Innovative Recruitment And Retention Strategies For Phase III Rare Cardiovascular Disease Study

Worldwide Clinical Trials was chosen as a partner to conduct a Phase III program from the sponsor in symptomatic patients with PAH treated by either pulsed inhaled nitric oxide or placebo along with standard therapy. In addition to the operational difficulties of the study, we had to recognize and manage medical challenges. The key success in similar studies was a deep understanding of patients’ recruitment and retention, early identification of screening failures, prevention of drop-outs, and recognition of the need for protocol amendment. We took this experience and applied it within this study.