Enrolling patients in clinical trials can be difficult. And if you have ever struggled to reach patient enrollment goals at your clinical trial site, you are not alone. There are some strategies, however, that have been proven to boost clinical trial enrollment.
Patient enrollment is a numbers game—the more people you contact and recruit, the higher the chance one of those people will be successfully enrolled in your clinical trial. Thus, the most effective way you can boost clinical trial enrollment is to establish a robust recruitment strategy.
At the heart of most successful site recruiting strategies is the "campaign." A campaign is simply a series of targeted outreach measures against a pre-filtered database of potential recruiting subjects, usually from the site's database. Doing this outreach well, and consistently, is the key to a successful and thriving research site.
In this post, I will describe 8 best practices to running effective patient recruitment campaigns within your patient database, which, in turn, may help boost patient enrollment at your clinical trial site.
Throw Your Patient Recruitment Web Far and Wide
Run broad search criteria in your patient database to create an initial filtered list of prospective patients. Try to filter by criteria that is more broad than the actual inclusion/exclusion criteria within the research study, recognizing that criteria may change. For instance, if a study requires that patients be on metformin 800 mg BID, consider a search against any patient on metformin, even if a lower dose, or even any patient with diabetes, regardless of medication status. Initially searching with broad criteria ensures you are reaching the maximum number of people you can screen.
Standardize the Patient Recruitment Data
Do you have 10 different variations of the same indication in your patient recruitment database – for instance, "Type 2 diabetes," "T2D," "Diabetes Type 2," "Diabetes Type II," etc.? Without standardization, a database can get out of control, leading to potentially missing prospective patients. Consider developing a standard list of indications and medications, and having your staff select from a dropdown of choices, rather than permitting free-form text entries.
Get More Flexible Capacity for Patient Recruitment Through Outsourcing
You may not have the staff to focus on patient recruitment calling campaigns. Or you may, but you may find yourself too busy to get all of it done. Because of the cyclical nature of clinical research, it's a good idea to develop a strategic relationship with a third party recruiting service that you can outsource your calls to. These companies provide a buffer for you, giving you extra recruitment capacity on a per-study basis. Even if you pay out of pocket, you're still much better off paying for the service than leaving revenue on the table from missed randomization opportunities. Remember-- the more patients you contact and recruit, the better your chances for high patient enrollment!
Develop Patient Recruitment Pre-screeners
Protocol eligibility criteria are densely written. Phone screening directly from the study protocol can be difficult, and lead to inconsistent application by different recruiters. Instead, develop a simple, one or two page pre-screener that has basic information about the clinical trial, such as the number of visits, length of time, medication route, and stipend amount; and a series of simplified questions that get to the heart of the study's eligibility criteria. Standardizing a script will improve quality, reduce errors, and make the patient recruitment process more efficient. Be sure to get IRB approval for the phone script!
Start Your Patient Recruitment Campaign With a Text blast, Email blast (or both!)
Why start your patient recruitment campaign start with a text or email blast? You'll instantly surface the most interested patients, allowing you to book several screenings right off the bat. Our clients report up to 10% of text blast recipients respond with some level of interest. A text or email blast will give your patient recruitment an early enrollment boost, create a favorable impression for your sponsor, and give you time to ramp up your calls. It also "warms up" the prospective patients who do not initially respond to the blast, since they will have already received a message from you by the time you reach them on the phone
Make 3 Rounds of Calls (at least)
There is no escaping: it takes multiple attempts to reach prospective patients. Most of the time, when you call, you'll get a busy signal or voice mail box. It's ok to leave a voice mail, but don't expect a return call – well under 10% of voice mails are actually returned. The only way to maximize your reach is to do multiple rounds of calls. Many of the high enrolling sites set a minimum of 3 call attempts – and some as many as 5 – before a recruiter is allowed to "give up" on a prospective patient. Don't miss out on interested patients who could be enrolled just because you did not get ahold of them in the first round of calls!
If you don't reach a patient, why not send a text? Text messages have over a 40% response rate. This means you are much more likely to start a dialogue with patients you can't reach on the phone. You can even do a 1-2 punch, leaving a voice mail and then following up with a quick text message ("I just left a voice mail. We're running a trial for …").
Keep Your Patient Recruitment Funnel Updated
It is important to know how many prospective patients are in what stage of the outreach funnel. In CRIO's Recruitment Solution, we label patients not yet contacted as "Prospects." Once an outreach attempt has been made, the Prospect patient label automatically changes to "Contacting." Once an eligibility conversation has taken place, we would expect the patient to move to a terminal status such as "Ineligible," "Not interested," or "Booked for V1."
It is important you have clear visibility into each stage of your funnel, since doing so will give you the ability to forecast patient recruitment and patient enrollment. For example, if historically 5% of your prospects enroll in the study, and 60% of your Booked-for-V1 patients screen, you can look at your funnel and do some quick math to determine how many patients you're likely to have enrolled by study-end. Being aware of your patient recruitment funnel will inform what additional strategies to deploy to hit your target enrollment number.
The Right CTMS Can Make a Huge Difference in Patient Recruiting
By now, you may have intuited that having the right software system in place is critical. Typically the software to manage clinical trial recruiting campaigns like the one I'm describing is referred to as "CTMS" or "Clinical Trial Management System." CRIO's CTMS system has a Recruiting module that automates all of the functions above, including text blasts, email blasts, and one-off texting. If you're still running your patient database off Excel or Access, it might be time to consider upgrading to a professional software system customized for clinical trial patient recruiting.
Raymond Nomizu is a Harvard-trained lawyer and former clinical trial site owner; during the operation of his site, he realized that there should be a better software solution for clinical trials. This prompted him to co-found Clinical Research IO, whose eSource and CTMS solutions are now considered some of the best in the industry. Read more about us here.