Virtual Phase 4 CTIMP Trial
Case Study
- Zero participants lost to follow-up
- 100% IP shipment compliance
- Trial executed 4 months ahead of schedule
- Enrolment of 125 participants completed within 4 weeks
Overview
A large Consumer Health company contracted with VCTC for a Phase 4 CTIMP Trial of an OTC product to treat the common cold. This single-centre study required the enrolment of 125 participants over a 16-week recruitment period. Participants could be located anywhere in the UK and were identified via digital recruitment. Eligibility criteria mandated treatment initiation within 36 hours of the first cold symptom. The study necessitated a rapid start-up to align with an earlier-than-expected cold season.
The project posed significant challenges, including:
• Recruiting within an accelerated timeline.
• Ensuring compliance with treatment initiation timelines.
• Managing logistical complexities associated with remote participant management.
Tactics
- Dedicated Medical Team: Comprised solely of medics, ensuring professional oversight at all stages
- Rapid Participant Engagement: Contacted participants within one hour of registering interest
- Efficient IP Management: Dispensed investigational product (IP) within one hour of enrolment, with end-to-end IP services completed within six hours
- Flexible Resourcing: Adjusted site team staffing dynamically to match recruitment intensity
- Consistent Follow-Up: Conducted daily follow-ups to confirm diary completion and maintain compliance
- Virtual Investigations: Enabled telemedicine visits and ensured investigator availability from 8 a.m. to 8 p.m., Monday through Sunday, with 24/7 emergency coverage by a consultant-level investigator
Outcomes
- Successfully completed direct-to-participant IP shipments
- Achieved 100% compliance in investigational product delivery
- Enrolled 125 participants within four weeks, far exceeding the 16-week target
- Executed the trial four months ahead of schedule
- Maintained zero participant dropouts, ensuring study integrity
- Received highly positive feedback for the streamlined, participant-friendly approach
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