Unicorns do Exist: Finding the Right Patients for Clinical Trials
By: Clinical Partnerships Team
It’s no secret that patient recruitment is critical for a successful clinical trial. From first patient/first dose to data lock, everything rests on enrolling (and retaining) enough participants. Otherwise, costs go up, and so does demand on resources. Treatments take longer to get to market or—worse yet—the trial gets cancelled. But finding, screening and recruiting the right mix of patients for clinical trials takes time and expertise. We’re helping sponsors and CROs improve enrollment, delivering prequalified patients while reducing the burden on sites by providing solutions for several of the top recruitment challenges.
Early on, sponsors and sites are often optimistic about the number of patients they can enroll. Then “Lasagna’s Law” settles in as it becomes clear that the pool of patients who are both eligible and available doesn’t live up to the promise of the feasibility data. Why not? Sometimes the eligibility criteria are too narrow. More often, competition is fierce for eligible patients in promising therapeutic areas like inflammation, immunology, oncology and—especially—rare diseases. In addition, lack of awareness limits recruitment from both directions, as study sites tend to focus on patients they already know, and patients don’t know where to find trials.
Cast a wider net.
Today, social media makes it easier to reach a larger patient population, and technology platforms make it possible to pre-screen individuals efficiently while maintaining privacy. For example, we can provide access to Health Stories Project®, a wholly owned subsidiary of Reverba, which is a sharing community made up of more than 160,000 people with a range of conditions. Many have agreed to share their experiences and to participate in activities such as clinical trial participation, which can springboard enrollment.
But patients need screening, which is resource intensive. Our pre-screening services can solve capacity issues for CROs that have more work than resources. In one of the studies we support, which has restrictive eligibility criteria, we screen-failed more than 1,200 interested study candidates over the course of a year. The clinical sites saved valuable time that they could use to focus on patient care.
Look at the data.
Our pre-screening platform also gives sponsors a unique view into clinical study operations. For example, they can see the impact of their eligibility criteria. If too many potential participants are being excluded, it might make sense to consider a protocol amendment. Precise data also enables sponsors to quickly see whether sites are contacting pre-qualified candidates in a timely manner and converting them to enrolled study participants—and to address any issues that might need to be corrected.
The human touch makes a difference.
Decades ago, futurist John Naisbett coined the phrase high-tech/high-touch, proposing that the success of any technology depends on how deeply it shapes the human experience. In an increasingly digital world, the human element becomes more and more important—and impactful. We want patients, caregivers and clinical sites to have the best experience possible so they will want to participate in your trials. Our compliant software systems are complemented by a highly knowledgeable and compassionate clinical team with extensive experience. Delving deeper into issues of health status versus study eligibility, a Reverba-registered nurse completes the pre-screening process, educates candidates about study participation and answers their questions in a safe environment. Patients and caregivers appreciate the empathy. A Reverba-registered nurse also works diligently with study site teams, who value the technical knowledge and the nuanced information provided by the team.
How we work:
Reverba brings both extensive direct-to-patient experience and tremendous flexibility to the table. Our clinical program team has decades of experience and understands the needs and challenges sponsors face. We are available to help at any point in time, from the beginning of a trial or help accelerate flagging enrollment at certain sites. Our in-house expertise and resources enable us to evaluate eligibility criteria, build a digital recruiting screener for self-reported data, and begin recruiting outreach within 24 to 48 hours.
Our clients value Reverba’s SOC II Type 2/ISAE 3000-certified system that is easy to use and highly flexible. Sponsors can opt to collect HIPAA forms, request lab work to confirm self-reported diagnoses, provide concierge services like paying for transportation to the study site—even scheduling appointments for study coordinators, relieving the study site from these administrative burdens.
Reach out!
If you have concerns about patient enrollment at any point in your clinical trial, find out how we can put our high-tech/high-touch patient experience to work to help make your trial a success. Email us at partnerships@em.reverba.com.