bit and to the part that I found astounding, maybe not so surprising because I lived in this world, but some of the studies said that in specific findings, starting with that heavy burden of the source preparation for the sites, that in most cases it took 21 hours plus for those high complexity studies to be built into a source. So, Ken, did you find that metric surprising? And how does that workload today compare to earlier years?
Ken Getz
Yeah. I guess again, I'm not surprised easily anymore. But you know, 35 years looking at this data, sort of macro level, I'm not really surprised, but I do recognize that 21 plus hours per study is a lot. And , you know, we've sort of alluded to this already. We know that this is getting worse, it's getting longer. We have just seen the steady increases in workload and capacity. We've seen timelines get longer and longer, the costs, direct costs as were as well as variable costs. We've just been seeing this constantly in every area that we cover in our research. And as I mentioned, these increases have been steady for decades. You know, part of what this gets at is something that I know you've you have thought a lot about as well, Deena, Rick. I know you you live this, but it's that constant and extensive impact that comes from these primary sort of underlying causes. And they're really they fall under the umbrella of complexity, but they really are characterized by just this high level and increasing level of customization, you know, both scientific and operational customization in our studies and the growing fragmentation, all of the different intermediaries and technologies that we're introducing, we just face a period of hyper complexity. Every trial is different, and each one of them, you know, requires different workflows and requires sort of a unique approach to managing and executing.
Deena Bernstein
That 21 hours in the past, it probably didn't take 21 hours when I first started in this business, but it did take a long time. But now I think one of the good things in favor of the sites is there are sponsors out there that would recognize that this is, you know, time, hours of labor that you know are uncompensated. And one of those hidden costs, I always work with SERS on a workshop called the hidden costs of budgeting and clinical research. And lo and behold, every time somebody brings up, you know, those those hidden costs and study startup. But 21 hours, I think now sponsors are starting to understand that there has to be some sort of compensation back to the sites for that time that they take to create these documents to get started.
Ken Getz
Yeah, and that's a really good point. I mean, the we always try to gather these types of metrics. For sponsors, it may not feel like 21 plus hours is that long, right? I think for some it will, but for sites, it gives you really a baseline measure now. And I think I think you're right, Deena. I think some sites will point to that a year or two from now when it's now 25 plus hours, and they'll say, This, if we don't address this, this is a massive burden that we're managing.
Deena Bernstein
Yeah. And all sites, you know, are different. There's no two sites that are the same. And sometimes it's the same person that's creating the source that is seeing the patients. And I think we'd all really be disappointed to know that somebody's behind the scenes creating a document that's used for a study instead of seeing a patient or you know, enrolling a patient into a study.
Rick Ward
Yep.
Deena Bernstein
Rick, do you have anything to add there?
Rick Ward
No, no, I think you think you covered that really well. It's it does tie into industry perceptions around who ought to be involved to what degree in terms of the various tasks and the fact that sponsors are in a position to help really alleviate a tremendous burden on sites and at the same time improve both enrollment timelines and data quality is a strong enough sort of multi-armed argument that it's worth us, you know, really spending more time on this.
Paper Systems And EHR To EDC Reality
Deena Bernstein
Okay, now I have a techie question for you. And Rick, I will pose this to you. What about the technology gaps in terms of how source data is being captured? I think that some listeners may be surprised to learn that in 2026, paper-based systems are still predominantly in place where sites are capturing the study information. So, what does this mean for EHR to EDC integration, which is another hot topic in itself, which we've been talking about seemingly forever, and needed changes to speed up the adoption rates of the electronic systems?
Rick Ward
Sure. So you touched upon a couple of really important things there. I mean, one is there is a very clear and powerful trend in the direction of sites adopting electronic systems. Yes, there still are a lot of sites out there using paper either as their primary tool for collecting data, or in some cases it's more of a hybrid between electronic systems and paper. And the the Tufts research showed just how complex the the world is in terms of the different mixes of paper and technology that are being used. But the trend is very much in in the direction of technology and not just with your major hospitals and your major site networks, but standalone, as you mentioned earlier, Deena, standalone research sites are becoming much more sophisticated. I think the old expectation or the old explanation rather was that you know maybe sites were sticking to paper because it was more convenient to not have that detailed audit trail. I think that's a bit outdated. I think sites are past the point. I mean, sure, there's still are there's still that's still out there as a concern.
Rick Ward
And every now and then you hear about fraudulent activity and clinical research, but by and large, I don't think that's the driver of sticking with paper systems. I think it's just a matter of choosing the right technologies and the time it takes to do that. And I think in certain regions of the world where paper source is still predominant, they just maybe haven't advanced as rapidly. But there are areas of the world that actually have advanced more rapidly in adopting technology in areas outside of clinical research. So it's in some cases, it's our industry holding it back, but we're seeing a tremendous trend in the direction of adopting the technology. We're seeing sponsors and CROs placing a higher value as we move towards wanting to digitally enable sites. We're moving towards things like digital protocols and interoperability of systems. So as sponsors and CROs are placing a higher value on this, and sites want the ability to support more studies, deploying technology is certainly a very powerful trend. But there are there are obstacles to overcome.
Rick Ward
And the other point you mentioned that which I have to expound upon is this concept of EHR to EDC interoperability. One of the things that has been eye-opening to me over the last couple of years since I've been with CREO, and I continue to see eye-opening reactions within industry, understanding the difference between EHR to EDC integration, which really focuses on, say, oncology and other in-hospital type studies, because that's where EHR systems are used, hospitals and major academic institutions. But for the many, many research sites, large site networks, other research-dedicated organizations that are not providing standard of care the way a hospital would, they do not have EHR systems. Right. And there's been a realization in the market that what these sites are relying on is historically paper source, but increasingly the use of tools like eSource. And that's providing a great opportunity to overcome some of the challenges that EHR to EDC integration that have created. And we have great opportunity to leverage protocol-driven source to facilitate EDC integrations and help to address the ongoing issues that sites have had with manually transcribing data into systems.
Deena Bernstein
Interesting. Yeah, that a great point, especially about the large networks, you know, and anybody that's out, any type of site that's outside of a clinical practice that wouldn't have access to EHR. So I think it goes even just beyond those, right?
Ken Getz
I'll just add, Deena, just to what Rick said that from where we sit it. And I certainly agree with everything Rick you mentioned about even some of the structural differences, right? We do see even in this study, the adoption of eSource was so highly variable with academic institutions and standalone community-based sites indicating much, much lower levels of adoption than we were seeing in the larger site networks. I mean, what a lot of this speaks to is that we have so far to go to realize the conceptual promise of EHR to EDC integration. And it's not just about technology and interoperability, it's not about, you know, data heterogeneity, data diversity. It's really about the underlying lack of sophistication that we see. And that's a that's just a fundamental area that helps explain why adoption has been so slow.
Deena Bernstein
Yeah. Okay.
Fixable Bottlenecks And Early Site Input
Deena Bernstein
The next question is for you, Ken. And I'm gonna ask that during your site interviews, they revealed a long list of inefficiency is associated with this source preparation process. But let's talk a bit more about the bottlenecks in terms of what sponsors and CROs or even sites themselves could proactively do after talking with so many of these stakeholders. Like what stood out as something that would be the most figure -outable bottleneck and where that low-hanging fruit potentially could be, where small changes could have some sort of meaningful impact on the site's readiness.
Ken Getz
So I'll share what we heard in the interviews, but I'm gonna put this right back to you, Deena. This is sort of your on the salt box as someone who has this direct experience, and and Rick, I'll obviously invite you as well. I always get nervous when we call things low-hanging fruit because nothing is nothing's ever as easy as we think, right?
Deena Bernstein
Never.
Ken Getz
But there were some areas that were thematically noted quite a lot. They all add some additional time, but it's all upfront time that will make that will contribute to really important downstream improvements. And so a lot of the themes addressed really ways that we could address the bottleneck by getting the site involved much earlier in the process, providing feedback, right? Getting a quick read on some of the draft materials, and even having like a data warm-up exercise with mock data before you really go live, right? So there were important places where that this kind of warm-up or upfront activity would streamline some of the preparation and finalization. One of the areas that the sites pointed to time and time again, though, is the idea goes back to the instructions that the protocol that's provided and how often that protocol is kind of a moving target, right? And there's no such thing really as a final, or it's rare to receive a final protocol that that won't undergo additional revision. And I so I think that there were lots of interest in encouraging the sponsor to spend more time up front to review and identify inconsistencies prior to having the site have to do so, and also to really drive toward as final a protocol as possible before sending it out to the site and having the site initiate the source prep process.
Deena Bernstein
Yeah. Okay, so I'm up for the task, but it's funny that you said, which always seems to be the answer of every initiative I've ever worked on in this industry, whether it would be with DCTs, with DTRA or SCRS initiatives, the sites always say, or the patients always say, why didn't you get this to us earlier? Why didn't you let us review the protocol earlier? Like for, for instance, you know, with with patients, or why did you decide for us, what kind of technology you thought was going to be best for us to use? And in this case, it's really about getting the site the tools that they need in a timely manner. And a lot of times that isn't always possible. I've been on every side of this and understand why the delays happen. It doesn't make them right. But if the sites did have plenty of time and they weren't, you know, under the gun to get the job done, then I think we could remove that bottleneck. So you hit it, but it's always the same answer.
Ken Getz
I'm sorry. And then, of course, as part of that answer is the notion that almost everything requires some investment of time. And, you know, to a large extent, often what it's hardest to put that time up front. We are so eager to get the study out to the the clinic, right?
Deena Bernstein
Yeah.
Ken Getz
But if we put that time in up front, it it could make such a huge difference. That's really tough.
Deena Bernstein
Yeah. And you just it was really enlightening that that you did say to do, you know, the simulations. And a lot of sites I know do, you know, walkthroughs, but I don't know that they've ever really looked at their forms before. I'm sure there are sites out there that do that, but they'll, you know, go through the process like of the study and do a whole simulation, sometimes even with a patient. But that taking that step and really reviewing the forms in your CTMS and in your e-source and the informed consent and ensuring that all those things are, you know, correct as well is time well spent. I'll just say that.
Ken Getz
And maybe, maybe there is a role that an AI-enabled process can help with as well, right? Finding some of those inconsistencies. Rick to the point you made about digitized protocol, or there may be some really very, very manual, time-intensive tasks where an AI-enabled approach could be helpful. So, I mean, that I think it just points to places where there may be some really important new opportunities to streamline and and improve on this process.
What Changes First And Why
Deena Bernstein
So, Rick, if the industry does nothing to make any changes, what do you think we're we're leaving on the table? Where whether it's time, money, enrollment, or site experience, what is really at stake here?
Rick Ward
Great question. I love starting the question off with if the industry does nothing. And and listen, I'm probably as critical as as many others are around our industry's inability to move in a more nimble fashion, but I also understand and respect the reasons for that. And I would be the first to say that although we may sometimes move slowly, rarely do I see us as an industry make a decision to do nothing. I think what will happen is there will be sponsors and site networks and individual sites and CROs that really heed the learnings here and decide that they're going to, you know, take be the tip of the spear for change. And those are the organizations that, as pioneers of any new evolution in our space, reap the greatest benefits. And others will follow. There, there will be new standards set. And that's why we feel like the industry moves very slow because it's a long time before everyone gets on board. But for every innovation that exists out there, you can trace it back and see you know who were who were the ones that really kind of were at the forefront.
Rick Ward
In the time I've been at CRIO for the last couple of years, I've got a pretty good sense of not just organizationally, but even individual thought leaders in the space that are really pushing the agenda of addressing these issues. And I just think that what's going to happen is that they will they will be the ones to take the chances, they will be the ones to make the investments. And then as the return is measurable and quantifiable, you will then start to see a more widespread following. So to answer to answer just the first part of your question, I absolutely have the faith that we will react to this research, do more research and implement changes. And I'm already seeing it. We can take this offline with anyone that wants to learn more. But there are sponsors and CROs that have really invested in how to meet sites in the middle and support them more in this arena. And they're already experiencing positive results, both in terms of enrollment timelines, in terms of relationships with sites and site engagement, and in terms of data quality.
Deena Bernstein
Wonderful. So exciting to hear that. So, Rick, I have one final question for you to wrap things up. Career offers an eSource solution for collecting data directly at the point of patient interaction to lighten that site burden and increase enrollment and startup speed. Yet, great as that is, not every clinical trial site or sponsor or company has embraced this or any other eSource for that matter. So, what do you hear in the field that is the limiting uptake, including like, you know, what has been reported in this latest study that you've done?
Rick Ward
Great question. And hopefully this isn't the question that causes half the listeners to log off because they think they're about to hear a sales pitch. Nope. Um what we have seen in the market is first of all, a very high degree of interest in this study. I've been at some major conferences with Ken. We've invited pharma leaders and CRO leaders and site leaders to come to dedicated focused discussions, and folks are showing up and they're showing up engaged and they're showing up with lots of questions. And that in and of itself is a really good sign. Signal. Yep. Yeah, it's a very good signal. I really think that in terms of I wouldn't say what's missing. I would say, you know, this is what is helping to move the ball forward is active dialogue, people willing to let go of preconceived notions around who should be developing source and whether, you know, the reasons for using paper and all of these things and having open dialogue and really understanding what is the status quo, what are the what is the cost of the status quo, and what is a future state, and what is the potential cost for that future state, and and be willing to pilot and test and explore. And I don't think that that's missing. I think we're just at the early stages of it. We're really only two years into the very earliest pilots of the central eSource concept. But the group of sponsors and CROs that are highly engaged in looking and wanting to pilot and explore the central e-source concept is growing tremendously. Obviously, we're we're developing more robust interoperability and integrations with the major EVC companies, and that's a big big part of this process. But I think we're I think we're on a on a good track, and and I'm eager to see more research conducted by Tufts to pull this, pull the curtain away even more.
Deena Bernstein
Wonderful.
Wrap Up And Scope Europe Offer
Deena Bernstein
Well, I think that's a great place to end and a promising future for us. So let's end it on that positive note right there. So, Ken and Rick, thank you both. Conversations like this remind us that improving clinical research isn't always about the next big thing in technology or that next big shiny object, but it's about bringing the right people together to rethink the way that we've always worked. And today's discussion sparked any new ideas or challenges or challenged us along a long-held assumption that we've done exactly what we hope to do today. So I would also like to thank everyone for listening, as well as personally inviting you to subscribe to this podcast if you have not done so yet. And please help spread the word among your friends, online communities, and social media posts, and the meaningful dialogues that the scope of things, and just please join us again. And one more thing before we go, if you like today's conversation, I'd like to remind you that it's only a glimpse of what you can expect from presenters and panelists at the upcoming Scope Europe event in Barcelona on October 13th and 14th, where clinical operations executives will be exploring the latest trends in clinical trial innovation planning and operations. And I'm told you can save an additional 10% off of any current rate by using the code SOT10. More information will be available by visiting scopesummiteurope.com. Bye for now.