Journal of Pharmacovigilance

Recruitment and screening for a multi-site sleep clinical trial: Rolling wave planning leading to study success

4^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials

August 10-12, 2015 London, UK

Marianne Rufiange

Posters-Accepted Abstracts: J Pharmacovigilance

Abstract:

Screening steps of unknown failure rate in a Phase I trial can lead to misestimation of study activity parameters such as recruitment, time, and cost. We set out to develop a model of study planning that would permit the iterative estimation of these activities. First estimates were based on a 53% success rate at Screening Visit 1 (medical history, study criteria), and 66% for Visits 2-3 (sleep problem screening). Multi-step screening of participants with iterative, rolling wave planning was deployed to accurately adjust the flow of volunteers at Screening Visit 1 to adapt to the failure rate at each screening step. The goal was to maintain the right flow of eligible volunteers without surpassing the sleep center bed capacities as the study protocol allowed a strict time window between each visit. Reactivity of the recruitment team was paramount to promptly adjust study activities in response to screening rates communicated. In total, 640 subjects went through Screening Visit 1; of those, 190 qualified and completed Visit 2. Visit 3 was performed on 160 prequalified subjects as per Visits 1 and 2. Of those, 52 subjects were eligible and were randomized. Corrected screening statistics were: 30% success rate at Screening Visit 1, 84% at Visit 2, and 33% at Visit 3. This equates to a challenging overall 8% success rate for this healthy subject sleep trial. Challenges of a multi-step screening for a study with extreme filtering inclusion criteria and strict timelines were successfully met through rigorous communication, and rolling wave planning.