Unlocking Site Potential: Reducing Site Burden and Enhancing Clinical Trial Efficiency

About this episode:

In the first episode of our new podcast, WCG Talks Trials, we are joined by three industry experts, Lisa Ballance from Virginia Commonwealth University, John Musser from Florida Cancer Specialists and Research Institute, and Dan Otap from Genentech, to discuss the topic of overcoming site challenges and addressing site burden.

Listen in as we discuss the results of WCG’s recently published 2023 Clinical Research Site Challenges Survey Report, gain insights from our guests on solutions their organizations have implemented to reduce site burden, and share perspectives on how sites, sponsors, and CROs can work to improve site and trial efficiency.

Speakers:

Episode Transcript:

Sandy Smith:

Hi, everyone. I’m Sandy Smith, Senior Vice President for Clinical Solutions and Strategic partnering at WCG, and I’m thrilled to be your host for today’s episode on the topic of addressing and overcoming site challenges and site burden. Before we dive in, let me remind you to subscribe to our podcast and follow us on your favorite listening platforms like Apple Podcasts and Spotify so you never miss an episode of WCG Talks Trials. We’re joined today by several exciting guests from across the country, Lisa Ballance from Virginia Commonwealth University, John Musser from Florida Cancer Specialists and Research Institute, and Dan Otap from Genentech. Thank you all so much for joining us. Today, we’re focusing on the topic of overcoming site challenges. But before we get started, we’d like to start off with a conversation getting to know our guests a little bit more. My question for all of you is this, how and why did you come to join the clinical research industry? So Lisa, maybe we can start with you answering that question and telling us a little bit more about your role in research.

Lisa Ballance:

So thank you very much. So first, I’ll just say that I’m currently the Associate Vice President for Research Strategy and Regulatory Affairs. Sounds like two things smashed together. In fact, it’s really about capacity. And a lot of capacity is, as an academic site at Virginia Commonwealth University, making sure that we’re lean and that we are intentionally opening the correct studies for our patient population’s needs. How I got into research, and I might be an outlier here, I feel that I actually did this with intention. People often say they don’t know, they’ve landed in research, but it’s about knowledge creation. And most of us have been pursuing knowledge our whole lives. We’ve been trying to make sense of things, and even make the world a better place to try to do some good in the world. And so I think that we are all here somewhat for that reason. I started in graduate school writing grants for grocery money, and I absolutely fell in love with the concept of watch being a part of the world change as an active participant.

Sandy Smith:

Let’s head down to Florida with John.

John Musser:

Hi, Sandy. Thank you. My name is John Musser. I’m currently the Senior Director of Clinical Research Administration. I oversee all the business processes to help our research program. We also partner with Sarah Cannon, but we’re helping to see regulatory affairs, data management, financial startup activities, and then overall strategy and oversight. I kind of fall into that old adage of kind of fell into research. I’ve always wanted to go to medical school, aspirations of being a physician. I kind of fell into the world of research administration just by chance. I’ve always had my love of sciences. And then I found this is a way I could help society and use my strengths to give back and find new and better therapies for our patients.

Sandy Smith:

Fabulous. So clearly, Lisa representing the academic community, John representing community-based sites. And then we also didn’t want to leave out a sponsor perspective. So Dan, welcome.

Dan Otap:

Hey Sandy, thanks again for the invite. So my story probably is akin to the bell curve in research, right? So I was in my graduate degree in New York City, newly married, and needed the pay rent. So I ended up getting a job as a research study assistant at Sloan Kettering, entry level position. And it suited my mindset, it suited my skillset, and really just started to create a career from that moving forward. Looking at my career trajectory, starting at the site side, moving my way up to associate director of regulatory affairs at Columbia, and then executive director of community practice research at City of Hope. And now, I am in a role that I love at Genentech in their gRED division, which is their early phase in early clinical development group for protocol and study management. And I focus on alliance work and relationship management with sites and our other internal stakeholders at are company.

It’s a global position. I’m based in Northern California and my job ultimately, and my division’s job is to make sites and investigators lives easier. And I wouldn’t have it any other way. So I guess I fall into the camp where I fell into it, and it just worked.

Sandy Smith:

Fantastic. Well, again, just so pleased to have all three of you willing to share your experience and expertise with us. So in the first quarter of this year, WCG conducted a survey where we reached out and surveyed over 500 US research sites. We asked about their perspectives on the major challenges they’re facing in conducting research, and solutions that they’ve implemented. And of course, our objective was to understand and gain insights that we could share across the research community with other sites, with sponsors, CROs, and even service providers, all of this to all ultimately help deliver trials more effectively. The folks that responded to the survey included individuals in research administration, CRCs, clinical research nurses, those working in IRB and regulatory roles site leadership, but also included a fair number of investigators. I’d say the majority of our respondents for those in research administration, as well as the CRCs. About 40% of them were from academic medical centers, and the remaining worst sites representing physician practices, site networks, community hospitals, as well as independent sites.

So let’s dig into what we found. So as we’ve done these surveys for the past three years, we’ve seen staffing and trial enrollment as the biggest concerns. This year was no different. Staffing and retention, 63% of the respondents ranked that as their biggest concern. Trial enrollment came in second at 48%. As a result of our interactions with sites, we heard a lot about trial complexity being an issue, an impediment to opening trials. So we actually added that into our survey in 2023, and found that it was ranked third at 36%. That was tied with study startup activity. I think of additional note is another one of our questions was, have these issues impacted your site’s ability to open trials? And 52% of the sites reported that it did. Now, I’ll also mention that as we use WCG’s data intelligence platform, we can tell you that in 2022, over 3,300 sites in the US only opened one clinical trial, and under 50 sites opened 50 or more trials in 2022.

So I’d say we saw an overall constraint applied in 2022 to sites and their ability to open trials. So now I’m going to go to our experts and ask the question, does this data surprise you, and what impact have you seen at your site or maybe other sites that you work with. Lisa, can you kick us off for AMCs?

Lisa Ballance:

Absolutely. Thank you very much. To tell you the truth, it really did surprise me, specifically the 3,300 sites only opening one trial in 2022. What surprised me most about that is that even running one trial, the training that you would need to have the software capabilities, just even your enrollment practices, that’s a lot of infrastructure. And I feel that for a site that does a larger number of studies, that these things are things that you need to invest in going forward in order to remain nimble. So it did surprise me, and I’m curious if that would be a trend that we would lose our small sites. For us, we actually saw the increased complexity of the trials. We have seen more data points and we have seen longer trials, lengthier trials with more procedures, and this has impacted our startup times. So part of the issue is we do a lot of trials that are standard of care, plus procedures that are research only. Even just adding complexity to the coverage analysis process can create some delays.

We’ve also, as we’ve adopted the new common rule, and I’m very curious to know how this has impacted other groups, but we’ve had to address single IRB issues. So we’ve had to really ramp up our process and become much more flexible in that space. We have a community now who understands what the new normal is, but I would imagine that would be very difficult for smaller sites. I’m curious what the others have to say.

Sandy Smith:

Yeah. John, maybe you can give us more of a community-based perspective on this data.

John Musser:

Yeah. That was one things that was brought in to do, is to help improve our technology solution stack. It’s something that you probably saw more AMCs invest in earlier on, and some definitely during COVID started to do a little bit more investing. But it pays off, and we’re seeing some of those. However, one thing kind of a hindrance is sometimes sponsors do have their solutions, and they’re all different. And so now, we’re trying to keep track of all these different pieces. So it does hinder its operations for these clinical studies. We’re seeing more patients than we ever had historically. Florida Cancer has I think over 3.3 million visits this past year alone. So there’s an opportunity there to see more patients and improve the outcomes for as far as clinical trial participants, but we’re just not seeing it right now.

Sandy Smith:

Thanks, John. Dan, let’s go to you for a perspective of a sponsor.

Dan Otap:

Yeah, so absolutely no surprise, in my opinion, right? So complexity and acuity have been top of mind related to everything from resource management, proactive annual study, staff projections, and now more than ever incorporated, especially in cancer centers, into their feasibility review, their disease review, group considerations, et cetera. Then interestingly, that said, we also see data coming out of Ken Getz’s team from Tufts in the CSDD as recent as 2020 threes paper on protocol design and performance benchmarks. That complexity continues to climb across protocol design variables. So for instance, your phase two and phase three trials, average 20 endpoints or more per study. And to your point, Lisa, 2.1 million and 3.5 million data points collected across phase two and phase three trials respectively. That’s mind boggling to me, and it’s data driven. So this clearly has downstream effects on site’s abilities to both conduct their ongoing studies, as well as open any newer studies. It is definitely something that is top of mind across the industry. We know that it exists. We’re trying to bridge that gap to both maintain scientific rigor while also becoming more pragmatic with our approach to studies.

Sandy Smith:

Yeah, you’re right. So certainly, we hear a lot about trial complexity. And I know there’s lots of conversations going on about how we reduce the number of exploratory endpoints, how can we stick to just needed data? So a lot of work to be done there. So I’d like to… Lisa, you brought up a great point about trends, and so I always like to look from year to year. So when we compared this year’s survey to 2022, the perceived additional burden of remote monitoring seems to have significantly reduced. It was ranked at 34% last year down to 9%. And while we know that, many, many sites continue to work on trial activation timelines. They’re looking at process and workflow improvement, those are just ongoing activities. Another area that stood out of high concern was technology. And John, you brought that up ranking higher this year at 18% versus only 10% last year. So I wonder, Dan, if we can start with you maybe from a sponsor perspective. You mentioned about sponsors providing technology. John talked about sites embracing technology, but then also this unusual, I think decrease in the perception of burden on remote monitoring.

Dan Otap:

I’m actually relieved and encouraged to see the data around remote monitoring. I see it as a maturation of the process and indicator of overall implementation and adoption actually. But now interestingly, technology continues to climb as a burden, surely due to the level of innovation in this space, outpacing end user informed experience and feedback. That’s just my opinion, right? You see this with the low-hanging fruit of single sign-on methodologies, right? API integrations across platforms, et cetera. The take home here in my eyes is as sponsors, we have a responsibility to take site staff and patient experience and operationality, if I can use that word, into consideration when vetting new vendors and deploying new tech software solutions. We need to be intentional about both the upstream planning, as well as the downstream process review so that we can continue on to improve in this space. Remember, it’s just like Apple with the iPhone. Tech’s biggest selling point is ease and end user ease. So we need to keep that top of mind and ensure that the return on investment is seen.

Sandy Smith:

Thanks, Dan. Lisa, how about your perspective on remote monitoring? We heard a lot of concern that what we were able to accomplish during the pandemic was noteworthy. Let’s not lose the knowledge gained. How do these stats resonate with you and the work you’re doing?

Lisa Ballance:

So we recognized right away that this was frankly an area of risk for us. We want good monitoring. We want to have great relationships with our sponsors, and we want to make sure that we have the big picture when it comes to multicenter trials. So while we did limp along quite a bit during COVID, we have invested in a tool that facilitates fully remote electronic monitoring. We realized that not only did we need to make this investment for the safety of our entire program, the security of our program, but also because we view the workforce issues that we have faced, largely connected to needing to be more nimble, needing to be more flexible. And the same functionality that we get through our electronic regulatory system that facilitates remote monitoring also facilitates sending an alert to an investigator that there’s a new patient who’s interested in a study.

It makes us nimble in ways that are beyond the monitoring piece. But I feel like if we had not made that investment when we did, and also utilizing the single on, making sure that it was easy for the end user, I fully believe that the issues that we faced with retention of staff would be even more difficult.

Sandy Smith:

And John.

John Musser:

Yeah. I came on board just last year, but you’ve seen adoption of a couple different systems. And now there’s about to be roll up even another system. And as Lisa said, the single sign on is a nice tool to have. It’s going to allow a little bit simplicity for our investigators who are hoping to have one less system to log into, remember a password. And so life has definitely gotten a little bit easier. However, we’re kind of happy, at least I am, to see a little bit of return to onsite monitoring. We’ve had some sponsors reach out to us. As alluded to earlier, you kind of miss that good relationship you have with the monitor. It really does help ensure there’s a good communication flow. And while we understand the remote is here to stay, the combination of both, I think is needed to ensure proper compliance and monitoring.

Sandy Smith:

So we know the pipeline for trials is rich in many therapeutic areas, oncology being one of them, and we’ve witnessed site capacity issues over the last few years. One of the things that contributes to site capacity is the availability of investigators and time for physicians to serve as investigators. So it’s something that we at WCG have been tracking for quite a long period of time. And as I looked at the data over the past five years, we’ve seen a steady decline in the number of US-based investigators. So back in 2018, we had just under 18,000 investigators. And when we ended 2022, we were down to about half of that 9,300. There was one slight increase. And that occurred between 2020 into 2021 where the number only went up about 4%, and that was likely due to all of the effort and interest in helping to address our public health emergency. But then we went through a very significant drop after that in 2022.

And when we included this issue in the survey, one-third of the sites responding to the survey reported that physicians had less time, less availability, and/or less interest to conduct clinical trials. So Lisa, I’ll start with you. Your perspectives at an academic.

Lisa Ballance:

Let me just say that I have often seen some ebbs and flows over time, but this has actually gotten to a point where if we don’t have more physician researchers, we will be in crisis. For VCU, that means that we are investing in pipeline programs to bring more people to the table as clinical and translational scientists, but we also need to be looking outside of the box, if you will. We have PhD prepared nurses who are very active researchers, and I see opportunities throughout our program to actually create a little bit more of maybe a horizontal approach to what is an investigator responsible for and who should be the principal investigator. So maybe there is a different perspective. Maybe we need to be looking at what does it mean to lead a clinical trial? And how can we best meet the needs of the potential participants by providing the right person at the head of that.

Sandy Smith:

Excellent thoughts. And John, we all know that there is definitely a desire for people that are being treated for cancer to get cancer care close to home. Obviously, we know that in oncology, research has always been considered a treatment option for many disease states, but we also recognize that in very busy medical practices, there is a perception that research takes more time. How are you seeing that play out in the community?

John Musser:

We’re glad some wonderful physicians who are actually interested in research. We always want to do our best to make sure that research is not a hindrance or a burden to our investigators. We know it takes that time. We want to make sure our people are properly trained, that are supporting them, they feel they have the support to be successful and the patients that are going to get the care they need.

Sandy Smith:

And then Dan, coming to you, you sit at a really interesting position because you’re working with these early phase sites, which are complex trials. And as we said earlier, some sites have reduced the number of complex trials that perhaps they were willing to open. And then we have this data showing investigator availability could also be contributing. Have you seen this impacting timelines to get studies open?

Dan Otap:

So it’s a really interesting juxtaposition, right? And it resonate with John’s point and Lisa’s earlier points about trying to incentivize investigators, especially community investigators to be more involved. It does take more time to do research. And the early phase setting. It is unique. You have to do a lot of things at a larger AMC, especially due to safety profiling, et cetera. The interesting thing here for me is, and you brought this up, Sandy, the concept of clinical trials is best standard of care for oncology, right? It becomes harder once you step outside of that kind of acute oncology type disease setting. But that said, PIs and investigator interest in time and availability will become even more of a consideration as we see an increase in the realization of work in the space called diversity, equity, inclusion, and access, right? So if we’re truly going into that space, this is going to become even more relevant and salient. I’m encouraged by groups such as ACCC, ACRP, ACI and others taking this concept of training new investigators into account, and clinical research staff, and kind of putting that as programmatic initiatives.

Here, we are at an inflection point in this industry where we have to have new investigators developed, we have to have staff developed or we’re going to have a dearth of opportunity.

Sandy Smith:

Indeed. So we want to be solutions focused in this podcast. And our respondents to the survey indicated a number of approaches to addressing these challenges. And again, as a reminder, staffing retention, and hiring, trial enrollment, complexity of trials, and trial start activities were the top four. Some of the approaches that they mentioned to address these challenges were hiring additional staff. We also have heard that a lot of individuals that are filling new vacant positions, those individuals may be coming in earlier in their career than perhaps the folks that have vacated those positions. So training, maybe taking a little bit longer. And some sites are actually designing novel training programs to increase the number of research professionals that are available. Technology clearly identified as a enabling solution to the capacity issues, and then even partnering with research services providers. So we’ll start with John this time. Can you talk a little bit maybe high level with what you see as the most important solutions that may benefit sites that are dealing with the issues identified in the survey?

John Musser:

I think it’s not to be the people. So it’s hard to sometimes feel like we’re seeing the great resignation. You did see it slow down a little bit. We were fortunate to be in Florida where a lot of people did move to, so we’ve been able to identify some candidates. As you said, that maybe they didn’t have the training app or the research experience, so we’re having to revamp our entire training regimen to make sure we can find a really good candidate and then keep them here and then train them. I think also you have to make sure, and I know it’s a overused word as far as the culture, but people got to feel that they want to stay at that location, especially in community setting. There’s a close relationship with your investigator there, as well as the leadership across the state for our organization.

So I think as you kind of get down and make it more of a person-to-person relationship, that’s going to go a long way, and then make it easy for them, as you said, for the enablement. And then as for those scenarios where you’re unable to find those people partnering with the right research service to augment what’s out there. So whether it’s data management, financial management, budget, contract negotiations, sometimes if you just can’t find those people or you don’t want to settle on just putting a person in that role, so it might be best to find someone out there. And that’s what we’re looking at doing.

Sandy Smith:

Yeah, I think one other statistic I want to note from the survey was that non-academic medical centers, they reported higher rates of staffing concerns, actually 74% versus the AMCs, which was just over 50%. But I also latched onto your comment about the sense of community that sometimes gets created in a community-based practice. And what we saw was for turnover rates, they were actually lower at non-academic centers, so very much consistent with what you’ve said. Lisa, let’s go to you for solutions that you see as addressing these top concerns and burdens at sites.

Lisa Ballance:

Yeah. So thank you. John, I thought you made a very good point about you really need to think carefully about where you prioritize your investments. And when we look at… I guess this is a fundamental perspective. We are asking ourselves, what are we in the business of? And I’ll just give you an example to this. When we talk about our clinical research and clinical trial program, are we in the business of training staff from the ground up and staff recruitment strategies? Well, we’re not a staffing agency. And one of the things that we have found incredibly beneficial is to turn to the experts. When it comes to staffing for peak times, this is where it’s incredibly valuable. We have used external partners for contracting contract negotiation, budget development, coverage analysis. Frankly, there’s no other way to handle some of the peak times that we have experienced without being able to lean on these partners.

From a startup perspective, I will say that, leaning in again to some experts in the field who are outside of our organization, we now are no longer reactive. We can be proactive and watch pipelines, make sure that we have the right expertise. It’s helped us to make more data driven decisions, and also prioritize. So for us, that has resulted in a lot of reeducation, as I mentioned earlier, with our research community. While we lean in and develop those relationships and try to solve problems to make engagement in clinical resurge and the activating clinical trials smooth. So I honestly would love to watch this trend going forward. We have had great experiences and I think it’s reduced a lot of the stress with pipeline management for our teams.

Sandy Smith:

Well, John and Lisa, you shared some great solutions, so I’m going to turn to Dan now. As a sponsor, what do you see as working?

Dan Otap:

So when I read this WCG report, you distilled 10 ways that sponsors and CROs can help with address key site challenges. And I’ll tell you as I was reading it, I basically was fist pumping, meaning it’s spot on. So when I look at what came out of this, a couple points that were really relevant to me were number three, set realistic study startup timelines with the sites conducting your trials, number four in your report listed work to simplify and streamline the feasibility process for budgets and contracts. Number six was very relevant to me, on a personal level, identify site-specific needs and provide personalized support for each site, whether it be through a process or people or technology. List goes on. And from a site and sponsor relationship perspective, everything rises and falls on full frank and open communication between those stakeholders.

In my day job, I serve in a variety of capacities, like all of us on this call and all of us listening. But perhaps the most important to me is the site alliance activity and the site facing work that I engage with in gRED our divisions develop an entire infrastructure based off relational value delivery to our end customers, which are our sites and our patients, period. Our global relationship management network engages stakeholders and infuses feedback into process improvements on our clinical operations side and day-to-day study, team execution level interactions. Communication, again, is key, and the relationship aspect is vital, foundational and critical to ongoing positive and productive collaboration, in my opinion. I think your suggested recommendations for sponsors and CROs resonates with that, and I was very pleasantly surprised when I read it.

Sandy Smith:

Well, thanks for that perspective. So as we draw to a close for this podcast, I’d like to ask each one of our panelists for one final thought, observation, or recommendation to address site burden.

John Musser:

I really do love technology. I continue to push that solution as a way. And also, the transparency on the data, as Lisa also alluded to, is making sure we’re using all the information we have at hand to make data driven decisions. So if it’s making sure we’re hiring the right people or we’re seeing turnover rates in certain areas, what can we do to make sure that’s being mitigated? Are we opening the right trials? Are we closing studies that weren’t a good match for us? And then also, as Dan just talked, you need to have talks with your sponsors, CROs. You need to let them know the pain points, and not just later on when it’s a monitor visit. You should be able to pick up the phone and have that conversation with them right then because if you’re having that issue, more than likely another site’s having that issue, and it needs to be communicated out. And then also understanding what’s driving all of this as the patient and making sure that everyone remembers that at the top of focus.

Sandy Smith:

Beautiful. Some great key summary points. Lisa, final thoughts?

Lisa Ballance:

Yes, so that’s hard to follow because those are very, very good. I’ll just add to it by saying that we have just now started to really focus our attention on patient participant engagement. And hearing from our participants in clinical trials about what, like what they’re looking for, it would be a shame to fix technology issues and to find out that parking was the main problem. So I would say that we should also be asking our participants, where are the pain points that they see that really limit the progress of clinical trials?

Sandy Smith:

Well said, Lisa. Dan, bring us home.

Dan Otap:

All right, tough acts to follow here. I sometimes am a very simplistic minded thinker, and for me, if you asked me what the biggest solution would be in all of this, whether it be tech, whether it be patient informed and developed protocols and vendor solutions, is the concept of putting the other person first. If I sit myself in a situation and I’m developing a workflow for a site or a vendor’s developing a solution for an end user, or the site’s trying to develop something for their patients, or vice versa and all back and forth, if we put another person before us and think and empathize with that scenario at all times, we’re going to find creative solutions. As simplistic as it sounds to me, the best solution is consistently putting the other person in that scenario face forward, and trying to think on their behalf what works best for them.

And once you can identify that and develop the process or the workflows or the software solution or the vendor solution for transportation, et cetera, we’ll get there. But I think it all begins with the simple phraseology of, you’re more important than me, and what can I do to make your life easier?

Sandy Smith:

Love that. Don’t forget some of the simple things. Well said. Well, thank you so much to John, to Lisa, and to Dan for joining us today on this episode of WCG Talks Trials. And thank you to our listeners for tuning in. We hope you found this episode insightful, and we hope you’ll join us next time on a future episode of WCG Talks Trials. To access the report that we’ve mentioned during this podcast, please go to the WCG website at www.wcgclinical.com. Thanks so much, and bye for now.