O4 was contracted to conduct country wide site and vendor selection, country study set-up, site management and patient recruitment. From previous experience, O4 identified some key challenges at the outset:
Extensive eligibility criteria including a MMSE score more or equal to 24 at screening.
Caregiver requirement, duration of study.
The number of procedures including PET and MRI.
In addition, local start-up delayed by 6 months due to delay in radioligand country specific availability.
O4 EngageTM strategy was employed to develop a comprehensive patient recruitment and site management strategy. A detailed subject recruitment campaign was designed with a patient centric approach as the O4 team recognised that despite its complexity, if pitched correctly the study would be attractive to both patient and caregivers as it represented a potential therapeutic strategy for slowing or halting disease progression.
We identified and ‘set-up’ patient identification centres at neighbouring hospitals.
Strong input and practical assistance was received from patient advocacy groups.
O4 AccelerateTM was deployed to enable the establishment of a rapid and comprehensive pre-screening service via O4’s in-house call centre pre-screening team.
Achieved 90% of country enrolment target in just 3 months (planned enrolment period was 9 months) despite 6 months delay in start-up. The screen failure rate was 4:1 whereas globally this was 17:1.