About this Podcast:
Despite advances in science and technology, we still see that 80% of clinical trials are running behind on their enrollment timeline.
Mark Summers, Founder of WCG ThreeWire, and President of Patient Engagement at WCG, shares his insights on the current industry model of patient recruitment and the philosophy behind the new patient recruitment paradigm.
Things You Will Learn:
- Shortcomings of the current industry model of patient recruitment
- How to better plan for and deploy patient recruitment strategies
- How to find the most reliable and resource effective patients
- The economic philosophy of planning and deploying a patient recruitment program
Cameron McClusky: Hello. My name is Cameron McClusky, and I'm a Marketing Associate for WCG. I'd like to first welcome all of our listeners and thank you all for taking some time out of your busy schedules for our Flipping The Funnel and Patient Recruitment podcast. Today I'm joined by my colleague Mark Summers, WCG's President of Patient Engagement and Founder of WCG ThreeWire. Mark, if you would, tell us a bit about your background and your role here at WCG.
Mark Summers: Good afternoon, Cameron. It's great to join you on this. I've been in the industry for over 35 years. I started my career at an academic site, and then went from there to the sponsor side of the industry. I got involved as an entrepreneur and starting a couple of businesses on the sponsor side, and as a result from my experience there came away with the distinct feeling that there had to be an easier way to get patients enrolled in clinical studies.
After selling the last sponsor company, I started WCG ThreeWire with the goal of tackling a new way to solve the patient recruitment challenge.
Cameron McClusky: Thanks so much, and again thanks so much for taking some time to sit down with me today. Let's jump right in and talk about patient recruitment, or in this case, rethinking patient recruitment.
In doing just a little bit of research, it's easy to find some alarming statistics when it comes to clinical trials. 80% of clinical trials are behind on enrollment, and as high as 68% of sites fail to meet their enrollment targets. I think this really sheds light on the industry wide strategical shortcomings when it comes to patient recruitment for a clinical trial.
Q1: Could you talk about what the traditional patient recruitment model is, what it looks like, and what you think the weaknesses of that model are?
Mark Summers: Yeah, the patient recruitment industry has really evolved around finding patients for clinical research studies. At the root of slow enrollment today are two main causes. There could be many different individual reasons specific to study protocols, and locations of sites, and patient population, therapeutic area, and so on. Most of those can be tied back to one of, or both of, two root causes.
One is that there simply aren't enough patient candidates that are accessible to the sites because out of a population of patients that meet the disease specific criteria for the study, and when I say disease specific I don't mean the I.E. criteria, I mean patients who are in the therapeutic population number one, and number two they know about a specific study, so they have awareness of it, and then number three they're offered the opportunity to participate in that study. A very small percentage are going to end up enrolling. It's single digits. Typically, one to three or four percent.
So that means if we assume, for example, that it's 2%, that's one in fifty. If a sponsor's goal is for a site to enroll five patients, that means that site has to identify 250 patients that meet that criteria, and this is historically where the patient recruitment industry, as it's grown up as a separate industry, has really focused. They focused on identifying patient candidates through various means, typically what has been at the center of it is various forms of direct response outreach using various media channels. A few years ago, it was more traditional media, radio and TV and newspaper, and those are still used, but more recently it has migrated to electronic digital media, social media platforms, and mediums such as that. The industry has grown up around focusing on identifying patient candidates. In fact, many of the longer-term patient recruitment companies in the industry today actually evolved out of advertising agency models.
If you only focus on solving that problem, you actually exacerbate the second root cause of slow enrollment which is limited site bandwidth. Sites simply don't have the resources and the time to focus optimally on a given clinical research study. Investigators typically have a busy clinical practice, they have other studies, they have to spread the resources over multiple studies in order for the economics of clinical research to made sense at their site.
On the one hand, so you have these two root causes. Not enough patients on the one hand, and on the other hand a shortage of site bandwidth and resources, and focusing on solving only one of those by identifying patient candidates actually sometimes not only doesn't help, it actually exacerbates the problem because now you have a site that already doesn't have enough resources to optimally manage the study, and now you're adding to that the need to process a lot of referrals, which may be at varying degrees of qualification, before they could hand it off to the site by patient recruitment firms, and so it exacerbates the problem, and as a result there are breakdowns in overall patient recruitment and enrollment.
Cameron McClusky: Yeah, that's a great answer. It's incredibly interesting to see just how dangerous the ripple effect can be for the rest of the enrollment timeline by having those kind of flawed strategies right out of the gate and have that going into effect, the entire enrollment timeline.
Mark Summers: Yeah, it not only doesn't work in many cases, but it creates a lot of anxiety, and it's very upsetting to sites who want to do a good job with enrollment, and unfortunately it has worked to the detriment of the recruitment industry over the years because sites often don't want to engage with recruitment firms even though sponsors hire them because they know this is going to be a likely outcome of working with the recruitment firm.
Q2: What do you think is the new paradigm in patient recruitment? How can you better prepare for and execute patient recruitment, and how does that lead to an increase in enrollment?
Mark Summers: Well, the new paradigm in recruitment is, it's really ... the old saying everything old is new again, or vice versa, and in this case the new paradigm is “back-to-basics.” If you think of identifying patient candidates for a clinical research study, the logical place for that to really start is at the site. The good way to think about this is using a Concentric Circle model where the innermost circle is comprised of active patients of the clinic. These are patients who are coming through every week for clinic visits and ensuring that those patients are being identified and evaluated for clinical research studies at that site as appropriate, that's the lowest hanging fruit on the tree.
Putting a system in place to do that first and foremost is most important, the next outer ring are inactive clinic patients. These are patients who have been to the clinic, the investigator is perhaps their physician or has been their physician in the past, and those patients just happen to be inactive. They don't have a visit scheduled, or maybe they don't have a visit scheduled for several weeks, and these patients can be identified through comprehensive review of charts, and then the next outer ring are patients of referral physicians for the site.
It's often thought that physicians, especially primary care physicians, are reluctant to refer patients to clinical research studies because they're going to lose that patient, and there may be some truth to that, but the most prominent reason they don't is they just simply aren't aware of a study or they don't know enough about a study to feel comfortable in referring their patients to the study. A resource at the site can address that problem by creating a pathway to that site and providing those education resources that are needed.
The next outer ring would be reaching out into the community around the site, the physical community, within proximity of the site. Patients with a given disease state or medication condition often tend to have patterns of behavior or patterns or interaction with the community, or local patient advocacy groups, local care groups and care settings, and those can be leveraged to interact with those patients and identify candidates for a study.
The outermost rings are the patients who are identified through various forms of media outreach. And there are a couple of other things that are critical factors when thinking about this concentric circle model. Patients in the innermost circle have the closest relationship with the investigator. They have a familiarity because they've been a patient, they know the investigator, they know the practice, and as you begin to get farther and farther out, the familiarity with the practice begins to become less and less, and until you get to the media outreach patients where typically that familiarity is often zero.
There's also an economic aspect to this. Those patients in the innermost circle cost the least to access, and when I'm referring to costs here I'm talking about the cost of implementing this as divided by the number of patient enrollments that are produced by it. Where the outermost rings are the most expensive because you have the cost of the media ads. Even if they're digital media ads that have to be advertised over the number of enrollments, and so it only makes sense to start at that innermost circle and work your way out. And yet, we call that Flipping the Funnel and starting at the site and working out, and yet most of the recruitment industry does the exact opposite: starts at the outermost ring with the most expensive patients, and those patients who have little to no familiarity with the site.
Cameron McClusky: Now, with all that said, do you think this same strategy would work with a global trial?
It does, in fact. It's actually easier to implement in some global studies. In some parts of the world such as Eastern Europe, you have legacy healthcare systems that have established health systems and regions that patients go to the hospital, and you have established referral networks and physicians that are already in place. You have legacy medical record systems, and it's easier to implement in some parts of the world than others.
Cameron McClusky: Awesome. Great job. Let's move onto the third and final question. You and I have both seen a recent uptick in questions during our recent webinars about the financial commitment and strategy of patient recruitment. Questions like, "How much financial incentive is too much? Does your model suggest recruitment at any cost?" Are just a couple of the questions that have recently been asked. With those in mind—
Q3: What is the economic philosophy of this new patient recruitment paradigm?
Mark Summers: Patient recruitment should always be thought of as an exercise in value creation, and what I mean by that is the cost of a patient recruitment program can be amortized over the number of enrollments that it produces to come up with a cost per enrolled patient.
Then those incremental enrolled patients, produced by a recruitment program, shorten the time to enroll the overall study, and it's possible to, through a spreadsheet tool, to monetize the value of that time saved. In other words, to come up with an actual dollar value, and it's relatively straightforward to do that, and so it should always be thought of as an exercise in value creation. You're going to invest in a recruitment program, it's going to produce a certain number of enrollments. That in turn is going to result in a cost per enrolled patient, and then the time savings can be monetized into a value per enrolled patient, and the difference between those two is simply return on investment.
If you're spending $5,000 per enrolled patient or $10,000 per enrolled patient, and you're gaining $100,000 in value in the form of saved time, then you have a 10 to 1 or 20 to 1 return on investment, and that's really the way that patient recruitment program, both the design and implementation of a recruitment program, has to be thought of.
Sponsors always are going to have limited resources. Nobody has unlimited resources, but when a sponsor asks me how much is too much, the answer to that question is relative. The goal is to get the best return on investment and the greatest value, and that starts with going back to the concentric circle model. It only makes sense to produce as many enrollments as possible from those low cost patients because then as you amortize the cost of the recruitment program, as you lower that cost, you're going to increase the return on investment, and maximizing return on investment is what it's all about.
Cameron McClusky: This kind of value story for deploying a recruitment strategy seems like an endless topic that we could go into in the future. It sounds like there's a lot to say about that.
Mark Summers: It is, Cameron, and calculating ROI, planning for ROI, and planning for value creation is something that should be part of planning every patient recruitment program. If it's not part of the planning, and scoping, and budgeting for a patient recruitment program then something is being left out. You're right, it's extremely important.
Cameron McClusky: Awesome. Well Mark, thank you so much for, again, taking some time to sit down with me and for sharing your insight on the landscape of clinical trial patient recruitment. I want to give another special thanks to all of you listening as well and point you to our website for more information on the new paradigm of patient recruitment, wcgclinical.com, where you will find a plethora of webinars and white papers further diving into the topic. We hope you enjoyed your listen and take care.