Transformation in Trials
A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, roles and change itself is changing. We speak to people in the industry that experience these transformations up close and make sense of how the pressure can become a catalyst for transformation.
Transformation in Trials
Revolutionizing Patient Recruitment in Clinical Trials: Unlocking Access and Accelerating Drug Development with Jill Pellegrino
This episode reveals alarming statistics about patient access to clinical trials, highlighting that only 3% of patients currently have access to participate. Our guest, Jill Pellegrino, CEO of Auto Recruitment, shares innovative strategies to engage the other 90% of the patient population and discusses the importance of digital advertising, pre-screening, and patient support in the recruitment process.
• Discussion on the low percentage of patient access to clinical trials
• Barriers for physicians and research sites in patient enrollment
• Strategies to engage patients through digital advertising
• Importance of pre-screening for trial eligibility
• The role of EMR technology in improving recruitment
• Ensuring patient engagement post-initial interest
• Feedback and response from clinical trial sites
• Future plans for wider patient access to clinical trials
• Emphasis on patient-centric approaches in clinical research
This week, if you have any questions about Auto Recruitment or want to connect with Jill, visit https://www.autorecruitment.com.
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Reach out to Ivanna Rosendal
Join the conversation on our LinkedIn page
Welcome to another episode of Transformation in Trials. I'm your host, ivana Rosendahl. In this podcast, we explore how clinical trials are currently transforming so we can identify trends that can be further accelerated. We want to ensure that no patient has to wait for treatment and we get drugs to them as quickly as possible. Welcome to another episode of Transformation in Trials. In this episode, we're going to focus on end-to-end patient recruitment for clinical trials and to discuss this topic with me in the studio I have Jill Pellegrino, who is the Chief Executive Officer of Auto Recruitment. Hi, jill.
Speaker 2:Hi Ivana. Thank you for having me Looking forward to speaking more about auto recruitment and end-to-end patient recruitment.
Speaker 1:I am very excited to have this conversation with you and Jill. Just to set the stage for our listeners, can you tell us more about how patients are usually recruited for clinical trials?
Speaker 2:Sure. So clinical trials usually the primary route to find patients for clinical trials is through the clinical trial research sites, so sites where doctors' offices or physicians are always hired to facilitate the trial, take care of the patients, collect the data, act as the primary investigators, but then it's also assumed that they would be able to find the patients through their practice. This is what we've seen is actually. This has caused a lot of challenges in clinical trial enrollment for a couple of reasons. One of the primary reasons is that there's not a lot of physicians that actually participate in research.
Speaker 2:I've looked at different stats that demonstrate how many people actually get access to trials through physicians, and I've seen stats as low as only 3% of the population get access and as high as 10%. So there's not a lot that participate and because of that, the sites that do participate are working on a lot of trials. They're competing across many different indications and conditions and sometimes working on studies in the same condition, so they're not as efficient as they could be. But ultimately what ends up happening is that there's a very large portion of the population that never ever gets the opportunity to participate. That's really where AutoCritic focuses on. We focus on developing strategies to access that other 90% and give them the opportunity to participate in trials.
Speaker 1:I would be curious to dig a little bit deeper into this statistic, because it is shocking to me that only 3% of patients actually have access to clinical trials and that so few sites participate. Would you know why it is so few sites that are repeatedly enrolled in clinical trials and why there's such a big number of sites not currently active?
Speaker 2:Yeah, there's a couple reasons I attribute to it, I do think it's a pretty significant barrier to entry for physicians to enter into clinical trials. A lot of times when pharmaceutical sponsors are developing new treatments and writing out the protocol, they're very much interested in looking for sites that have experience in this protocol, trying to increase the chances of that data is going to be high quality and that you know that the study will run successfully. So it is a little bit hard if they don't have any experience and on top of that there's a lot of resources and capabilities that they need to bring into the sites and to be able to enter into clinical research. So it isn't an easy entry for clinical practices to start research. But on top of that, even within their own population that they have access to, they're not as efficient or have the right expertise or skills to even access all the patients that they do have in their database.
Speaker 1:Oh, that is a very interesting point that even though they may have the patients, they may not necessarily understand that they have access to them. Do we know why that might be?
Speaker 2:I think it's about well one. There is a special skill set that is required to engage a patient and sell them on the opportunity of clinical research. For most of them, that's very different and new and they don't know much about it and you may not have the staff and the site that is focused on that, when they're really trained and skilled at treating patients and understanding medically what a patient needs. So that's one aspect of it, but the other aspect of it is that it's important to capture the patients that are actively looking for new treatment and that are more motivated to participate in trials. This is where auto-recruitment has really seen a lot of success in developing strategies to engage that 90%. When we are reaching out to that population, which we primarily do through digital advertising, we find that the patients that are engaging with us looking for clinical trials, they're very, very motivated because they're out there searching and hunting and they're very open to trying something different or looking for new treatments.
Speaker 1:Can you tell me more about how you engage those 90%?
Speaker 2:Yeah, yeah. So, as I said, you know, our primary strategy and starting point is relying on digital advertising, and our group has been around for 10 years. We're the experts at utilizing digital advertising for clinical trials. We do that across many different spectrums, so social media, search, direct outreach, etc. So we start really broad and we develop our creative and our advertisements in a way that we know from experience speaks well to the patients and the population and helps them understand what clinical trials are as an option. We've been successful in reaching a very large audience. In doing that, we've had about 247 million people who've engaged with auto-recruitment at some point in time, interested in trial.
Speaker 2:But that's just. That's the first step, because you can't. You know, getting a large audience is step one, but then you have to make sure that they're highly qualified for the protocol, and this is one of the areas where I think a lot of other patient recruitment companies may not succeed as well. So we've learned over time that it's really, really critical to have multiple stages to evaluate the patients and prescreen them. So we start with an online prescreener which patients will self-report to us symptoms that they're having, medical history, et cetera. That data is really, really helpful for us to help us optimize our efforts into a form or targeting upfront, but it's self-reported, so for more complex disease states it's not always sufficient. So if it's a more complex protocol, we can follow up with a phone call with our end staff or some of our medical trained staff at auto recruitment If it requires a further you know, deep dive and medical expertise to evaluate.
Speaker 2:And then the third step that we have, which is one of our newest product offerings we're pretty excited about, is EMR capturinguring Intelligence, and what it allows us to do is the patients. When they respond to us, they can opt in to provide permission to get their medical records and it's very seamless and easy for them. Where our technology captures their medical records from many different medical systems in the US uses AI-powered technology to organize that and summarize it so that when we send the patients to the clinical trial site, they're able to search it and see all the medical history right there, right then and there. And that's when we hand them over to the sites. And then we work with the sites and the patients just to facilitate those last steps, to make sure that the patients stay engaged and make it into the trial to participate.
Speaker 1:I would be curious what sort of response have you been seeing from patients who are actively looking for a trial and then actually get the opportunity to engage with the potential of participating in a clinical trial through your ads. Are they interested in this? Is it still a scary thing to be a part of? What sort of response are you seeing?
Speaker 2:Yeah, I think the interest is absolutely high and I don't know if scary is the right descriptor, but they're definitely they're eager for information. You know they're not just going to like blindly jump in and do it. So we do see a lot of interest and I think also after the pandemic, people have a lot more awareness of trials as an option. But what we do find is that we do need to provide an extra level of like customer service, if you will, to keep them engaged and get them to that last mile. So you know, as I talked about, after we pre-screen the patients, we then refer them into the clinical trial sites and but we find that not every clinical trial site will follow up on all of those patients. If they're very, very busy doing all the trials, just depending on what they're dealing with, they don't always have the ability to follow up very fast.
Speaker 2:So one of the things we've added and we've learned that's really been needed is we have an engagement services team that and they're split into two. We have a group that works with the sites and a group that works with the patients, and they're the group that works with the patients, like they're really there to help the patients, help them understand when they should expect to hear from the sites, help them schedule them directly if the sites want them to do that. And then also to answer all the questions, you know any questions they have about the logistics of the trial or the actual study itself logistics of the trial or the actual study itself and we found that having that extra service has been really critical in keeping that population engaged in participating in a clinical trial opportunity.
Speaker 1:That makes sense. Can you tell me more about what does it actually take to get a patient successfully enrolled in a trial at the trial site, because it seems like you're great at getting them to that stage. What does good look like for actually getting them into the trial?
Speaker 2:Yeah, I mean once we hand them over to the sites they have to bring them into the office or, if it's a virtual trial, you know, set up a virtual appointment, but there's some interaction with the site staff. That first starts and usually the site staff will need to review the patient's medical history just to make sure that they're qualified. So all that pre-work we do to pre-qualify, I think is really really helpful in that initial handover step because it's a lot less work for the sites. They can see right with the information we hand to them, that most of the pre-qualification has been done. But they're going to have to do the final review and then they'll take the patient through the informed consent. They'll take them through more of the trial. Hopefully at this point we've given them enough information where they're very interested.
Speaker 2:But the sites will take them through the actual informed consent document so that they have a full appreciation and understanding of the study. And then they'll enter screening document so that they have a full appreciation and understanding of the study. And then they'll enter screening and at that point they're going to have to go through further testing to see if they finally qualify and randomize into the trial. So if it's a study where there may be like a lot of testing that they're going to have to go through. We make sure that we set those expectations up front with the patients, because we're always, you know, we don't want them to be disappointed if I finally make it to a clinical trial site and then they don't enter. So we make sure we're really setting the expectations up front so it's a positive experience for both the patients and the sites.
Speaker 1:That makes sense. What about the clinical trial sites? How have they reacted to having patients come in through you guys?
Speaker 2:Yeah. So I think there's a lot of patient recruitment companies in this space and unfortunately, I think, a lot of time patient recruitment companies get a bad rap because everybody has stories where they worked with recruitment companies and all they ended up getting is a bunch of referred patients that didn't really qualify for the study. And a lot of sites will probably tell you that story where they've worked with advertising companies and the advertising company or the recruitment company didn't really appreciate the complexity and all the steps that's really needed to get a patient into a trial. So you know we take that into serious consideration when we're developing our strategies and we have a really good relationship with the sites that we work with. And we hear a lot that the sites like working with auto recruitment because the patients that we send are very, very qualified, and so I know, I know I actually used to run a site network.
Speaker 2:So before I was at auto recruitment many years ago I was there with B&AS, which is 108 global sites. So I know firsthand what it's like to be the site staff and have to deal with all of the extra work that's needed for outside patients. So I think it's really critical that you take off as much of that, burden off the sites as much as possible, and then they see it as a really value add and a positive experience working with a recruitment company.
Speaker 1:That makes sense. What sort of profiles would help sort through the patients that you can reach with advertising at auto recruitment? Are they medically trained? Or how do you ensure that it's easy to understand whether there's a good fit or not? Yeah well, it depends on the complexity of the protocol and what's required. Or how do you ensure that it's easy to understand whether there's a good fit or not.
Speaker 2:Yeah Well, it depends on the complexity of the protocol and what's required. They absolutely have to have expertise on the protocol itself and have a really good understanding of that criteria and the types of patients that are going to be qualified for it. And I think the most skilled people that understand it the best are the ones that could kind of read between the lines of the protocol, like there will be criteria that says you know they have to have, for example, moderate to severe disease, but they know from experience, or they know with working with this patient population, what are the leading questions or the kind of roundabout questions to help you understand if it's really moderate to severe and so that's you know it's definitely the medical expertise, but it's also that expertise of the you know the human medical literacy and like, how do you interpret that medical criteria in a way that everyday consumers and patients can understand and clearly communicate what they've been experiencing?
Speaker 1:That makes sense. I'm also thinking about this aspect of getting the remaining 90% of the population into the clinical trials. What would this mean for our clinical trials if we actually had access to that broader patient population?
Speaker 2:Yeah, I mean we we've been. So we've been in business for 10 years and we've worked over 120 conditions and across those conditions we've randomized 13,700 patients. So we know that some of the strategies that we're deploying work very effectively and for the studies that we have worked on and it's very common for us to be contributing 50 to 75 percent of the the patients for that trial and on average that's resulted in about nine months of time savings. And so if you deploy a strategy like that more broadly across the clinical trials, the impact could be pretty significant. Clinical trial delays is a well-known common problem that the industry faces and 80% of clinical trials are delayed because of enrollment challenges. And 80% of clinical trials are delayed because of enrollment challenges and 55% of drugs never actually finish the clinical trial process because of enrollment challenges. So you know, applying a process like this can be pretty. It can be very impactful in really meaningfully allowing the industry to get new treatments to patients faster allowing the industry to get new treatments to patients faster.
Speaker 1:That is a huge benefit, and just the time savings alone, but also the time we could shorten the development process and actually get the drug to patients sooner is just mind-boggling. Also, I am interested in the fact that you are tapping into some of the data that is available in the electronic health records and using that to help understand which patients qualify for clinical trials available in the health records and thinking beyond the clinical trials when pharmaceutical companies look for real-world evidence or any data that may not strictly be a clinical trial.
Speaker 2:Yeah, I think there absolutely is the possibility for that. I think the limitations on the accessibility of medical data is a challenge. It's a challenge for science and that exists in clinical trials, but it also exists in the real world trials where they would be looking at drugs that are already on the market. And, you know, one of the obvious limitations of that is most medical data is protected by HIPAA and it's held by private institutions, and so it's very, very hard for researchers, scientists and even companies that are investing in new solutions and treatments to get access to enough of that data across the spectrum to really inform the science spectrum, to really inform the science. And I've seen, you know, before I was at AutoCrew and I was at CVS Health and I was running their real world evidence business. So I learned a lot about what medical data is available and what are the gaps and the needs there.
Speaker 2:And the industry really focuses a lot on utilizing tokenization, which is a way to take data sets from different sources in a de-identified way and put them together, and it's really the only, you know, the best solution that's out there, because it's not, there's not really any way that they can get access to it, except if you do it through the patient.
Speaker 2:So the patient is the only one that has the power to give the approval to get access to all of those data points.
Speaker 2:But on top of that, not only do they have the power to give approval to all their data points, but they also have the ability to give you all the non-medical qualitative data, like the behavioral data, the things that are driving them to make decisions or limiting them from getting access to different treatments. So I feel really strongly that you'd really really move science forward, whether it's a new drug or you're looking at real world evidence. One of the primary ways to do that is put the patient at the center of the research, and when you do that, then you just get all the data. And our experience at Auto Recruitment in AutoCrew in taking a meaningful stepping stone in that direction with our EMR solution. It's demonstrated improvement that patients are willing to raise their hand and do this. Other patients offer the EMR option to. About 90% have said yes, yeah, we have no problem giving consent for the purposes of a clinical trial now that that makes a lot of sense.
Speaker 1:Um, that is a powerful perspective that I would be very curious to see unfold, and having the patient at the center, bridging those two very different worlds, yeah, but I'm also assuming that, for the patients, as they learn about clinical trials, having the support from someone like your team, helping them understand what their options are and how to qualify for a trial, must be extremely helpful.
Speaker 2:Yeah, absolutely, Because I think the awareness is there. They know about trials and research, but that's about it. You know they have a lot more questions about what are all the other benefits and most patients, once you educate them on it, are very willing to participate and very eager and excited about participating.
Speaker 1:And who would your typical customer be? Would it be the sponsor, the CRO, the sites?
Speaker 2:Yeah, it could be all of the above and you know, I think our primary customers are the pharma and the CRO, but we, you know we'll work with sites as well. I think all three of those parties are eager and interested in finding ways to find more patients.
Speaker 1:How could we get more sites in general engaged? Would that come from having interested patients that may approach their own HCPs, or how could we expand the amount of those?
Speaker 2:Yeah, I think sites. Like I said, I think one of the reasons why more sites or more physicians don't enter into research is it's a pretty high barrier to entry and the more services that are provided for them to make that easier, the more willing they're going to do it. Like there's a lot of companies out there that will put in clinical research services into what they call research naive sites, and that's definitely a motivator. So I think having access to patients and patient recruitment solutions would also be a motivator, because it's one less thing that they need to worry about and then they can focus on what they do best, which is treating the patients or receiving the protocol.
Speaker 1:That makes sense. Well, Jo, you obviously have some expert knowledge in this space. I would be curious to learn more about which journey did your career take to get you to where you are today.
Speaker 2:Yeah, sure, I have been in this space for about 17 years, which often surprises me that I'm still in patient recruitment. But my background is actually in mathematics. I started in the mortgage industry. I just love doing math. I wanted to figure out ways to apply math and I got a job at a company called Curian, which is a patient recruitment company, for 14 years.
Speaker 2:I just was really loved, the company, really interested in this clinical space and how it combined the elements of marketing but also the clinical.
Speaker 2:So I stayed there for 14 years and then that was bought by E-Zero and then they merged a carry-in with a bunch of site networks which became GATS. So I was on that leadership team and then overhauled the site network and then I left there in 2021 to go to CVS Health and at CVS Health I ran their patient recruitment business as well as their real world evidence business and then I left there at the end of last year to come join auto recruitment. So I've always I've been in different companies that always have really been focused on the patient recruitment aspect and I've seen it through different lenses. You know I've seen it through the site lens and through digital marketing lens. Also saw it from like the CVS health lens, like how does it ultimately impact how drugs get to the market and our price? And I think throughout that whole journey you know my passion for really focusing my career on finding solutions for clinical trial enrollment has only increased.
Speaker 1:And it's amazing how many of us who are in life sciences we started out somewhere completely different and maybe like randomly stumbled into the space and and just never left exactly yeah, I feel. I feel blessed, though I really enjoyed working in this space no, I, I absolutely yeah, if you look a little bit ahead for auto recruitment, what are some of the next challenges that you're that you're tackling, or what are some of the things that you're excited for in the in the coming years?
Speaker 2:yeah, yeah, um, when I, when I first joined auto recruitment um, you know, I, as I mentioned, the business has been around for 10 years it was a founder-run business and where the founders left last year and I was so impressed by what they were able to do in this space, having been been in patient recruitment for so many years when I saw the success that auto recruitment has had, I was really impressed and that really came down to the people, the team here, their expertise, the use of technology and the digital advertising expertise. It really allowed them to be successful. But there are so many other conditions and customers that this company has not worked with.
Speaker 2:So one of our primary focuses and our near-term focuses is how do we continue to demonstrate that value in clinical trials and find access to patients, but do it broader, across multiple conditions, because every therapeutic area that you move into has some challenges, you know, has, you know, has the new things, and that's really what um was the precedent for the development of the emr solution. You know we really want to apply what we've done successfully and put that into a much more complex condition, and so we're continuing to invest in our strategy for doing that. And then we also think a lot about what are all the other areas that we can bring value. We know that the biggest value that we have is that our ability to interact with patients, to access a very large population and to connect them to health care opportunities. And you know that doesn't just apply to clinical trials. There's many other areas in the health industry where that direct access to patients, that direct access to patient data, could be really, really valuable.
Speaker 1:That makes sense. Super exciting. I'll be keen to follow your progress. Thank you, and Jill. As we start rounding off, we always ask our guests the same question towards the end, and that is if we gave you the Transformation Trials magic wand and this magic wand can transform one thing in our industry what would you wish to change?
Speaker 2:Yeah, I love the idea of getting a magic wand.
Speaker 2:I think that you know, being in patient recruitment and having seen the ability to substantially change the way that trials are run, being able to significantly decrease timelines and increase the enrollment rates I know that there's a lot of power in that patient at the center and planning around that.
Speaker 2:I know that there's a lot of power in that patient at the center and planning around that. And one of the limitations that I constantly come across is that when pharmaceutical companies are putting together their plan for a clinical trial, they're thinking about the patient's life. They're always focusing on how many sites do we need to go to, and that's where most of the planning is around and also where most of the budget goes. So I'm really enthusiastic and excited that I think the industry has been making progress and utilizing patient recruitment and utilizing digital advertising methods for patient recruitment is becoming more commonplace. But I think there is a lot more progress to go where patient recruitment is really just an afterthought that's added on at the end. If it was really brought up to the forefront and you designed the whole trial around the patients, you designed the whole trial and the strategies around that 90% I think that can be really powerful and can substantially change the timelines and the landscape for clinical trials.
Speaker 1:I hope that that wish is granted. That will make a big change, for sure. Yeah, yeah. Well, jill, if our listeners have questions about you or auto-recruitment, where can they find more information? Yeah, how can they reach find more information? Yeah, how can they reach out to you?
Speaker 2:Yeah, I'm on LinkedIn as well as the auto recruitment team, but auto recruitmentcom you can go directly there and you can submit a request and we'll get back to you.
Speaker 1:That sounds awesome. Well, thank you so much for joining me for this conversation. This was very interesting and I hope that you succeed in all of your endeavors.
Speaker 2:Thank you so much, Bona.
Speaker 1:You're listening to Transformation in Trials. If you have a suggestion for a guest for our show, reach out to Sam Parnell or Ivana Rosendahl on LinkedIn. You can find more episodes on Apple Podcasts, spotify, google Podcasts or in any other player. Remember to subscribe and get the episodes hot off the editor.
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