Patient Recruitment Case Study – COVID-19 Vaccine

Patient Recruitment Case Study – COVID-19 Vaccine

ClinicalConnection’s Pivotal Role during the COVID-19 Pandemic Enabled Vaccine Developer to Speed Data Submission to Global Regulators for its COVID-19 mRNA Vaccine in Adolescents

More than a year after a cluster of people in China’s Wuhan Hubei Province first experienced symptoms of a novel coronavirus that would become known as COVID-19, a major vaccine developer had only tested its mRNA vaccine in adults. Securing FDA authorization to inoculate adolescents against COVID-19 became an imperative. During 2020, more than two million minors are known to have contracted the virus. Although most cases in this age group were mild, they fueled the spread of the potentially deadly virus and contributed immeasurably to the disruption in our nation’s schools.

The sponsor quickly launched a Phase 2/3 clinical trial to test the safety and efficacy of the company’s vaccine in the adolescent cohort ages 12 to 17.

Enrollment Challenges:

  • The trial struggled to find adolescent volunteers, getting off to a sluggish start during the 2020 holiday season, and initially with just a limited number of trial centers.
  • Parents were somewhat hesitant to sign-up their adolescent children given the mild symptoms in this age group.
  • The series of two shots given over a 3-to-4-week period was viewed as a disincentive to busy teens, as was the requirement of several blood draws as part of the study.
  • A parent’s consent to their child’s participation could be overruled since children ages 7+ generally had to agree to take part as well
  • Pediatric clinical trials historically enroll at a slower pace than adult trials.

Recognizing the urgency of patient recruitment and the challenges it faced, the Sponsor sought patient recruitment support. The Sponsor contracted a central recruitment partner who in turn engaged ClinicalConnection as a recruitment channel to fulfill enrollment goals. Known for its PatientEdge™ database of motivated clinical trial seekers and long track record of rapidly providing high-quality patient referrals to study centers, ClinicalConnection quickly began referring pre-screened individuals to research sites. Within the 8-week recruitment period, 637 adolescents were screened from ClinicalConnection with 252 being eligible and referred to a research site for follow up. Of these, 109 were randomized into the COVID-19 vaccine trial.

Recruitment Timeline

The high number of randomizations translated to a randomization rate of over 40%, which was vastly higher than the referrals originating from other recruitment channels. Higher randomization rates reduce the workload for research sites and maximize efficiency and speed as well as ROI.

Randomization Rate

Thanks to ClinicalConnection’s rapid recruitment of motivated participants, the Sponsor met enrollment targets ahead of schedule and brought the world one step closer to ending the COVID-19 pandemic.

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