High projected screen failure rate due to inclusion criteria.
Exclusion of common concomitant medication and wash-out phase.
Delays in IMP availability resulted in enrolment period commencing in early summer, which raised significant concern relating to a reduced availability of potential participants since sunshine decreases the incidence and severity of atopic dermatitis.
Our specialist team:
Completed robust site level feasibility and selection, organised and conducted an Investigator Meeting and provided extensive training to all investigators and site staff to help optimise screening visits.
Availed of O4’s AccelerateTM to optimise study start up processes and drive enrolment phase timelines, achieving First Site Activation 3 weeks from issuing the first ‘Local Study Packs’ for R&D site team review.
Deployed O4 EngageTM , which ensured customised and focused communication activities across all study stakeholders, secured site engagement and supported patient recruitment & retention.
The subject enrolment rate was higher than Sponsor had anticipated and enabled the study duration to be consolidated by 8 weeks and the Clinical Study Report prepared by O4 ahead of agreed timelines.
195 pts, enrolment completed in 18 weeks, 8 weeks ahead of Sponsor’s original goal (which was set before the IMP delay and summer kick off was known).