Recruiting participants and keeping them engaged throughout the entire study continues to be a major industry challenge. It takes 10 to 15 years and up to $2 billion to develop one successful drug. At the study level, 37% of sites miss their enrollment targets, and 15% of sites don’t enroll a single participant. Despite these significant investments in time and money, 90% of drug candidates in clinical trials fail. Getting to the study endpoint quickly is key for sponsors.
Today there is a heavy focus on participant enrollment and identification efforts, but that is only part of the puzzle. Once the participant is enrolled, continuing to support that participant throughout the study can be a strategic advantage. According to industry sources, the average cost to retain a participant in an immunology trial is $35,000 USD, which is why a major sponsor turned to WCG to recruit participants and keep them engaged and successfully enrolled in a multiprotocol immunology study.
Built-for-Purpose Recruitment, Enrollment and Retention Solutions
The sponsor needed assistance enrolling participants who actively presented symptoms of ulcerative colitis or Crohn’s disease—and it needed help across seven different protocols that included two indications and two study drugs.
Eligible participants who were not in flare could not be enrolled, but they needed to be available.
Adding to these challenges was the fact that the indication is highly competitive, with a shrinking pool of patients as more therapies come to market.
Initially, the sponsor tried to recruit participants on its own. After 6 weeks, sites were enrolling, but at a very slow pace that put timelines and study milestones at high risk. With a change in leadership on the
study team, WCG was asked to intervene and get involved with the study. Using retention-focused solutions, WCG provided customized enrollment support to meet participants where they were.
WCG provided site support services that comprised people, process, and technology across the participant journey to ensure each study had the right participants at the right time.
A customized patient identification and recruitment solution enabled the WCG team to identify potential participants through retrospective and prospective chart review, referral physical networking, and media referral processing.
A virtual waiting room was enabled to track eligible participants who were not in flare. WCG Clinical Research Coordinators (CRCs) kept in touch with these individuals, educated them about the study, and let them know what to do when they became symptomatic. This ensured an educated, informed, and motivated pipeline of participants who were ready to enroll the moment they become eligible.
“By having a central point of contact via a WCG CRC, the potential participants knew who to reach out to when their symptoms flared,” said Amy Thue, Associate Director, Project Management, WCG. “The CRCs reached out at scheduled intervals based on each potential participant’s anticipated flare cycle and a relationship was developed which increased engagement and resulted in more patients enrolling in the study.”
In conjunction with the above, a centralized study website was launched via WCG’s My Patient® platform. The study website was customized to support the sponsor’s seven protocols and allowed WCG to monitor the entire participant journey—from initial outreach to the virtual waiting room, and through enrollment. This created a valuable pipeline for the sponsor, ensuring engagement with participants from media outreach to the virtual waiting room and into the trial. This effort was complemented by an IRB-approved secondary screener, which ensured participants coming from outside recruitment vendors were fully qualified before referring them directly to sites.
Benefits of Partnering with WCG
As a result of these activities, WCG identified 58,561 potential participants and enrolled 332 across 17 countries. The average cost per enrolled participant was $35,000, in line with the industry average, and the study closed one month early.
“Chart review, referral physician outreach, and media referral processing were key in the recruitment strategy to find as many potential participants as possible,” said Thue. “WCG CRCs remained in continuous communication with participants to keep them informed and engaged. And, prescreened the potential participants, only sending the most qualified candidates to the sites, reducing site burden while decreasing recruitment timelines.”
Learn more about participant recruitment, enrollment, and retention support offered by WCG.
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