Study Background

Phase 3 randomized, double-blind, placebo-controlled study to validate the efficacy and safety for a drug for the treatment of Pulmonary Arterial Hypertension (PAH). Spanning 26 countries and 191 sites, the trial was expected to screen 385 patients.

Challenges

Anticipated screen fail rate of 33% based on complex inclusion and exclusion criteria. While inclusion / exclusion criteria represent the majority of screen failures, other impediments such as site operational aspects and site training will impact conversion.

Results

Various site resources including, but not limited to, facilitation of prescreening, outline for protocol explanations, investigator training and resources. These resources provided sites with the tools and training to better understand which patients are more likely to qualify before formal screening begun and reduce the burden of sites during the screening process, all leading to less screen fail patients than expected.