The numbers vary but multiple surveys confirm what we all know: patient recruitment is one of the most challenging and important aspects of running a clinical trial.
A 2017 Tufts survey reported 27% of clinical research sites fail to enroll a single patient. Of those who enroll, 30% ultimately drop out.
As those patients get harder to come by, CROs have to use new tactics to find, educate, enroll, and retain patients. A few of those strategies include:
- Google and social media ads.
- Data analytics of electronic medical records (EMR).
- Mobile optimization, including click-to-call options and apps for reporting symptoms.
- Patient involvement, such as including a patient on the steering committee.
- Outreach to community groups and disease-centered nonprofits.
Adding to this list, we’ve seen significant improvement in population recruitment through enlisting study navigators. A study navigator, aka patient navigator, clinical trial educator, and similar titles, bridges the knowledge gap between the research site and the patient. With a study navigator by their side, patients better understand every step of the clinical trial process. This helps ease their worries and ups the odds they’ll enroll—and stay enrolled—in your study.
What is a study navigator?
A study navigator is a trained layperson that talks with patients both in their communities and in certain health care settings to increase clinical trial awareness and encourage enrollment. Depending on what’s needed, a study navigator may organize lunches at hospitals or community centers in areas where prospective study participants live. Or, they may reach out to patients after they’ve asked about a study.
When a patient calls about a clinical trial, the navigator demystifies the screening and enrollment process. They walk patients through the diagnostics or clinical visits required to match patients with clinical trials.
When the patient is offered enrollment, the navigator answers questions about screening, informed consent, and other first steps. The navigator may also make travel arrangements in certain circumstances.
Why use a study navigator?
A study navigator acts as the patient’s clinical trial confidante. By answering questions and addressing fears from the beginning, the navigator gains patients’ trust. That trust is important for ensuring patients stay committed through the duration of the trial.
Anxiety around unknown side effects, distrust in the medical or pharmaceutical industry, worries about cost—while the study navigator can’t answer all patients’ questions around these topics, he or she can point them to the people and resources that can.
How we did it
A global regenerative medicine and biopharmaceutical company wanted to increase awareness and provide access channels to patients interested in participating in their clinical trials. The two companies were conducting a Phase 2b clinical trial study to further evaluate the safety and efficacy of their therapy in patients with a neurodegenerative condition.
As part of their patient recruitment process, the sponsors tapped into a research hospital’s patient registry to identify eligible participants. Due to logistical issues, the referrals weren’t getting to the sites. The sponsors were losing valuable patients as a result.
Biorasi became aware of the issue and proposed a study navigator to help improve the process. After IRB approval, the study navigator interacted with interested patients and helped them find a site in their geographical area. When needed, the navigator assisted with travel arrangements. The navigator also listened to concerns from patients, investigators, and site coordinators.
Biorasi also developed a navigator database that includes patient profile information and status: screening visit outcome, surgery date, and communication history, among other fields. Through the database, study navigators can track patients, schedule follow up calls, and create reports that allow us to see trends, success rates, and key metrics.
The study used 51 study locations throughout the United States. Most investigators at those sites went into long periods of inactivity once their initial subject search didn’t yield result. Investigators that coordinated with the site navigator didn’t experience this dormancy.
With the navigator’s help, the research hospital referred about six subjects per month to various sites—38% of all subjects. The sponsors improved their patient recruitment process, saving time and money on an ambitious study. We’ve used study navigators with success on multiple Neurology studies. We look forward to working with navigators in other avenues in the future.
Could your clinical trial participants benefit from a study navigator? Contact one of our experts.