Challenge:

• Sponsor sought enrollment of 5,280 participants, including healthy volunteers and cancer-diagnosed individuals, to develop and validate a cfMeDIP-seq-based platform for early cancer detection. The central lab had processing limitations for samples, so we had to impose a cap of 55 patients enrolled per day. Additionally, to ensure inclusivity, the sponsor requested that we focus on enrolling male subjects aged 60 and older for the final two months of enrollment.

Goal: 

• Accelerate enrollment of 2,050 subjects into the healthy group over a 5-month timeframe through innovative patient recruitment and engagement strategies 

Solution:

• Physicians within the Elligo Site Network partnered in the research process to enhance patient trust and engagement
• Elligo rapidly identified and pre-screened qualified patients via EHR through the Elligo Site Network
• Established Central PI oversight to ensure protocol adherence and streamline communication
• Combined digital advertising campaign and a patient referral program for a targeted multi-channel recruitment strategy
• Regular communication with sites to ensure enrollment targets were hit without exceeding daily caps

Results:

• Elligo successfully met enrollment targets ahead of schedule, achieving award on August 25th, 2022, activation on October 5th, 2022, and First Patient In (FPI) on October 6th, 2022
• Multi-channel recruitment efforts contributed to patient enrollment with 12% of enrolled subject enrolling through Elligo’s strategic digital advertising campaign and 39% of enrolled subjects coming from the patient referral program
• Long-term patient retention enhanced through physician-patient relationship and the support of Elligo Centralized PI