Watch part 1 of our 3-part webinar series where we dive into the challenge of participant recruitment and retention at clinical research sites and discuss how this challenge impacts all clinical trial stakeholders: sites, sponsors, CROs, and participants.
Key Takeaways:
- Staffing and Retention Are Critical to Capacity. Workforce shortages and turnover strain sites, especially with over half managing more than 26 trials and a quarter handling more than 150 simultaneously. Reliable retention strategies and cross-trained teams are essential to maintain capacity and meet timelines.
- Protocol Complexity Extends Trial Timelines. Phase II and Phase III protocols now average 263 procedures per patient and support 20 endpoints, with Phase III data collection points increasing 300 percent in 10 years. Trials now take 10 months longer to complete, making early feasibility assessments and streamlined designs critical.
- Amendments Add Regulatory Pressure. Over 75 percent of protocols require at least one amendment, with Phase III trials averaging 3.5 per protocol. Each triggers ethical reviews, consent updates, and re-consenting. Clear, repeatable processes help sites manage these changes efficiently.
- Fragmented Technology Slows Teams Down. Sites rely on disconnected, single-purpose systems, forcing staff to juggle tools and increase training fatigue. Prioritizing interoperable platforms reduces inefficiencies and allows teams to focus on critical tasks.
- Enrollment Overwhelms Resources. Enrolling one patient triggers scheduling, engagement, data entry, query resolution, and documentation, often outpacing site resources and stalling further recruitment. Planning ahead ensures enrollment momentum doesn’t become a bottleneck.
- Recruitment and Retention Depend on Real-World Barriers. Strict eligibility criteria, travel costs, long distances (up to 500 miles for rare disease trials), and provider hesitancy hinder recruitment. Addressing these barriers improves enrollment and retention.
- Site Capacity Demands Role Prioritization. Many sites lack enough staff or specialized skills to balance tasks like pre-screening and data entry. Aligning roles to strengths and protecting time for key responsibilities helps small teams deliver consistent results.
Download the presentation slides below:
Transcript:
Sandy Smith:
Hello, everyone. Thank you for joining us today for our WCG Site webinar series, “Thriving in Clinical Research: Overcoming Common Challenges as a Site. Today is going to be the first of our three-part series. We’ll be focusing on participant recruitment and retention. And thank you again for joining us today. So my name is Sandy Smith. I am senior vice president for clinical solutions and strategic partnering at WCG, and joining me are my colleagues Seth Halvorson, general manager for Site Solutions at WCG, and Shelby Ward, manager of Site Services for WCG. Today, our agenda is going to be talking about some of the WCG 2023 Site Survey data, as well as a few market trends. But really, the bulk of our presentation today is going to focus on recruitment and retention, with a special focus on the participant pathway, including a couple of tactical looks at identification, and of course, we always welcome your questions. Now, we did receive a number of questions from those of you that registered and submitted questions at that time. Seth and Shelby have reviewed those questions and incorporated them into many aspects of their presentation. However, today you still have an opportunity to ask questions, so we ask you to use the Q and A function, and we’ll get to as many as we possibly can. So the WCG Site Challenges Survey report is available to you as a total electronic document by going to our website at wcgclinical.com and in there you’ll find the complete survey information from our polling of over 500 clinical research sites that was conducted in March of 2023. Stay tuned. We will be updating it in early 2024 as well. But in addition to the survey results, you’ll also see recommendations for sites, sponsors, and CROs to help try to reduce the site burden and improve trial efficiency. That, as well as this presentation, is really aimed at trying to bridge the connection between the day-to-day operations at a site, as well as the objectives of the CRO and sponsor, as we say, we’re all in it together.
So let’s take a look at some highlights from the 2023 Site Challenges Survey report. First of all, we said we surveyed over 500 sites, and you see the breakdown of who responded to the survey. About a third of the respondents were administrative staff at research sites, and we had about a quarter of them were clinical research coordinators or clinical research nurses. But there were also respondents from specialized functional areas such as regulatory teams, site leadership, and also included principal investigators. As we look at what sites they originated from, 39% of them were from academic medical centers, and then we had 17% were from physician practices. But there were other types of research sites, as noted in this slide and in the report, but what was of interest is the volume of trials that these sites were managing on a day-to-day basis. With over half of them responding that they were operating more than 26 trials, but as you can see from the data, about a quarter of them with over 150 trials going on at a given time, and this is really the result of their information telling us what were the top issues that were impacting them. So clearly, workforce issues with staffing and retention has been an ongoing theme for the past few years. But where we’ll focus today is on patient recruitment and enrollment. This is one of the leading challenges for sites, with almost half the respondents identifying it as one of their pain points.
As we go on with the webinar series, we’ll be addressing some of these other areas of interest. But today, we’ll focus our comments on patient recruitment and enrollment, and then break. this down between academic medical centers and non-academic medical centers, again the top concerns are really fairly the same. A little bit change in order, maybe for study startup and complexity of trials, but certainly the top four remain the same. And it looks like enrollment issues had maybe more of a challenge at the academic medical center site than the non-academic medical center sites, but really not by significantly much. But still maintaining that number two spot in terms of the biggest challenges. So we talk a lot about site burden and to share some of our trends with you on the challenges that you’re feeling with not having enough time that’s impacting capacity. We wanted to talk a little bit about the impact of amendments on clinical trials. More than 75% of clinical trial protocols require at least one substantial amendment. So you may ask, what’s a substantial amendment? Well, it’s one that the sponsor needs to approve. It’s one that needs to go through ethical review, also requiring informed consent changes and reconsenting of the research participant. So that’s a lot of additional time. When we look at phase three research that have had these substantive amendments back in 2015, there were only 66% of the trials. Fast forward to 2022, now 82% of those phase three trials have an average of three and a half substantial amendments per protocol. Again, think of all the regulatory work that we talked about having to go through with ethical review as well as re-consenting, and when we look at phase one protocols, those increased by 15% So clearly, amendments do add to site burden, and site burden can have an impact on recruitment and retention.
The other area I wanted to highlight was that of complex protocol designs. We know there have been a lot of discussions happening with sponsors, with the FDA, with other regulatory agencies about the complexity that we’re experiencing. There’s good data that come out of those complex trial designs, but when we begin looking at the burden on not only the sites but on the individual participants, that becomes a concern. So this data from Tufts shows an average of 263 procedures per patient in phase two and three protocols, and those supporting approximately 20 endpoints. So not only the burden on the individual research participant, but then too lots of data collection points. And Tufts reported a 300 percent increase in data collection points in phase three trials over a 10-year period. So with our current staffing shortages, capacity demands, and challenges with meeting trial enrollment. What we have seen is it’s an average of 10 months longer to complete a clinical trial in 2023 as it was in 2018. We understand too this may have an impact on your ability to open new trials as well as recruit to your existing trials, and then my last comments will relate to decentralized components that are part of clinical trials. We certainly see a large volume of trials that are operating in this decentralized space. Some will call it hybrid trials because rather than calling them fully decentralized, they have some element or decentralized component. But look at the staggering number of individuals that are needed to complete those trials-4 million-and where are those trials occurring? In what therapeutic areas? Well, largely in the neurosciences, you see CNS tops the list with mental and behavioral health coming in second, but oncology, metabolic diseases, cardiovascular. You’re seeing trials across all TAs that have some element of decentralized components. This too is perceived as having another impact on psych burden and certainly recruitment activities and recruitment tactics may differ, but we’ll wait to hear from Seth and Shelby on that.
So now, as we turn to our topic of the day, I would like to start with a polling question: What is your biggest challenge related to participant recruitment and retention? And we’re going to ask you to pick your biggest one, so this is just a single choice. We’ll give you all a moment to reply, and then we’ll share the results. So your options here: protocol challenges and eligibility criteria, study timelines, experience recruiting, informed consent challenges, the number of study visits, competing study priorities, experience recruiting diverse populations, keeping patients retained, or maybe something else that’s not on the list. Okay, certainly the protocol challenges and eligibility criteria far outweigh all of the other options, and if we scroll down a little bit, as this is a long list, we do have a fair number of others there. Well, fantastic! Thank you all for sharing your opinions and experiences on this, and getting into our content for today. I’m going to turn this over to Shelby.
Shelby Ward:
Great, thanks, Sandy. Good morning, everyone. I hope your Halloween is off to a good start. And if you do not celebrate, happy Tuesday. Nice to speak with you here today. So, jumping off from the recap that Sandy had provided from our survey results from the site poll that’s done earlier in the year, I’m going to start off just by reviewing where our site support has been primarily utilized by sites just in the last three years. So covering a distribution, as you can see here, of over 2,500 sites supported in the last three years, we can see from this graph that support for recruitment and retention are primarily where the greatest needs were for our support. Retention you can really think of in kind of two categories. The first are going to be those patient-facing responsibilities, such as conducting study visits, follow-up with your patients. But there’s another just as critical piece to patient retention, which is the corresponding data and documentation requirements that we know go into that as well. So you can really factor in the documentation and regulatory category as well as data entry with retention, as you see here. So moving forward, we’re going to be covering many of the key concepts that you need to keep in mind when understanding how to operate a study within the balance of the study and the sponsor priorities by understanding the challenges that a site may face with recruitment and retention, it can better inform the design of the study, allow for you to proactively align on any complex processes that may need to happen for the eligibility criteria, and ultimately create a more seamless experience to patients who are raising their hands to participate. As Sandy noted, we did incorporate many of the questions that you sent ahead of time into the slide deck, so you’ll see that kind of pop through. Thank you for sending those, and towards the end of the slide deck, we’ll also have time for some additional questions as well.
Seth Halvorson:
All right, so thank you, everybody. Thank you for attending today. I would like to start out by hitting what Shelby was just talking about overall on the recruitment process and grounding into how we think about recruitment and retention overall. We think about recruitment and retention as the participant pathway. This is really that time when the individual is identified, enrolled, conducts the visits, retains in that participant retention as Shelby is talking about, and then has all the documentation that is generated from those visits entered. This query is resolved, etc. This and when you think about it, you need to think about it as an overall integrated holistic approach. This is everywhere where that participant is touching that study, all think about it, and we’re going to talk about it and break down these concepts you see on the on the slide right here. We can break it into component parts to talk about it, but you need to think about it overall as integrated, and that’s going to be a theme throughout.
So if you start on the recruitment side of it, recruitment is identification again, finding the individual that might be eligible for the IE criteria, locating that individual. We’ll talk about different ways and how that’s done in a second, and different processes. Enrolling them once you’ve identified them, bringing them into the study, informing the study, educating them on the study, going through the consent process, getting them to ultimately where they are then enrolled, so that you can retain them, so that then at that point it’s the study visits. This is the time when the study visits are conducted. You’ve got the outreach of the individuals. You’re keeping them engaged. You’re also managing all of the data and all of the queries that are generated as a result of those study visits, and you need to make sure that all of that is conducted as well because ultimately that’s what’s submitted at the end of the day. So when we look at this, it’s a process and it’s a fairly simple, straightforward process when you think about it and you can break it down. And we do as much as we can to make break things into playbooks when we think about it. If then’s to try to simplify it. So then the question remains: if it’s this simple, then why is it continually a challenge? Because it’s continually a challenge, and it’s not just a challenge pre or post pandemic. It was pre pandemic and forever. It’s always been a challenge, and when you think about that and why it’s a challenge, it’s because we’re talking about people. So at the entire process that we’ve talked about. You are enrolling and identifying people. These are people who have interest in learning and participating about something that’s impacting their health. So these people are invested. They are focused. They are concerned, and that takes time. You’re looking at people who have lives. They have a story. There’s something that’s going on in their world. They’ve got commitments. They’ve got obligations. You are bringing somebody and asking them to come in and participate in a study. Yes, they’ve got motivation, perhaps on an indication, but you’re also asking them to take time and the energy away from their everyday life to complete and participate in that study. You’ve got to account for that. That’s got to be part of the overall thought when going into this, and when you introduce people, you are introducing complexity. You’re introducing infinite variables to what is otherwise a straightforward process. We’re not talking about widgets. Again, we want to really just hammer that home, and I know that’s clear to everybody in this call. Everybody who is participating in this webinar or on this webinar is participating in trials and knows what we’re talking about. When you’re talking about people and individuals, you just keep adding more variables to it.
So, at the sorry, learning to get these new webinar slide controls here. It takes time to properly interact and manage people, and it should. That’s appropriate. We all have a duty. Everybody who’s in clinical trials and everybody who participates in research has a duty and an obligation-a sacred duty and obligation-to make sure that that participant is taken care of that entire way through. Which is why we look at it so clearly in this approach. Another aspect on this is clinical trials are not transactional; they’re not. They’re at the core. Again, talking about people and talking about their health, we’re talking about things that are going to change those individuals’ lives overall. And you’re talking about people who may already be coming into your clinic, or coming or become into your clinic because of the trial. You know these people. These are people who are you’re interacting with on a day-to-day basis. It’s not a number on a spreadsheet. It’s not an individual. It’s not abstract. There’s a person and there’s an individual who is undergoing that clinical trial that you know of. So you, it’s when you look at the processes and the steps that it takes to conduct everything, it gets magnified exponentially when you look at it in a non-transactional aspect, and you look at it as the lives that are being impacted. At the end of it, all the investigator and the study team are accountable, as are everybody who’s participating for each of those individuals, and we’ve got to think about the clinical trial process overall as being transformational. So, a lot of what gets reduced to, and we do, we will we will reduce the conversations and say we’re looking at X number from a referral source. We’ll talk about it from different ways, but at the end of the day, we’re talking about bringing people in to find out and learn something about a process that will help potentially their health and change their lives. We’ve got to think about it from that capacity.
So here we get to our first question. So the first question is, how can sponsors come in and how can they build an open communication line with sites? This is an area that we are especially focused on trial first. The trial has to come first. So if you’re looking at how to build an open relationship with sponsors and sites, if everybody can think of this continually as the trial and the trial’s outcome is the goal, then we can work very effectively on how to get to that goal. This isn’t a question about, you know, there are multiple ways where this can come across, and it can seem almost like there’s there can be a friction between it. There doesn’t need to be. If the ultimate goal at the end is making sure that there are participants that are eligible, who are qualified, who go through the process, who are able to attend the visits, and they’re retained. We all are in agreement on that. That open, clear communication to get to that goal becomes actually pretty easy. It actually it becomes, I think, is very effective. Remembering the trials are not transactional. Remembering that they’re transformational. Remembering that it takes extra time to do a lot of these things is key. We’re going to talk about this in a second. Is understanding the referral source contribution potential, and we’ll get into detail. But this is an area where communication can become critical. Is we make assumptions at the beginning of a trial as to where we believe that we’re going to identify those individuals, and where we believe that those individuals will come in from. Those are never right. So let’s all just agree that we’re going to have a change, and then we’re going to make an adjustment. There’s going to be a pivot. You can make a good guess, but clinical trials are not. If we had a crystal ball, that would be fantastic. You’re going to make adjustments. You’re going to make changes. You’re going to make pivots. And if we acknowledge that going in, now everybody is making sure people’s best efforts are there, and we’re having open collaboration, so we know what we need to do to go forward and achieve the ultimate goal.
Shelby Ward:
All right. So jumping off from that point, that trials are not transactional. Understanding that trials are not transactional helps us to not underestimate the work that is required first and foremost. You can’t have a study without participants, right? So that All ‘s the tip of the iceberg. When a study is initiated, the primary goal is always going to be to enroll the study, and that itself can be a very transactional point of data requested, data provided. It’s important to recognize that every patient that a site is able to successfully enroll is also going to trigger a cascade of responsibilities that ultimately that study team is going to need to balance for the remainder of that study. In some cases, this can be many years. Here we can see an example of a patient enrollment. We stuck with the Arctic theme. If you’re like me and you’re in Minnesota this morning, we got our first dusting of snow just in time for Halloween. So this seemed especially fitting. It’s like we did have a crystal ball in this case.
So enrollment is the milestone for the study, and it’s what most observers are going to be watching out for. But just like an iceberg, there’s often that more to meets the eye than just enrollment when it comes to a study. All right, so here we can see that there are many other activities just below the surface that are involved when you are enrolling a study in a patient into a study, it also includes a lot of those retention aspects as well. This is by no means an exhaustive list of the responsibilities that a site needs to manage when a patient is enrolled into a study, but this picture does symbolize that there are a wide array of processes that need to be managed well going forward in order for them to be able to successfully retain this patient in the study, collect any data that is necessary from their enrollment, and ultimately, it’s going to require dedicated time from that study site to ensure that priority, accuracy, and completeness of all of those responsibilities. Next, Seth is going to take us through a visual demonstration once again of how this workload evolves once you have enrolled a study participant.
Seth Halvorson:
Once again, also being in Minnesota, we’ll stick with the Arctic theme and we’ll stick with the snowball. Something that’s often overlooked and what’s thought about what needs to be considered is that you’re actually making more work the entire way through the process. So, what might be thought of as how do we increase enrollment in the beginning? It’s not always appreciated that as you increase your identification and your enrollment, you are continually making and creating more work. And if you’re not looking at managing that entire process and as a collective in a holistic manner, you’re going to run into issues along the way. So here you start off with your snowball and you’re looking at your patient identification, and you go down the path and you get to enrollment. Now snowball got a little bigger. It’s going down the hill tonight. You’ve got more steps. There are more things that you have to do. This is calling. This is your first scheduled visit. Having the communication with the individual, explaining the study, all of those things that we need to do to bring that potentially identified that identified potential individual into that study so that they can be enrolled. Moving along in recruitment in enter into retention. This is where a lot of people think about what study conduct is because they’re thinking about it in terms of the visits. And yes, that is a core aspect of it. You’re covering that in your CTAs. That’s the bulk of what the conversation is. Your study visits, your procedures, etc. There’s a lot of work that goes around that often gets taken for granted and is not thought of. All the engagement with the participant, the things that need to be done to ensure that that participant stays engaged, stays informed, wants to participate, having individuals drop in our lost follow-up or pull up a study after you’ve done all the work of identification and recruitment, you don’t want to let that happen. So you’ve got to make sure that you’re thinking about that and engaging that in the entire process. And as Shelby started off with, you got to remember that that creates a lot of documentation. There’s a lot of paperwork that happens, and that’s good. At the end of the day, that’s what we’re trying to do. We’re trying to go through the process and bring individuals in and collect the data about the study, so that data can be analyzed and hopefully new therapeutics come to market. That’s the goal. It’s a good goal, but along the line, as it works, more work is created, not less work. And so, when a site is thinking about it, the best way to think about all of this from the process is making sure that you look at all of the different parts and how they interact with each other to make sure that you can provide study acceleration overall. Back to you, Shelby.
Shelby Ward:
All right. So jumping off from that, you can see that many of those activities were leading into the next thing. Your snowball kept getting bigger, so it’s important to remember that many of these activities are interconnected and they work with one another in tandem. So before we dig more into the specifics regarding the complexities that a site may face with their recruitment retention. It’s important to recognize that recruitment retention are not mutually exclusive. So recruitment and retention challenges are often not going to be the cause of just one specific barrier. Normally, they could be the interconnection of multiple factors. When you have processes that are working in tandem with one another, a breakdown in one process is inevitably potentially going to cause a challenge with another process, which then impacts another process that’s connected with that. So let’s dive into some of the primary factors that could impact a study site’s operations. The first is study team capacity. So, data is clear. Multitasking is a myth. I know some people think they can do two things at once, but truthfully, to do something well and to do it right, you cannot do two things at once. It requires a dedicated focus, and that’s why it’s critical for sites to have sufficient staff to maintain those critical requirements of their study. This often requires a team also that has very specific skill sets that will align with their associated responsibilities. For example, the skills that you would use to identify and pre-screen patients are different from the skills that you would use in order to enter clinical trial data into an EDC. This the brain the pieces of the brain that you’re using for these skills can vary, so it’s essential that sites have the staff that they need to effectively operate on the study. And the best way they can do this is by having a diverse team of specialized skill sets.
The second piece we cover is site priorities. Recall earlier in our presentation that we shared that over half of respondents are operating on more than 26 studies at any one time. Some of them, many more than that. That means that sites are juggling patient priorities such as study visits, some planned, some not planned, as we know, across an array of studies. Patient care is always going to come first when it comes to prioritizing a site team schedule, so that’s going to be where a lot of the prioritization on a week by week basis and a day by day for the scheduling is going to go, and sometimes that can be unpredictable because inevitably, as F mentioned, we’re dealing with people, and you can’t always predict that.
Thirdly, we have protocol complexity, so protocols have become increasingly more complex over the years, and it’s assumed that by that pattern, they’re going to continue to follow that trend as we learn more about disease demographics, and we strive to ensure that studies provide the utmost highest level of safety and benefit to the patients they’re intended for. However, it also needs to be understood that added requirements will require that sites pivot to scale their operations in order to meet those elevated requirements, and this will they’ll rely on sponsors to be able to provide them with fit-for-purpose solutions that will help them in accelerating and meeting their study goals overall.
Next, we have study technology. Technology is a great thing, right? It definitely has driven us farther, arguably, than any one invention. However, it also can become a burden when it doesn’t provide interconnection, and that’s an issue that’s kind of present in the industry today. We have a surplus of siloed technologies that were built for purpose but without full interconnection. So as a result, sites are faced with an ask to learn a large volume of tech. Again, understanding that many sites are working across a very large portfolio of studies, this means that they could be asked to learn tech across a wide range of studies. And so, it should be understood that sites may also need resources that can provide the dedicated focus that’s needed to ensure that those systems and those technologies are updated accurately and within any time expectations that might be stipulated within a study protocol as well.
Lastly, operational structure as protocols continue to grow in complexity. There also may be cases where your sites may not have items such as a core specialty equipment or perhaps a specific diagnostic procedure, just as a few examples. However, they may be more than qualified in every other sense to operate on a study. So it may also require augmented support that fills those gaps to ensure that your site is able to offer these therapies to their patients. All right, and this is where we come to our next question. So the question is: Can you share thoughts about training and staffing and retention of clinical research personnel, so training is obviously key-a key first step to ensuring that your studies are going to run smoothly. It’s also key to ensuring that you avoid frustration and burnout among your study team. A properly trained study team is better able to set their priorities and to manage complex protocols. The second step that’s important to keep in mind is understanding expectations. It’s imperative that your site advocate for teams by way of keeping an open line of communication with your sponsors and your CRAs. That way, you can understand what is expected of participation in that study, and you’re able to funnel that down to your team so that they’re able to work in line with those expectations, and also keeping those communication lines open allow you to be able to communicate any resource needs that you need to your sponsor and your CRA proactively.
All right. In the last slide, we illustrated many of the precursors that can impact a study site’s feasibility. This slide more so illustrates how the actual requirements of a study protocol itself can impact a site’s enrollment capacities. As we previously noted, the moment that a site enrolls its first patient, there’s going to be a cascade of processes that are initiated, and they must be maintained simultaneously. Enrollment is ultimately the primary goal when a study site first initiates on a study, but it also creates more work for the site that then needs to be maintained for an extended period of time. So, Visay experiences challenges maintaining the retention requirements. As an example, it could inadvertently impact its ability to enroll it to its full capacity. So, thus recapping on our earlier point, it’s important that you see recruitment and retention as interconnected when you are planning your strategies for operationalizing these studies, because these process processes work together in partnership, so a breakdown in any one of those pieces could impact other components as well. And off to set.
Seth Halvorson:
So as Shelby was talking about how they’re interconnected, this slide gives an example of where we would group the various tasks, and by no means is this exhaustive. You can see that this is not. We couldn’t get an exhaustive list on this for all for a host of reasons. But you can see that the participant identification and the enrollment and the retention and data verification, all of the tasks that go along with that comprise the whole overall. In specific to this, we’re going to go in in a second and dive into, and she’ll go into more detail on examples and tactics on the participant identification specifically. But before we do, we wanted to call out another question, which was, do you have any help for advice for participants to navigate barriers associated with poverty, great question. And what’s the best way to go about retention? A related question. We would say taking at that slide before and focusing on these aspects. One thing is critical: is you need retention needs to be thought of at the protocol development stage first and foremost. It needs to be considered there. It needs to be considered throughout the process. In the beginning of the enrollment process, you need to be thinking about retention. Need to be thinking about the impacts. When understanding the patient population and understanding the demographics, it’s important to understand in advance and do the homework to figure out if there might be barriers. Anticipate those barriers and then allow for those and build that into the study plan. Do not introduce whether or not somebody has a car or has means to pay gas as an additional IE criteria inadvertently. Don’t do that by looking at it from the standpoint of coming in and saying this is the demographic that we’re trying to hit or this is the participant profile that we’re trying to hit, and not look into the account what that what the reality of that person underneath it is to figure out what those barriers are.
So some tactics might include increased support in scheduling. Some tactics might include revisit reminders, engagement kits, a host of other activities on the tactical level. But at the core level and understanding it as a whole, it’s critical to understand that these individuals have raised their hand to say, “I want to participate in the study.” They have taken the time and the energy to say, “I want to be part of this.” It is incumbent upon all of us to ensure that they have the means, and we think about that they have the means to attend to participate in each of the visits that that does not have a disruption on their life, and we take that into account. That’s the transaction. We owe that back to them. That’s the part of this that we need to do.
Sandy Smith:
With that, so staying on that same theme, we do have a question that came in for studies involving rare or orphan disease conditions. What typical challenges do you run into during the patient identification phase?
Seth Halvorson:
If it’s if it’s a lot, so if it’s a rare orphan, usually one of the things, and we’ll hit on feasibility in a second. But if it’s if it’s a rare orphan, oftentimes sites are selected based on their knowledge or their pre knowledge of that of those individuals going in. If you’re looking at it from the standpoint where that’s not part, really you’re looking oftentimes depending on the rarity of the condition, as a much broader geographic region that you’re enrolling from, you’re not looking at a five-mile radius. You’re looking at a 500-mile radius. You’re looking at the United States, and so building in that concierge support, especially for travel, hotels, everything else that’s needed, and understanding what the segments might be necessary for time off, etc. that has to be factored in upfront, and it’s a critical aspect of the component. The rarer the condition, the rarer the disease, the broader the geographic range is likely going to be, and that’s something that just has to be thought of. I think Shelby, this is off to you, unless you want me to jump into this one.
Shelby Ward:
It’s off to me. I got it. All right, so we’re going to start moving into some of the examples we alluded to, going through the process of identifying and pre-screening patients for a study. So it all starts at the beginning with feasibility. This is where you’re trying to measure your study site’s contribution by understanding your sources of potential enrollments. In this slide, we’ve identified the difference between kind of the two main categories of potential participants. The first being internal, so these are individuals that may be found within your site or your study site networks database. Oftentimes, or individuals that are known to your site that may be coming in as active patients, sometimes inactive patients as well, but those that have at one point been in your clinic physically.
The second category are external referrals. These are individuals that you may reach out to via kind of external efforts such as media or community networking efforts who raise their hand to want to learn more about the study. There are considerations that you’re going to need to keep in mind for both of these different potential participants when it comes to feasibility and understanding what can be expected from a study site. That is a transactional exchange. The sponsor requests the data. The data is provided by the site. What’s really important to recall, though, is that behind the scenes as a site, this number is a generation of the work that’s being done day in and day out by your care providers. So the number of enrollments defined for your feasibility may be transactional at surface level, but it’s the result of extensive engagement that must be dedicated in order to provide a transformational experience to those patients. So it’s about striking that balance between what is transactional and what is transformational when planning for a study. So now we’re going to define the feasibility formula a bit more specifically.
All right. So feasibility is the summation of your expected enrollment from your patient database. That again would be your internal participants plus your expected enrollment from external sources such as media or community outreach or other efforts. There, like I mentioned, are going to need to be considerations for both participant groups. So, starting with internal review, some things to keep in mind potentially first is your participant identifiable within your patient database based on their medical history as it stands, or in turn, perhaps this is a study that’s framed upon more of what we would consider a moment in time patient. An example could be a GI study where that individual has to be in a specific flare status in order to qualify for the study. So, thus, it is an individual that is within your database, but you expect is going to be in your clinic during some point of the study recruitment phase. It’s more likely for those type of participants that the site team will need to proactively implement a system of flagging, as well as kind of a watch and wait process to ensure that these patient participants are kept informed and engaged, and that their health status is closely monitored, so that if and when they would qualify, we can provide more information to them as soon as possible.
When it comes to external referrals, some considerations to keep in mind. First, what is the motivation for external practitioners to refer these patients? If you’re doing outreach, it is imperative that you develop a strategy that accounts for the type of practitioner that you are connecting with. Just an example from our experience: a general practitioner may be more inclined to refer initially, as oftentimes they need to refer on their patients to specialists anyways for certain diagnoses and treatment. However, a specialist that’s already treating the patient for the disease associated with your study is going to require maybe some additional thought into how to tap into their motivations to partner and refer their patients to the study. Next, do you foresee outreach to be a successful strategy to connect with your intended patient population? If this is a question that you don’t know the answer to, it can be really helpful to reach out to your local community and just start talking to people. Look for resources that would be applicable to the patient population, and really, your goal is to gain insight into the willingness of those potential participants to seek external treatment options. Lastly, it’s important to put yourself in the shoes of that patient as much as possible, which I feel like is easier said than done. But this will help you to be able to identify the most likely opportunities for visibility to your intended patient population.
We also received a question along the lines of this topic as well. The question asks if there’s any information about strategies to recruit patients with low clinical research understanding. With this, I find it’s really important that you need to meet the patients where they are. You need to be able to put in the time to help them to fully understand where they may have gaps in their understanding. So treat recruitment as a process always, and adapt the strategy based on the demographic. In this case, ask the participant questions to gage what their level of understanding is, and then build upon that foundation. Your biggest goal is to build trust with them. I don’t know about you, but for me, when I don’t know something, I often just get on the good old Google and I start finding out as much information as I can, so that I can feel like I’m making an informed choice. And when it comes to someone’s health, you can expect very much so that they are going to want more information versus less. So it can be really helpful to do a thorough walkthrough of them of not just the study, but how does clinical research work in general? And in these cases too, sometimes it’s even helpful to bring in their support system, maybe loved ones that are close to them, because the more comfortable that you can make them feel about their participation, the more likely they are to be able to ask questions and to ultimately potentially move forward with participating in the study as well. So always make sure that you’re putting in the time to meet your patients where they’re at.
On the other side of that, it needs to be understood that sites are going to need to do that work, right? They are going to have cases where patients are going to require extensive time and dedication. At the end of it, it’s worth it to get them enrolled in the study and to be able to offer this medication to them as a treatment option. But it is going to take a lot of time from your study teams. All right, and then we jump into the recruitment process. And while this may seem like a very simplified step-by-step view, as Seth had noted earlier, at its core the pieces can really be kind of funneled down to simplified processes. However, when you’re dealing with people, there are infinite number of variables that can come into play during that process. So, oftentimes, this is not a simplified process for that reason. So, what’s not accounted for in this scenario are some of those site-specific processes that may come into play, complex protocol eligibility requirements, and most certainly not the amount of time that’s going to be required to complete each of these steps thoroughly while maintaining any corresponding documentation requirements that you may have of your study as well. So again, we need to take into account that many sites are working across a very large portfolio of studies and doing these things simultaneously many times over, so the necessity for additional resourcing may arise in at least a few facet of B-side operations. And over to you, Seth
Seth Halvorson:
So jumping into some of the actual tactics, as Shelby alluded to before, EMR system query, one of the one of the first and the easiest ones, assuming there’s an EMR, and I think most cases there are still some paper charts out there in the world, so let’s not take it for granted. But in most cases, we’re looking at an EMR, and it’s a it’s a measure of looking at the ICD-10 codes going in and checking against the IE criteria and seeing what the potential match is. This is often sometimes used for feasibility, and sometimes exclusively, and sometimes as part of what a site’s expected enrollment contribution is going to be from their internal participants, as shall be indicated. So that’s the contribution level from what they might expect from those internal participants. This one, and then this is this one of the easiest and most clean cleanest ways, if that’s the word, I think cleanest is the word, to go ahead and find for the individuals initially. If anybody wants to know if Seth went to the dentist today, the quick answer is yes. So I apologize for that.
All right. So going into chart review, talking about chart review. So chart review is the process. A lot of times, it’s thought of in the EMR context of looking at the EMR for finding and identifying and querying the database. Chart review is the process of looking then at that next level deeper of looking at those individuals and those names that hit the initial query, and then seeing if they’re and doing that further pre-qualification to see if that they are qualified for the study. So that’s going to be looking at the IET criteria, looking at the individuals, looking at the systems, and as Shelby indicated before, there’s an entire site process that’s part of this as well. So we’re talking about the general, and then you get into each of the site and the HCO’s nuances and how that gets managed when you’re doing something like chart review that you need to take into account. The system flagging patients that could be contracted for preliminary eligibility, Flair is a perfect example, as Shelby talked about. You can look and you can see if they have they’re pre eligible, but the whatever condition to that moment in time isn’t relevant today. With proper chart review, you go in, you flag it, and you identify it. Between the EMR review and the chart review, you’re going to get a really good sense of what that internal contribution is. There’s one more level of that chart review that comes in, which is when you’re talking about what we would call the prospective chart review, and these are individuals that might come in in the regular everyday course of their care. So if your clinic is seeing individuals and migraines, an easy example. They haven’t presented with migraine before. They walk in with a migraine, and now they might be eligible. So you look at the retrospective chart review initially, see what’s existing, and then do the prospective continued review throughout the rest of the enrollment window to look at who might then come in that might be qualified.
Question: So, are there tools you would recommend track and assist the CRC’s effort? Yes, absolutely, positively. Get out of Excel. So, there are multiple providers, ourselves are included, have different tools that use that you use for this process. Managing this process, as Shelby said before, technology is good here, this is where technology is good. You want a system that can track and manage end to end from the initial contact all the way through the final disposition. You want to know where they’re at in process. You want to know where they’re at in status, and you want to know what action is expected. There are several systems out there. I’ll plug ours. Ours is very nice, but in addition, they are out there. You do not want to be in Excel as the system going forward, it Excel as a data storage system, it’s ripe with theirs, as we all know. It’s great for crunching numbers, fantastic tool, wonderful tool. Don’t use it as a database. So I would say that yes, there’s lots of centralized tools, and you want to make sure that you’re using one. All
Shelby Ward:
right, thanks. It’s over to me now. So, sticking with the theme of identification of study participants, Seth just went through a bit about identifying someone from your internal database. I’m going to start to jump into a little bit about outreach and identifying someone who is external to your site. So, oftentimes when a site has exhausted its enrollment potential within its database, the next step is going to be to look at our external sources of potential participants. This is where we would look to pursue community network opportunities. We’ll talk a little bit about media as an opportunity as well. One thing to note: a well-executed community outreach plan requires, cannot stress this enough, extensive focus to identify those opportunities, create a tactful plan for your outreach, and sufficient time allocated for follow up. From our experience, outreach is normally not a one and done experience. It takes a lot of time to set up those relationships within your network to build a system of trust, so it requires someone who is able to dedicate the time that’s necessary to really keeping those relationships warm and keeping those other sites engaged, and really tapping into those resources. Again, it’s important that you put yourself in the shoes of the patient to be able to understand where they might be frequenting in the local community. It may not always be a physician’s clinic, right? It could be support groups, local libraries, colleges. You know, just depends on what your patient population is going to be. And lastly, outreach is a transactional metric to the sponsor. It feeds into visibility and how many individuals that you expect that you would be enrolling from external efforts. However, outreach cannot be seen as transactional to the study site. The most successful outreach pathways are those that are the result of long-term relationship building and mutual collaboration. While your community outreach efforts may benefit you greatly on your current study. They also are a great way for you to continue to have a source of enrollment in the future as well. So it’s really important to put a lot of time and dedication into those resources. But it’s also necessary to understand that that time and that dedication is going to be necessary. All right. Next, one of the community outreach pathways that you could be pursuing is referral provider networking. Specifically, this is where you’re connecting with local physicians and healthcare networks for the purposes of establishing a referral pathway for your site, identifying local clinics that may be treating the demographic of patient. Again, you want to formulate your strategy for outreach, and consistency is key. So again, you need someone that is able to put in the time, the dedication for these efforts. Someone once told me back a long time ago, it takes an average of at least seven touches to create a meaningful relationship with someone, and that’s a mixture of in-person, over-the-phone, email correspondence, meaningful correspondence, a minimum of seven touches in order to set up a successful collaboration. Providing the study education to the physician teams and opportunities for them to be involved in the active referral of potential participants seeking those expanded treatment options will be necessary, and fostering connection through continued interaction, as we touched on. One of the questions we received is whether we’re able to provide incentives for referrals for non-prescribing medical professionals, and I’m actually going to take this one over to staff for the response,
Seth Halvorson:
we don’t recommend it. Easy, no. I’m just kidding. It’s the we do not recommend looking at compensation on the results, and the reason for it is you introduce the possibility of undue influence, and you introduce the possibility that there could be a question. You don’t want to introduce that possibility. Paying and compensating for time and materials, time absolutely. You want to, you need to compensate somebody and their provider for their time, 100% But try to avoid, and we we try to avoid having it be a compensation for the actual result, just to avoid any any any appearance that there could be something you know inappropriate with it. So
Sandy Smith
two questions kind of fall into this area. The first is if an individual practice refers a patient outside of their routine provider site. Oftentimes, there’s worries about losing that patient when they’re referring them for a clinical trial. Any suggestions in this regard?
Seth Halvorson:
It’s actually, I would like to think that it’s not. I want to be careful not to put my foot in my mouth on this one because there’s a little bit of a. If the focus is on the clinical trial and on the on the on the trial and the participation, there should not be a concern of losing. I would. I I don’t want to say that if the the relationship was such that that’s not a possibility, there won’t be a new relationship that gets formed. There there is that possibility, but it shouldn’t be the focus. The focus should be on that individual’s care, and the focus should be on getting that individual the best care they can see and they can find. And so my hope is that that concern would not stop somebody from referring, and that they would refer anyway.
Sandy Smith
Great, and are there any special considerations on recruitment and retention for individuals that are in a clinical practice and the trial involves procedures or devices?
Seth Halvorson:
Rephrase that. I think the answer is ask that again. Any special
Sandy Smith
considerations on recruitment and retention for individuals who are placed on clinical trials with a procedure or a device, and that patient is part of a clinical practice?
Seth Halvorson:
Ooh, that’s a good question. I’m yes. The short answer is going to be yes. I would want to refer to our IRB colleagues on this one, and not and answer that one too specifically. The yes, whenever there is a, whenever there’s an individual in the practice who’s participating in the study, you want to be mindful and be careful there. So yes, there are considerations there, and whoever asked that question, follow up with us. We can we can we can dig into that and get specific. All
Shelby Ward:
right. The last outreach effort here that actually we might have one more that we’re going to be connecting on attending and hosting health events in the local community. So oftentimes this is going to look like you know virtual or in-person health events that are going on, wellness clinics, things like that. Doesn’t always have to be health-related, but a lot of times, from the efforts that we’ve seen, that’s the majority of where these efforts are being dedicated. Are those events that are more specific to health-related activities? So this is where you’re identifying public events in the communities surrounding the sites that are appropriate opportunities for promoting and sharing study education. The goal is obviously to connect with potential participants or individuals there that may know of people that are impacted by the demographic for this study and being able to provide them information. Something that’s good to keep in mind is that your sites are going to have to be working through a lot of logistical requirements in order to be able to capitalize on these type of events. So confirming logistical requirements such as attendance, funding, things of that sort, materials for distribution, coordinating their study team, making sure they’ve got a solid strategy. So when they go in there, you know who’s going to be doing what, and then lastly, and probably most importantly, having a plan for follow up. Right, once you get all of that information out there, you connect with people, you hear who’s interested. Once you get back to the study site, the most important piece is making sure that you’re getting back to them quickly. So ensuring that you have your kind of main point of contact identified for that seems easy, but something I think could be overlooked. So good to know. And then grassroots efforts. So we’ve got a slide on media after this, so I’ll just keep this kind of short and brief. When it comes to grassroots, it’s more about just kind of canvassing the local area and providing study education. So looking at local areas of interest for your patient population, things like libraries, community centers, colleges, places where your demographic might be frequenting, and again, you’re going to need someone that you can dedicate as a point because these efforts are going to take a lot of time from the team. They’re worth it in the end to get potential enrollments into the study, but it does take a lot of time. You gotta really be a people person too. Get out there. Don’t take no to heart too too much, you know, and just kind of talk to people and see what they’re thinking. And then, lastly, kind of back on the tracking piece, it’s really good to have some sort of tracking in place, so you’re able to see kind of what you covered as far as your networking strategies and what’s working really well and what’s not working really well. So moving forward, you can really work with as much efficiency as possible by tapping into those outreach efforts that have brought you a lot of success. And Seth, I’ll take it over to you for the media piece.
Seth Halvorson:
And ironically, we are giving in the interest of time. We are going to give probably the least amount of time to what people traditionally think of as what recruitment is, which is external media recruitment. And oftentimes, that when someone thinks about recruitment overall, they’re thinking about just outreach and they’re thinking about the ads. And traditionally, that would include your print, your radio, your TV, and digital today. And the is it’s a fantastic way of increasing the scope and the reach of a site. It works very well for patients who can identify, who can self advocate, who can come into the study, who can understand their condition in such a way that they can respond to an ad. It remains a very effective tactic, and it’s very and it’s and it’s highly useful. It’s one arrow in the quiver, as we talked about before. With everything else that looking at when you’re looking at identification, you’re looking at the recruitment. It’s one tactic, and it’s a good one, and it’s one that should be used, and it’s one that should be considered when your sites have exceeded their internal capacity or their internal contribution. Absolutely, you’re going to need to look at the external sources, or that individual is going to need to walk into that site. So, that said, the we did get one question on this one, which was, what’s the best media? Is what is the best media for advertisement? Is digital the best? It’s the easiest to track. So let’s say that if you’re looking at something that’s the easiest to track, you can get down to the clicks, you can get down to the type of ad. You can get down to the market. You can get very specific as far as which ads run and which ads yield rich result, which you can’t do as well with radio or print because yes, you can tag the the location they go to, but you just have a lot more flexibility with digital. It’s a lot more responsive, and it’s faster. So if you’re running a A B ad campaign, and you’re trying to figure out which one is more successful. You’ve got more ability to pivot and adjust with digital than you do with other sources. But that said, if you’re looking for an ad where maybe someone isn’t online or the patient population isn’t online, well, that’s not going to do you too well. So you’re going to want to go to whatever medium that individual’s is because you need to meet them where they are. So with that, Shelby, I’m going to give you the one-minute closeout. Take it; it’s yours. One minute.
Shelby Ward:
We do have one conclusion slide after this, so I’m going to keep this short and sweet. Thanks everyone for hanging on with us here. An hour goes much faster than I expected it would. So once you have your patient identified, right, the next step before enrolling them into the study is going to be pre-screening, which often can also be a very time-intensive task. It just depends on the patient population and ultimately what that patient’s health status is. They might have a lot of additional questions about their participation, so it’s really your first ability to set the stage with them about the requirement for engagement in the study, what they can expect, helping make sure that you know all of their concerns and their questions are answered. And so, one thing to keep in mind is you know a patient may take five minutes for pre-screening; it may take 20 or more minutes for pre-screening. So it adds up very quickly. Again, the point that sites may need resourcing to make sure that they have enough of that time dedicated to make sure that their patients receive that thorough review that’s needed during pre-screening, we can pop it over to the conclusion slide, which is on you, Seth
Seth Halvorson:
So I will say that in interest of time, don’t underestimate the time that it takes. Similar to how Shelby and I underestimated the time that this webinar would take, so don’t do that mistake. But the it just keeping in the participant front and center in every conversation, making sure that that individual going through that study is the focus, making sure that their experience is the best it can be that is the duty of all of us here. And making sure that that is front and center, a lot of this will resolve itself. Understanding that it takes time, understanding that you need to have engaged participants you need to have, you know, in order to retain the participants. And really, be open and honest in the communication to get to the goal. Keep the goal front and center, keep the goal the priority, keep the goal in the discussion. The goal is to complete the study so that we can get therapeutics to market. That’s the goal. That’s what we are all here for. Do that. And if we do that, We’ll work out all the details, they’ll come up, they will come out, we will make sure that we can get you done
Sandy Smith:
Seth and Shelby, great information shared today. And clearly you both represent a great service offering from WCG on recruitment and retention. I know there was a question for us to maybe describe some of our services. We had a lot of question come in. We will try to respond to all of them after the webinar. But if you are interested in learning more about WCG’s recruitment and retention solutions, just respond to this question and we will be sure to have our team follow-up with you. Last but not least, I would like to remind everyone that this is the first of our three part webinar series. Don’t forget to join us next on November 7th where we will be focusing on study start-up. Thank you for joining, thank you for sharing your questions, and thank you so much for your commitment to science. Have a great day.