The following is an exclusive interview with the CEO of ePatientFinder, Tom Dorsett, discussing optimizing the recruitment process in clinical trials and how to avoid the unforeseen issues when submitting trials to the FDA.
Interviewer: So why don’t you tell me a little bit about what your organization does from your viewpoint and what you hope to help your clients with.
Tom Dorsett: Our organization focuses really on the continuum between clinical trial protocol design, protocol feasibility, then site selection and recruitment, so we go even beyond just recruitment. We always want to be upstream. We have access to 60 million de-identified patient lives for running the protocol feasibility piece, and we can also target rare disease patients really well, working directly with our electronic health record (EHR) company partners, such as Allscripts. Our model leverages technology, whereas a lot of recruitment companies focus more on marketing, social media, Google adwords, Facebook ads and such, and we leverage data. We use electronic health record data to identify populations of patients, and then we engage their physician in the process. We believe that the physician has a place in this process, especially the patient’s own physician. So we leverage that trusted relationship, and we’re the only company that does both of those, identifiable EHR data as well as the patient-physician relationship.
Interviewer: What are the two big benefits they’re going to get by working with you? Is it going to be better investigators? Is it going to be better outcomes?
Tom Dorsett: We produce the best patient referral in the business. The media companies might see 3 to 5 percent acceptance rate at sites. We see 60 to 78 percent, so that’s huge, and what that means is we’re not sending over 200 referrals and inundating a site with bad leads. It frankly gets those staff members jaded around it all, so what we do is we make sure they understand that this is a whole different type of referral because it’s going through our three-tiered filtering and data analytics process. Those tiers are, first, engaging the data, running that query. The second, engaging the patient directly, we’re reaching out to the patient, letting them know that their own physician has become aware of a new treatment option for them, and then lastly, engaging the patient’s physician. So by the time the patient’s gone through the process, they’re educated on what a clinical trial is. They’re educated on this specific trial, and they feel confident that what they’re doing is a good idea, because of the credibility of the physician.
Interviewer: Well it seems like with those kind of results (and there is a bad stigma in the industry of misleading the patient) it sounds like that one of the keys is you’re really informing them as you go through the process, so you’re not trying to just get numbers in the door. You are in the end, but quality numbers. Is that a good assessment?
Tom Dorsett: Correct, absolutely. And that comes from that filtering process. We’re not just putting an ad out there where patients are going to self-refer.
Interviewer: So if you look at forward thinking now, people are planning for next year, where can you make the biggest impacts? If a client’s reading this article today, and they’re going, “Okay, I love those numbers. I love that.” You said you liked to be in a certain part of the process, so can you just give us a little bit on that?
Tom Dorsett: Yeah, absolutely. So kind of an interesting little secret about this business, this industry, is that you’ll walk around, and you’ll see different recruitment companies, and some of them are doing this very innovatively, like us. But most of us know each other. The sponsors and CROs tend to push trials to these companies that have a kind of a newer offering that are in bad shape, rescue trials that have fallen behind where they’re willing to try everything. But if the trial is non-compelling for the patient, it creates an issue. We can go find those patients all day, but if the trial is fundamentally flawed, we can’t force them to go into the trial. So really for us, we are working through different partnerships to be accessing mainstream healthy trials that aren’t just fundamentally flawed. We do a great job with that, and those are the best ones for us in primary care, women’s health, cardiology-
Interviewer: So, you’re not talking necessarily just niche? You can do both.
Tom Dorsett: Yes, that’s what we want. We want large, healthy trials. I equate it to the Affordable Care Act. If you have nothing but unhealthy patients in there, it’s not financially sustainable. You have to have the healthy patients. It’s the same thing with us. We can do these rescue trials, and we get better and better and better at them as our network grows, but we also need mainstream trials that aren’t flawed, and we also help with protocol refinement now so that we can help the sponsors avoid having those flaws. We call them “gotcha.” That’s a little “gotcha” in the protocol that’ll take out half of the population. It’s one data point, so we’re lower at the addressable market for those patients by half or even more. We eliminate those before the protocol’s approved by the FDA.
Interviewer: Which is giving you more optimal outcomes because you’re not reducing your population.
Tom Dorsett: Yes, and there’s no other feasibility company out there that does that. That’s another niche that actually goes on and can help identify sites and then also perform the recruitment.
Interviewer: So, who do you optimally work with? Who is your best entry point? Is it a director of clinical trials?
Tom Dorsett: Director of operations. We’re working to create more relationships with sponsors directly because what we find is that they get excited about us.
Interviewer: They can bring you in, and they can at least have some influence over what’s going on. The biggest thing is getting the right patients to the right trial. And then, obviously, the second thing is that you can optimize the trial for getting rid of the little pitfalls that might be unforeseen when they go to submit the trial to the FDA.
Tom Dorsett: You got it. That’s exactly it.