Breaking Down Enrollment Barriers: How DE&I, Technology, and Protocol Design Impact Enrollment Success

About this episode:

In episode two of WCG Talks Trials, we are joined by two WCG experts to discuss overcoming common enrollment challenges and how DE&I, technology, and protocol design factor into enrollment success.

Listen in as we delve into the critical topic of common enrollment barriers in clinical trials, how to improve enrollment by focusing on DE&I efforts, the importance of site-centric and patient-centric technologies, and how thoughtful protocol design plays a significant role in enrollment success.

Speakers:

• Jamie Harper, MHA, CCRP – Vice President, Site Solutions & Engagement at WCG
• Tyler Bye – Director, Site Solutions & Product Strategy at WCG

Episode Transcript

Dawn Sauro:

Hi everyone. I’m Dawn Sauro and I’m thrilled to be your host for today’s episode on the topic of overcoming common enrollment challenges in clinical trials. Before we dive in, let me remind you to subscribe to our podcast and follow us on your favorite listening platforms like Apple Podcasts and Spotify, so you never miss an episode of WCG Talks Trials.

We are joined today by two WCG experts, Jamie Harper and Tyler Bye. Thank you both so much for joining us today. Before we get started on today’s interesting topic, we would like to start all of our podcasts off by getting to know our guests a little bit more. My question for both of you today is, how and why did you come to join the clinical research industry? Let’s start first with Jamie.

Jamie Harper:

Hi. Thanks Dawn. Thanks for having me here today. My story really begins in the lab as a clinical laboratory scientist and in the laboratory I was really focused on the hematology department working very closely with our St. Jude Clinic and Children’s Hospital. So being on the diagnostic side of leukemia and other blood disorders, made me really think, how can I help them feel better? How can I prevent some of these things from happening?

And that led me down the clinical research world where I became a clinical research coordinator for our local oncology practice. And at that private community oncology practice, I worked my way up to the director of clinical research where I was there for about 13 years. So bringing that site experience, WCG has been very helpful. And my pathway was really convoluted. It wasn’t a direct lab to clinical research path, but it really did begin in that laboratory space.

Dawn Sauro:

Thanks, Jamie. Impressive experience. Now over to Tyler.

Tyler Bye:

Thanks Dawn. And I echo Jamie sentiment. Thank you for having us here today. So my background really in clinical research, it’s all I’ve ever known on the professional side. Going into school and into college, I was one of the many people who go in knowing they want to go into the healthcare field, but not really knowing where.

I took the pre-med track, did all of the bio and all the chem courses, realized that being in practice wasn’t what I wanted to do. But had the great opportunity right after graduating of becoming a clinical research coordinator at the University of Wisconsin Madison Cancer Center. Being there part of the radiation oncology team, running trials, working with patients day in and day out, and really getting to learn about an industry that it’s the biggest small industry out there.

And I’ve been able to grow in the industry, grow my career, working both on the site and then on the sponsor side. And now here with WCG for coming up on 10 years, I’ve been sitting in this really unique position working with all sorts of clinical research, all sorts of sponsors, all sorts of indications, and really understanding how we can help accelerate the efforts of recruitment and ultimately getting therapies to patients faster.

Dawn Sauro:

That’s great. Awesome experience as well. And really interesting to hear you both have interest and passion in oncology, which is an area that interests me a lot as well.

So now we can dive into our topic for today’s episode, overcoming common enrollment challenges in clinical trials. Can you discuss the main obstacles organizations find and hard to enroll studies?

Tyler Bye:

I’ll jump in on this one. So I think we’re in the unique position. Jamie and I both get to speak with sponsors and sites all day out every day to understand what they’re going through and understanding that enrollment. Well, it seems simple to have somebody join a study. There’s a lot that goes into it. There’s a lot of work that happens.

And I think one of the pieces where we see this day in and day out is competing studies, competing trials that are out there. We know that there are a lot of different organizations, there are a lot of different interests and a lot of different reasons why certain indications have a lot of different studies that are competing. We know that a patient is being offered multiple studies, but they have to choose one. And what we commonly hear from sponsors is that why is it their study not being chosen? Why is their study not enrolling that patient? Why are they potentially looking at another one?

And as we hear about that, there’s a multitude of reasons why, but it really comes down to understanding how do you overcome those pieces as well. I know we’re going to talk about a lot of that. But I think the idea that the clinical trial landscape is always growing. That piece of itself is definitely a challenge for a lot of the industry.

Jamie Harper:

And I think it’s a common misconception that one study site is just doing one trial and that indication, and that’s just not the case. And it often comes down to a question of, if you have multiple studies in the same indication or the same area, the question becomes, do I choose a study that’s easy to conduct but doesn’t pay as much, or do I go with the sponsored study that is a little bit more difficult and more time-consuming, but they pay more? So what’s the priority? Is it the bandwidth and the time and the patient need or is it the financial need in order to keep the doors open at the institution?

So I think that’s a very common push and pull that we see at the sites. And I also think with that, the recruitment plan is very important. And one of the issues that I saw from my site was, at the feasibility portion we would have a recruitment plan in place in order to really determine if we can even conduct this study or not. But then the SIV and site activation may take 6, 7, 8 months, and by that time, the recruitment plan is now out of date.

And the time that had been allocated to do the recruitment plan in the first place is now taken up by other studies that are coming through. So being able to reinvest that time that was spent in the recruitment plan in the first place is no longer available. So that study tends to get pushed to the side. So those recruitment plan development to activation, that timeline is very important.

Dawn Sauro:

I know one of the things people talk a lot about is referrals. And you touched on something that triggered this in my mind, Jamie, is that a lot of the times physicians don’t want to lose the patients from their practice for them to be referred out to a research program at another facility. So how would you suggest that folks overcome that challenge and make sure that the patients that could benefit from the trials are perhaps referred away, but maybe that practice still is able to stay involved?

Jamie Harper:

I think part of the reason for that is lack of information. The physician who’s referring needs the information of what the study entails and reassurance that the participant will come to that research site for the research conducted visits. They’re not usurping that patient over into their patient population.

So I think giving the information about what the clinical trial really entails and really developing those relationships and partnerships and collaborations to build that trust between the physicians is important as well.

Tyler Bye:

And if I can add onto that, I think something, when you talk about referral physician networking, it’s one thing to present the study to another physician or another doctor and say, “Hey, there’s this study available.” But that oftentimes can be forgotten. That can be forgotten in just the daily commotion of patient care.

So in some cases it does take the investigator site or that coordinator multiple times, multiple attempts to, Jamie, as she said, build that trust, build that relationship. It’s an ongoing effort. It’s not just a one time, we’re going to make you aware of this. It is an ongoing check and it’s building that relationship because I mean, that’s really what networking is at the end of the day.

Dawn Sauro:

So shifting gears a little bit and thinking about recruiting and diverse populations, and it’s along the same lines of what we’re looking for because sponsors are looking for more diverse populations, so that’s driving them to put the pressure on the sites to find that. What do you think some of the best practices are for recruiting those diverse populations that our sponsors are looking for?

Tyler Bye:

So this is a great topic in the industry. There’s a few really key areas I think that we can think about for diverse population recruiting or reaching an underserved population. I would break it down to three main areas. So you have the protocol development, you have the site selection, and then you also have just the recruitment outreach efforts and how you’re actually reaching that audience.

I think you really have to look at each of those individually to understand, they all build off of each other, but when you need to bring research to the real world population, starting with the protocol development and how it’s written to identify and recruit individuals, is a key piece. We all know that in clinical research, the protocol defines who we can recruit, who we can bring into the study.

So if the study doesn’t have parameters around it of saying we need to represent a real world population, right there you’re already presented with a new challenge just from the protocol development.

Jamie Harper:

I agree that protocol development is critically important, and having voices that represent the community as part of that protocol development is going to be key. Every population is different. They have different recruitment pathways, they have different levels of trust within the community, so it’s not a one size fits all. So having that participant voice, having that community voice from the very beginning will help mitigate and prevent any issues in recruitment down the line.

Tyler Bye:

Yeah. And as we’re thinking then about the trust piece, I’ll call on a phrase that Steve Smith, the WCG says, “The trust bears in the community.” This is a huge issue I think in research where there needs to be new investigators. We know that the investigator pool is small and there’s always new ones coming into research, but they need to have that connection with their community.

And if we can have a trust bear become an investigator and start that clinical research process with that population already around them, that’s definitely a way that we can increase the ability to bring research to the populations that really need it.

Dawn Sauro:

Great. We’ve recently done a number of site surveys and gathered feedback at WCG, and some of the biggest pain points that we’ve heard from the sites are about staffing challenges, which I think is something that we’ve been talking about for a number of years now since the pandemic started, and also the increasing level of complexity that’s brought to the sites with all the various technologies. I think we’re all trying to help sites with technology, but we’re hearing from the sites that technology and it is sometimes becoming a challenge for them because everybody does it a little bit different. So wondering your thoughts on those two topics.

Jamie Harper:

I know what the shrinking number of investigators and the increasing number of clinical trials, staffing and bandwidth is a consistent topic. And I think one of the things that I think we need to understand is that clinical research is time-consuming. And what I think some sponsors may not realize is that there’s a lot that happens. The in-between study visits, they’re not points in time. It is a continuous process. It is a continuous pathway in order to have that participant from recruitment identification all the way through to study completion.

So it’s these little nuances that each site may have in order to continue that pull through from the patient that may not get recognized in the study budget or just in the complexity of what a trial entails at the site. And that really does contribute to the staffing issues at sites or those little nuanced in-between visits, time-consuming tests that are required.

In technology I think we can… It’s really twofold. It’s technology for the research site in being able to navigate all the different technologies and portals and systems that are used for each individual clinical trial. But then also on the patient side, the patients also have to deal with that as well, and looking at smart technology and smartphones and are they even able to have internet access? Do they have the high speed internet that’s required to run this device? Are they knowledgeable about the technology? So it really is twofold on the research site and the participants involved in those clinical trials that require that high technology. And with high technology also comes high touch for those reasons.

Tyler Bye:

Yeah. I live in the product world, so the technology piece there is really true to my heart and what we’re doing. I think we live in an evolving industry. I mean, this is what clinical research has done over the years. That’s the goal is to evolve and change. With that has come a lot of new tech. A lot of new players in the industry.

One of the things I think that makes things more complex is sometimes it feels like it’s tech for the sake of tech. That doesn’t really solve problems. At the end of the day, I like to try to bring everything and research back to the whole keep it simple process. We are identifying someone, we’re bringing them to the study. We need to get them treated. We need to collect the information.

If the technologies at the site and for the patient aren’t actually meeting those goals, then we’ve overlooked some of the key pieces that actually are needed for research to continue. But yeah, as Jamie said, with technology, it’s a high touch area. Because you think of the concept of an e-diary of somebody filling out questionnaires during the course of enrollment and through the study. If you miss one of those, you might miss that notification on your phone or on your device. It may take a phone call from that coordinator to help you follow up with that. And that’s where I think with technology, there still needs to be that human element, that piece that actually brings everything back together together.

And as you’re thinking about the technology that’s going on, it needs to embolden the relationship between the site and the patient, because that patient and the site, it’s a reciprocal relationship where they’re both putting time and effort into this. It needs to be well understood on both parties, what their obligations are, what they need to do, and what really is defined as success for participation in the study.

Dawn Sauro:

Yeah. I think with the tech topic, we definitely skirted the issue of patient centricity a little bit too. So maybe we can just dive into that a little bit more. It’s a common news buzzword in the industry, but we talk on the tech piece of it but, what other advice would you give to sponsors to run better trials and to design better protocols that are more patient friendly, let’s say?

Jamie Harper:

I think Tyler really hit on it in a previous question on that protocol development and using a patient advisory board for those protocols. Not only will that contribute to the patient voice, the community voice, it will help the protocol be more friendly for those who are willing to participate in a clinical trial.

But I also think we need to think about the difficulty on the physicians, and they have the same stress as the research site and the patients do. So I think it is twofold, again, where we need to focus on the patients, make sure it’s easy for the patients. We’re not adding a new burden by high tech, high visits. Things that may not be necessary. And also the physician as well, and trying to meet all of these stringent FDA requirements, the regulations and everything they have to go through in order to get the patient enrolled. So how do we make it easy for both parties to conduct clinical trials?

Tyler Bye:

If I can add on that, just being patient focused and participant focused, I think one of the key things that needs to happen, and it goes back to protocol design, it goes back to really the site interaction with a participant. Joining a study is a choice. I mean, that is a very much a choice on the participant and oftentimes on their family for them to join that study versus other healthcare options.

The study itself, that is an offer that’s being presented to the subject. It needs to align with their motivations. And I think keeping that in mind of what is that subject’s motivation for joining that study, for being part of that study, for staying in through the duration of that study, that needs to be kept top of mind at the site and even at the sponsor side through the protocol development and execution. If we’re not keeping in mind why that subject has joined the study, you lose sight of really what it means to have that individual and their family being part of that healthcare journey in clinical research.

Dawn Sauro:

Well, I think we’ll wrap it up here. Thank you so much to Jamie and Tyler 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 that you’ll join us for future episodes of WCG Talks Trials. Bye for now.