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Executing a challenging Phase II trial
The Challenge
A planned Phase II study requiring 280 participants across 60 sites faced a highly competitive recruitment environment. Patients and sites were choosing between multiple investigational treatments, while the therapeutic area was already known for low patient motivation, poor adherence and high placebo response rates. The sponsor needed to maximise the attractiveness and executability of the study for both patients and sites.
The Approach
Science Enabled engaged patients and trial sites through structured research and advisory boards to identify the practical barriers influencing recruitment, participation and study delivery.
The insights generated were translated directly into protocol, operational and retention improvements designed to strengthen study performance.
The Improvements
Simplified Protocol
Reduced visits and procedures, introduced flexibility in PRO administration and refined inclusion and exclusion criteria.
Improved Patient and Site Materials
Developed tailored materials explaining complex endpoint visits and assessment requirements.
Adherence-Focused Packaging
Redesigned treatment packaging to support patient adherence, including consideration of cognitive challenges affecting the patient population.
Reduced Placebo Response Risk
Implemented insight-led adjustments to reminder communications, educational materials, blinding approaches and randomisation strategy.
Strengthened Site Engagement
Enhanced investigator training focused on recruitment success and ongoing participant retention.
The Results
By removing participation barriers, improving patient support and optimising protocol design before launch, the study recruited faster, retained more participants and required substantially fewer protocol changes.
Recruitment completed
189 days
ahead of schedule
Recruitment completed 42% faster than planned
Retention rate
92%
vs therapeutic area average of 74%
Protocol Amendments
1
global protocol amendment required vs Phase II industry average of 2.6
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Whether you are in early protocol development or managing a challenging recruitment situation, we would be delighted to hear from you.