It’s Time to Reinvent the Recruitment Model
Recruitment is a numbers game. But is the industry focusing on the wrong number? Advertising campaigns become shinier and more ubiquitous, yet sites still struggle to enroll patients. No matter how successful those campaigns are, all that really matters is how many referrals ultimately participate in the trial. Enrollment trumps recruiting every time. It’s time to flip the funnel and focus on converting recruits into enrollees.
Sites around the world struggle with clinical trial enrollment. They’ve been struggling for years. But Sponsors, sites and CROs continue to approach recruiting the same way, hoping for different results.
The two root causes of missed enrollment
Let’s take a step back and consider why sites fail to hit enrollment targets. It comes down to one of two reasons:
- Lack of potential participants: The site doesn’t have an adequate pool of patients from which to draw. Most sponsors, CROs and sites focus their efforts, casting a wide net in an attempt to generate a large number of referrals.
- Lack of site resources: Site lacks the resources to handle all the referrals it receives. Many remain unprocessed or are processed incorrectly. It may have access to a robust pool of patients but fail to convert them into enrollees.
Re-thinking conventional recruitment strategy
Sites, Sponsors, CROs and, of course, the recruitment industry, have largely focused on the first problem.
They’ve used that metaphorical recruitment “funnel” the same way for decades. Massive ad buys, glossy pamphlets, social media campaigns, all in the service of getting more recruits. Pour them in the top of the funnel and watch enrollments flow out at the bottom.
At least, that’s the conventional wisdom.
The conventional wisdom is wrong. We’ve all seen the alarming stats about studies closing because they fail to meet enrollment targets.
The current funnel approach no longer makes sense. You may find potential enrollees, but if you don’t address the bandwidth issue, referrals don’t get processed—or are processed incorrectly. Candidates are lost, and the trial is delayed.
It may be tempting to fault sites, but that would miss the point
The point is this: The number that matters most isn’t the number of responses to recruitment efforts, but the number of them converted into enrollees on schedule.
That’s why it’s imperative to flip the funnel and address site capacity and resource issues before launching a recruitment program. It may go against conventional wisdom, but it represents the most logical approach—one we’ve seen work on hundreds of sites over the last few years. It’s a commonsense concept: Don’t start recruiting patients until the site has the capacity to deal with each one, quickly, personally and thoroughly.
Flip the funnel: A strategy, not a catchphrase
But simply deciding to flip the funnel isn’t enough. It requires strategic and tactical planning. The site needs to know what to expect and the staff needs to know what to do. These are just a few of the questions that need to be answered:
- What’s the enrollment target?
- When’s the deadline?
- Do my investigators have a history of meeting their enrollment targets or not?
- How many concurrent studies is the Investigator running? Will he/she need dedicated support for recruitment?
- What are the recruitment sources?
- Will the site handle prescreening? If not, how will that be managed?
- From what time zones will we be receiving calls? How do we staff accordingly?
- How will potential enrollees contact the site?
- What are the steps of the screening process? How will the site manage it?
- How many appointment slots will we need?
- Who will follow up with each patient to ensure lab work is done, consent forms are signed, etc.?
- Which staff members will be accountable for each task?
- Who will follow up on all of this to make sure it’s done—and done correctly?
What works for Site-based recruitment strategies... and what doesn't
Throughout the last decade, we’ve consulted with over 3,000 sites in more than 25 countries, and we’ve seen the mistakes they make, and we’ve seen inverted funnel approach work. Here’s a bit of what we’ve gleaned working with and observing sites as they try to find and enroll the right patients—sometimes successfully, sometimes not.
“Spray and pray” outreach methods are ineffective, outdated—and exceedingly popular. It’s an increasingly lose/lose scenario. If the recruitment strategy fails, obviously the site doesn’t meet its enrollment goals. If it’s a smashing success, the site is deluged. We’ve observed countless examples of extremely effective recruitment campaigns backfiring. The calls, paperwork and processing become more than they can handle. In some cases, a third of referrals are never processed, and fewer than 1% of respondents actually enroll.[i] The successful—and costly—marketing campaign is wasted.
The problem isn’t a shortage of willing participants. In our experience—and various surveys bear this out—there’s no shortage of patients. It’s more complex than that: It’s a matter of matching willing patients to trials. Consider: Depending on the survey, upwards of 73%-87% of Americans are at least somewhat willing to participate in clinical trials[ii],[iii],[iv],[v] Nearly 90% agree clinical trials are important to improving health.[vi] Yet few participate. For instance, just 3% to 5% of eligible adult cancer patients are enrolled in a trial.[vii] That suggests something else is going on.
Poor recruiting practices undermine patient-centricity. Sponsors have made tremendous advances in making clinical trials more patient-focused. Patient-centricity programs are thriving once the trial begins. But none of it matters if they can’t enroll enough eligible patients for those trials. The irony is that one of the biggest hurdles to enrollment is inadequate patient engagement. What’s the point of piquing a person’s interest in a clinical study and then ignoring them? That can be devastating for someone who is pinning their hope for a cure on a clinical trial, and can sour them on future trials.
Success demands high tech and high touch. As trials become more sophisticated and more precise, the need for education and support increases. Sites need to provide more education and support for, say, a cancer immunotherapy trial than they did for an antihistamine trial. Yet, many Investigators and coordinators lack the time or expertise to provide the level of education required for truly informed consent. They can’t answer all the calls from worried candidates. They can’t reinforce the value of the trial. Patients need to be engaged and supported. In our experience, sites often lack the resources to fully engage and educate.
Investigator burnout is a real risk. Failure to meet enrollment targets rates is costly for Sponsors, of course, but it’s also frustrating for Investigators and ultimately leads to burnout. It’s one reason for the increasingly high rates of Investigator turnover—turnover that poses a significant risk to medical progress.[viii]
Outside expertise matters. Sponsors and CROs realize they lack the expertise to help sites with bandwidth issues. When they ask sites to “flip the funnel,” they provide the resources to solve the problem of capacity and address the need for patient engagement. For example, last year we saw a Phase III dermatology study close enrollment 24 months ahead of schedule using this model and rethinking its recruitment strategy.
A new model
Flipping the funnel and providing sites with the resources they need can save weeks on the recruitment side. Trials begin sooner. Retention improves. Sponsors save time and recoup their investment in recruiting efforts.
Doing the same thing the same way and expecting different results is not a good foundation for a recruitment program—or anything else. It’s time to change the paradigm.
[i] PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2018/2019
[ii] General Perceptions and Knowledge on Clinical Research, 2017 Public and Patient Perceptions & Insights Study, Center for Information and Study on Clinical Research Participation
[iii] Public Perception of Clinical Trials survey commissioned by Research!America, 2017
[iv] The CenterWatch Monthly, August 2015; CenterWatch infographic
[v] Understanding Participation and Strategies for Boosting Enrollment, Civis 2018 survey
[vi] Public Perception of Clinical Trials survey commissioned by Research!America, 2017
[vii] “Inadequate Awareness of and Participation in Cancer Clinical Trials in the Community Oncology Setting.“ Oncology (Williston Park). 33(2):54-7. February 15, 2019
[viii] “CTTI recommendations for strengthening the investigator site community,” Clinical Trials Transformation Initiative, Oct. 2017