Breaking Down Site Complexities and Start-Up Barriers in Clinical Trials

Jessica Thurmond: 

Glad you could join us today. Hi everyone, I’m Jessica Thurman, Program Director at WCG, and I’m thrilled to be your host for today’s episode on breaking down site complexities and study startup barriers in clinical trials. Before we dive in, let me remind you to subscribe to our podcast and follow us on your favorite listening platforms like Apple Podcasts, YouTube, and Spotify, so you never miss an episode of WCG Talks Trials. We are joined today by Pat Harrington, Senior Vice President Clinical Solutions at WCG, and Brad Gruner, Vice President Site Services WCG. Thank you so much for joining us today. Before we get started, can you tell us a little bit about your background and current roles? And we’ll start with you first, Pat. 

Pat Harrington: 

Hi, thank you, Jessica. Yes, as you said, my name is Pat Harrington, and my clinical background is in the area of psychology. I’m a clinical psychologist by training, and so I’ve done a fair amount of work inpatient and outpatient, and worked with the federal government, state of California, where I currently reside, and then got into the industry with INC Research, Syneos Health, worked on the CRO side, and then also spent time on the site side before coming to WCG. So I’ve had a, I think, a, an interesting kind of bit of history and seen clinical trials from kind of a pretty broad view. 

Jessica Thurmond: 

And Brad 

Brad Gruner: 

Yeah, thanks. As just mentioned, I am Brad Gruner, vice president of our site services team, overseeing the work we do for study startup work, supporting sites across the country in accelerating clinical trials, and really the focus on getting site activated as quickly as possible. So our team supports the business compliance and administrative side. So coverage analysis, budgeting, and contracting work directly with sites, but but our work spans and and we coordinate with sponsors, sites, zeros across the process in an effort to do what we can to shorten those timelines and and open the trials as as soon as possible. So excited to join today! 

Jessica Thurmond: 

Amazing! Thank you so much to both of you. We have a ton of experience here. Let’s dive into our topics for today. Starting off with an overview of the current clinical trial landscape based on WCG’s 2024 Site Challenges Report. A lot of really interesting statistics in there. Encourage everybody to read it. I’m going to go over a few of those, but top of mind, 38% of sites indicate complexity of clinical trials as the top issue impacting their research site. I don’t think that’s going to come as a surprise to most people. 35% report that study startup, including coverage analysis, budgets, and contracts are a top issue. Brad, no surprise for you there. 22% report long study initiation timelines. I think everyone is talking about how we can activate trials faster and get drugs to patients in a more expeditious fashion. 78% of sites experience delays due to poor communication, and 65% of sites identify the lack of real-time data access as a significant barrier to their research operations. We talk about this a lot. I work closely with Brad and and some with Pat, and we talk a lot about the issue of trial complexity. And we’ve seen in 2023 and 2024 that that was listed as a top concern for our sites. The only things that really changed from 23 to 24 were a little bit of a decrease in the burden on sites when it comes to staffing, but complexity is still showing up front and center, which really impacts your ability to enroll, to start up studies, your patients. So I want to start out with Pat. What are the primary barriers contributing to the complexity of clinical trials, especially with the integration of the new technologies that go with those. 

Pat Harrington: 

Thanks, Jessica. I mean, that’s a great question. If you look at protocols these days, one of the first things you see is that the number of inclusion-exclusion criteria are growing, even if they try to couch it with you know you know the second inclusion criteria has seven sub bolts or something. It’s becoming much more complex. They’re focusing in on kind of tighter and tighter populations, and some of that has to do with precision medicine and makes a lot of sense. But it’s adding to complexity. Furthermore, if you then you know scroll down through your protocol and you look at the schedule of activities, all of a sudden these tend to be expanding as well, and the number of primary, secondary, tertiary outcomes is growing. Now, couple that with the new technology that’s often being used to capture some of these outcomes, and all of a sudden you have a quite complex trial. And what I mean by that is that, you know, you’ve got sometimes a combination of wearables. You’ve got a patient that’s completing a diary, maybe on their phone using a BYOD bring your own device technology, but sometimes it’s a deployed tablet, and then you have other tablets at the site that you’re capturing electronic assessment information. And I have seen the closets locked, of course, at sites that will will sometimes you know just have stacks of these tablets and you know and they’ve got them all sorted by different trial and you know it’s no longer just internet access that’s an issue, it’s the complexity of doing all this together, trying to time everything in this schedule of assessments with the other you know, teammates at the site, and doing it, and making sure that it doesn’t create an undue burden upon the the patient who’s sitting there, sometimes waiting to make sure that the tablet is fired up, you’ve got the right tablet and protocol pulled up, and the schedule of assessments. So that’s just continuing to increase, and it’s something that we’ll talk more about because there are some ways to get past it. But it’s also something that the sites need to, I think, be able to discuss with the sponsors and even bring in patient advocacy groups. 

Jessica Thurmond: 

Yeah, great point, Pat. I always think about our partners at Florence. You know, have a really great statistic that they talk about. Whenever we have a new trial that’s coming into a site, that oftentimes that introduces around seven technologies that the site needs to engage with to be able to conduct that study outside of the technology that already exists within that site, whether there’s there’s CTMS or things like that. And oftentimes, with the introduction of that technology and the complexity, you know, we think about what that means in terms of actually executing the study, but we don’t always think about the impact that has as much on the startup process of of just getting to the point that you can even put a patient on the trial. So, with that, Brad, what are the main obstacles based during the clinical trial startup phase that you’re seeing these days 

Brad Gruner: 

Yeah, some of it is is is relatively straightforward and direct in the sense that the more complex we see some of these protocols, the larger typically that they are. So increased number of procedures, increased number of arms, and a lot of this work is still managed on some level in spreadsheet in Excel or something similar in a CTMS system, and that just means there’s a lot of a lot more data that’s being managed in that study startup process. So on both sides, you have you have teams, you have people, you have humans that are looking at large data sets, large spreadsheets, and and it just leads to increased opportunity for error, increased opportunity for disagreement. If we’re looking at a budget and and there’s more procedures, more arms, bigger budgets at stake, right? Like there’s there’s more in there, so there’s just a lot more at stake. So so we see more opportunities for either oversight or disagreements between sites and sponsors on on the budget items that are included during the study startup process. We’re also seeing kind of in an indirect level increased complexity. We’re seeing an increased number of amendments flow through the process, and and often even impacting the study startup phase, where there’s amendments that come through in a protocol before a site has even executed an agreement or activated enrollment in that process. So that throws a huge wrench in kind of starty startup workflows that are tough enough to coordinate across all of the different departments. But then when it kind of has to go on pause or get kind of thrown for a loop midway through that process, and you reset and then pick up back with with other documents at different parts of that process, we’re seeing a lot of sites struggle. And I know we talked about it with a lot of our our partners. You’re working on a couple different projects in that area that we have hope to have maybe some industry insight and guidance around, but amendments increasingly are a direct we think output of the increased complexity in some of these trials and that impact on study startup. All of this is contributing, and we’re starting to use this term more internally to the white space that we we see holding up clinical trial startup. So we define white spaces is that aggregate of the time where the work isn’t moving forward in a productive way, whether that’s stuck in an approval process or another handoff where it gets lost in somebody’s inbox. But but that time where somebody’s not actively working on the trial, the increased complexity just increases that white space, and which in turn increases the time to activation for for a lot of sites. 

Jessica Thurmond: 

Yeah, great point. Don’t get me started on amendments. We would talk all day about that if I were allowed, but we’ll we’ll move on from that. We’ve talked about some of the problems, and so let’s shift gears a little bit. What key factors are are you identifying that can drive and enhance success in managing the complexities and startup challenges that our clients and different sites are facing, and we’ll start with with Pat, and then maybe we’ll move over to Brad. 

Pat Harrington: 

Yeah, thanks, Jessica. Well, as a psychologist, I’m going to immediately kind of go to the human and communication side, and it’s really all about making sure that the team has kind of the availability of time and space to communicate that they’re not feeling so rushed and hurried and you know scared if they were to make a mistake or forget something that they they don’t want to you know communicate anything that that suggests they’re not sure what the next step is. You have to create this team, in my opinion, this working team that will you know come together, communicate where things are at, be willing to say I’m not sure what what the next step is here if there is this white space that I’m sure Brad will continue talking about, and what do we do next, and and that’s okay. You don’t have to know all the answers, but you have to be willing to come together as a team. You know, have a leader that’s helping organize all these kind of next steps and and so forth to get things both started up and then to continue on with the trial because you know the startup is one thing, but then you’ve got sometimes very lengthy trials to continue with. 

Brad Gruner: 

I can kind of piggyback off of that in the sense that there’s really kind of very real process implications to the communication or lack thereof. Right, in many cases, the as complicated as something like doing a coverage analysis or analyzing a budget or analyzing the protocol and applying the right costs and fees to a budget can seem like the complicated work. That can become kind of standardized. That can, in many cases, you can establish a clear process for that. And the the nuts and bolts, the blocking and tackling of what to do and how to do it, that part becomes quote unquote the easy part at the end of the day. And the hard part, or where we get held up when we talk about the wait spaces, is kind of in that element of communication of what are the communication pathways if a site and sponsor don’t agree. A lot of times in dealing with a clinical trial agreement or a budget, these are are processes that are happening every day, and the site and the sponsor might go through the same process five times, 10 times throughout the year, depending on the relationships. And a lot of times, it feels like you’re starting from from zero each time. So having the the appropriate communication pathways in place to take advantage of what you’ve learned in the past from working with those partners, and then and then how do you how do you quickly address something so that it doesn’t sit in somebody’s inbox? Because it’s it’s easy, right, for all of us. If it’s if we don’t have a clear answer, just let it sit. Don’t put it at the bottom of the pile. And that’s often what happens. We see your budget. You go to the sponsor, and you have a lot of red lines. They, it’s easy for somebody on the sponsor side to to kind of want to go and gravitate towards the the contract that has the least amount of red lines, right? So, how can you do those little things that streamline and ease the communication between both parties, so that you’re both equally interested in moving forward and and not frustrated and and you’re head against the wall. 

Jessica Thurmond: 

Yeah, absolutely. I mean, I I think one thing from my years as a CRA, traveling to different sites, I learned that you know if you know one site, you know one site, and that’s all you actually know because every site is so vastly different. So let’s take this in a slightly similar direction, but a little bit different. You know, can you share some of the strategies and practical insights for research sites to overcome these barriers and implement effective improvements? I think we kind of talked about process a little bit, but let’s let’s dig in a little bit more there. What what else can we offer people? 

Pat Harrington: 

Well, I’ll jump in real quickly and just say that you know, having very clear processes is what’s important. If you have just have a process, and it may not be a good one, then you can still get messed up, and you run into all of the difficulties that that Brad is is mentioned earlier, including that human element of kind of procrastination, if you’re not quite sure, because you will always find other things to do in a busy site to kind of take up the the time, you know, rather than getting into that heavily redlined, you know, negotiation, for example. So, and I really think that this is where you know having access to quality processes that have been vetted, you know, tweeting our own homework with the VOCA Quality Consortium, you know, can help each of these sites make sure that they’re on the right path. Brad? 

Brad Gruner: 

Yeah, there’s there’s some a couple specific things that we’ve been been working with sites, and and we work with a lot of different sites and and to your point, Jess, not everything works with with every organization. We sit down and we see what’s working and the industry’s changing too, and and things shift and and kind of how sponsors operate and how CROs operate and how sites operate changes. So, right now, what what we’re doing and and really having a lot of success with a good handful of our sites is is making sure if they don’t already have some sort of defined checkpoints in place. Understanding, you know, a lot of sites, for example, are targeting a 90-day startup timeline. So, if your goal is to be executed and ready to go by day 90, what does that mean? Where do you have to be at day 50, and where do you have to be at day 70 in order for that to happen, and and having a very clear process for decision making when you go off go off of that track, right? If if you’re going to push hard for that 90 day process, and and for example, you’re looking at it from the site perspective, and the the sponsor is digging in their heels, and and and you’re kind of at the max of their budget. How do you make sure then that that gets the appropriate internal review, so that you’re having that conversation at day 70 instead of day 180, right? What we find, and we’ve done some analysis with some of our partners, is a lot of the budget doesn’t materially change once you hit a certain point, right? Like you spend a lot of time fighting over very little. So how do you kind of push those decisions up? Have that information because it’s hard to have that have confidence that you’re making the right decision without that information. But then, once you have that information, understand what those critical points are, and and when you when you’ve gotten the most that you can out of that discussion, and make a decision. and And is that enough? Can it support your your financial and and operational needs of that process? And then, and how do you make sure the right people are involved in that process? So we’ve been working to standardize that with our sites so that there’s a packet of information that goes out to the right people at defined time points, especially if if there’s roadblocks or barriers that are preventing targets from being hit. So we’ve had a lot of success with that. It’s it’s reducing. We we pay close attention to the aging queue in our negotiation and what we do, and we’ve seen it have pretty dramatic impacts on the number of studies that are are trickling up beyond what a site we consider desirable in terms of timeline expectations for for supporting an accelerated startup process. 

Jessica Thurmond: 

So beyond the technological and operational aspects, we talk a lot about the business of research. You know what we do on a daily basis supporting our patients, and something I always talk about is kind of what is our north star in terms of why why have we all gotten into this industry? Why do we do what we do on a daily basis? For me, it’s that my mom was diagnosed with inflammatory breast cancer when she was in her late 30s and passed when I was a teenager. And back then, breast cancer was not what it is today. You know, now around 90% of of breast cancer patients go into remission. It’s it’s no longer so insurmountable. We’ve come a tremendous distance since you know my mom’s side. You know of of being in the cancer care space. So I want to kind of shift gears and how significant is the role of human connections and inclusivity in the success of clinical research, I’ll start with you, Pat. 

Pat Harrington: 

Yeah, thank you. I mean, this is really important to me. I mean, as a psychologist and as someone who utilizes scientific epistemology, it’s critical to understand how things work, and in order to do so, you have to be inclusive. Let me just give you a very practical example. It’s embarrassing that we have pulse oximeters that are approved that do not work if your skin is darker. I’m sorry, that’s that to me is pretty unacceptable. And I’ll take it just one step further and try to keep it brief. In that, you know, in order to include more diverse participants, you have to make a human connection with people and get access to you know different groups of people that may have been marginalized and frankly a long time ago. I mean, abused by science, and you know, or not by science per se. Excuse me, but but really by you know clinical trials or other aspects like that, and it’s really important because this isn’t about a social agenda of inclusivity. It’s really about good science, and I’ll end it there and let Brad jump in. 

Brad Gruner: 

Yeah, and and just go to a slightly different direction with kind of the human connection piece of it. You talked about the North Star and and the impact that we all have on the the research space and advancing medicine and and everything that goes into being part of supporting the clinical trial process. That can be hard. Some roles you have that direct connection to right, like you have, you know, coordinators and clinical staff are seeing the patients on the front line, and I think there’s a direct connection, and it can be hard on on you know, we we talk about it amongst our teams a lot, where we’re a part of that process, but not every person in that process feels that or gets to see it every day, right? And so part of it is is trying to find that connection in whatever role you have to stay close to that and understand. and And we’re lucky; we get a chance. Jess and I were just at one of our partners, and and got a chance to tour the the cancer center there and hear a very impassioned speech and and discussion from the leader of that that organization and everything that goes in. So there’s even if you’re not in it day to day, there’s there’s ways that that that can kind of help energize your team, especially if you’re a leader within study startup. We we hear a similar sentiment a lot from from the folks on the study startup side that it can be a challenge to to get connected. So finding different ways to connect with with the group and and and with the overall mission is I think important in order to to to keep a team engaged and all moving in the same direction as it relates to the goals that we’re all working on. 

Jessica Thurmond: 

Amazing, I appreciate that. Well, as we wrap up, I wanted to lead into a final question that I have for you two, and I’m going to give my own tip to start out. But the question is, do you have any final insight or advice for research sites and their sponsors to better prepare for site readiness and improve overall trial efficiency. So I will start out. What I would ask everyone is to explain your why behind what you’re doing. Having worked at sites, CROs, you know, now more at WCG and the service provider side, some FSP with pharma. So often our incentives are not aligned when it comes to what everyone is trying. We all want to get drugs to market faster, and we all want to support patients better than we currently do. But so often we come from a position of defense when we are talking to our partners and our vendors and colleagues, even, and when oftentimes we’re asking questions of our sites and our partners. It’s because we’re trying to understand the rationale behind why you’ve developed your policy or process, so that we can map that onto what we’re doing. And and even from a sponsor end, I would say explain your why. Why have you developed the protocol the way that you do? Why are you collecting the endpoint that you that you are? Because in many cases, that helps the clinic think through their thought process on how their workflow could potentially change, you know, for their nurses or their staff in a clinic. So I think that’s so important, and we lose track of that because we’re so busy, you know, in in this information era. So that would be mine. But for you guys, for Brad, how about you? Any any tips for for everyone? 

Brad Gruner: 

Well, yeah, mine I think flows nicely from what you were saying and is is similar. But maybe to to tie it back again to the study startup process a little bit in in what you were saying there, it’s so easy to go back and forth, or if you’re from the sponsor side to treat the site in an adversarial relationship, it’s a negotiation, right? By definition, in some of the study startup activity, there is an arm arm-length approach to everything, and there is that space that has to be maintained. But it doesn’t mean it can’t be done collaboratively in terms of approach communication. And we often find something as simple as going back and forth via email three times can take two weeks, or you could just call somebody and pick up the phone and schedule time over the next week and get everything hashed out, and to your point, understand why the site is asking for what they’re asking for, why the sponsor is holding firm and can’t pay for something, or whatever that is. It leads to a more collaborative approach. We’ve seen a lot of sites and sponsors take this. There’s, I know, there’s a lot of sponsors have dedicated partnership site relationship type teams where they look to foster those relationships, and we’ve seen the the sites that take advantage of those and and kind of use that time and and have that escalation point. So if something does go you know off the rails or there’s a roadblock that pops up that’s that’s getting everybody’s way, you have another person to go to and and that can look at it and can help move things along. And there’s that consistent kind of again communication pathway to support it. So very similar to to what you said, but I think there are real kind of practical implications where that can save save a lot of time in in the process. 

Pat Harrington: 

I’ll jump in. First off and just say, Jessica and Brad, I love what you’ve said because I think it’s so spot on. I’ll add just one other thing: don’t be afraid to ask for assistance, and that’s from both the site side and the sponsor side. Okay, I’m going to be nerdy site here. There is actually research that shows in complex problems, if a person asks for help, they’re viewed as smarter. Okay, just in case there was fear that was holding you back from asking for help, I think sponsors want to help sites. They want to help them with what’s needed, whether it’s staffing, funding to access diverse communities, you know, whatever it is. And guess what? You know, sites want to help sponsors because it all goes to the the big, you know, the why. I mean, it’s helping kind of humanity as we develop better medicines. 

Jessica Thurmond: 

Awesome! I love that. Well, before we wrap up, Brad, Pat, I want to thank both of you for joining us today and sharing your insights on this episode of WCG Talks Trials, and thank you to our listeners for tuning in. If you have any questions or would like any more information about study startup trial complexity and how we can support you, feel free to visit wcglinical.com. We hope you found this episode insightful and that you’ll join us for future episodes of WCG Talks Trials. Bye for now. Thank you for joining us.