You don’t know what you don’t know.
That’s probably true in general, but it’s most certainly the case when it comes to clinical trial recruiting. I learned it the hard way.
I’ve spent my entire professional career in clinical research. I started on the academic medical center site side, and I would say I have a deep understanding of what’s involved in running a study from that perspective. Later, I moved to the sponsor side and learned so much more about planning and executing a trial. But—although I didn’t know it at the time—I’d never truly grasped patient recruitment.
Recruitment is one of the things sites and sponsors just do. Everyone thinks they know what it means. But it’s so much more complicated than they imagine. I remember helping write a clinical trial years ago when I first started out. We were confident: We knew the locations. We understood the disease prevalence. We started the study. We didn’t recruit one single person.
Eventually, I joined WCG ThreeWire. Within a couple of weeks, I realized how much I didn’t know.
It’s all about driving recruitment
Recruitment is what drives the study. No patients, no research, right? But too often, recruitment ends up on autopilot. Sites, sponsors and CROs know they need to do it, but they don’t really consider all the implications or differing strategies to recruitment. They tend to take a one-size-fits-all approach.
But one size doesn’t fit all.
Successful, results-based recruiting demands a customized approach. Think about it: Recruiting for a cancer therapy that could benefit thousands of patients looking for a treatment isn’t going to be the same as recruiting for a vaccine trial in a healthy population.
Anytime you work with a healthy (but at-risk) population, as in many vaccine trials, you are asking someone to participate in a study that, frankly, offers more risk than reward. We’re asking them to take that altruistic approach to clinical research. Understandably, this can be a difficult population to recruit.
Because the potential volunteer doesn’t have the disease, and may not even know they are at risk, we’re actually trying to create awareness first—and creating awareness is not the same as creating a response.
In a recent large vaccine trial, we ended up focusing on having extended conversations. WCG ThreeWire Enrollment Assistants (EAs) talked about the potential risks of participating, why the study is important, how the participants will help advance scientific research, etc. It was a lot of effort—thousands of one-on-one conversations. We met the recruitment goals not because of advertising, not by offering the hope of clinical benefit—but by creating that human connection and then making the case for participation.
Vaccine trials can go on for many years, so our EAs aren’t just focused on recruitment; they are creating the framework for a long-term relationship. They are keeping participants engaged, reminding them in subtle and overt ways that even though they’re not seeing the doctor for several months, they’re still essential to the study, and we still care about them.
Birthday cards, thank-you notes, reminder calls, greeting the participants at the door of the clinic... it’s all part of creating that bond. It’s meaningful and—above all—genuine.
Of course, building trust is essential for any recruitment effort. But the tactics—and even the strategy—will be different each time. Again, think about the difference between a trial for a prophylactic vaccine vs. one offering a potential treatment—even the promise of a cure.
Different drivers, different diseases, different strategies
Whether it’s Crohn’s or atopic dermatitis or endometriosis, these individuals are undergoing some sort of treatment, but it just isn’t meeting the need and they’re willing to try something else.
Unlike with a vaccine trial in healthy subjects, you don’t need to raise awareness or drive home the value of the research. They know. So here, EAs are building trust, and inspiring confidence in the patients that we understand their condition. For the sponsor, that becomes particularly important; there’s strong competition for these patients.
And then there are those indications for which you need to recruit a vulnerable population. Alzheimer’s trials are a good example. Often, we’re dealing with a caregiver as well as a patient. Recruitment, enrollment and retention—they all take on a different tenor. Too often, sponsors and sites will make a few changes—for instance, around informed consent—but for the most part, the recruiting strategy is the same.
That doesn’t make sense.
To meet enrollment targets, sponsors, sites and CROs need to customize the strategy and the tactics. And that’s almost impossible to do while juggling the hundreds of other aspects of launching a trial.
With decades of combined expertise on the clinical, site, sponsor and CRO levels, WCG ThreeWire experts are able to see all the pieces come together and—perhaps more importantly—which pieces are being overlooked.
We’re able to really understand how we can fit in, and what gaps we could fill, and what we need to do in order to have a successful study recruitment.
We live it, we breathe it and we study it. Truly understanding and applying the theory of patient recruitment is a specialized skill. I hate to be clichéd, but it’s both an art and a science.
Sponsors need that specialized perspective, but hiring an outside firm doesn’t necessarily solve the problem. I’ve seen so many take the approach, “We’re going to throw the kitchen sink at this!”
The idea of leaving no stone unturned is great, but clinical trial recruitment demands a more surgical approach. The goal is to find the right patients, not every patient you can.
We don’t want only eyes on an ad; we want bodies in a trial.
We understand recruitment is always a bit of a numbers game, but we’re driven to get the right patients actually enrolled.
Too many firms only report on the top of the funnel—how many people saw a particular ad, how many clicked through, etc. That’s great information to have, but that’s not the same as an enrolled patient.
Anyone can get eyes on an ad. Getting the whole body in the clinic is considerably harder. It’s the difference between going through the motions and getting results.
There’s so much to know about recruiting. We know it.
To see how our customized recruitment solutions can help your study reach enrollment 5x faster, visit https://www.wcgclinical.com/services/patient-engagement/.
About the AuthorMore Content by Tyler Bye | Associate Director, Program Management