A Phase II COPD Study Reduces Patient Recruitment Timeline By 90%

An emergency strategy to maintain the project team, motivate sites and accelerate subject recruitment following an unforeseen enrollment stoppage saves a Phase II respiratory study from certain delay and leads to a 90% recruitment timeline reduction.

Project Overview

• Phase II full-service study at 25 sites in the US to enroll 350 subjects with COPD.
• Recruitment period — 12 weeks.
• Treatment period — 12 weeks.
• One in a series of 5 studies awarded to Chiltern from same Sponsor as part of our strong global respiratory portfolio.

Project Challenges

• Manufacturing problems were discovered the day prior to the start of screening requiring immediate unforeseen stoppage.
• There would be a 12-week delay to initiating subject recruitment.
• The setback was communicated at the Investigator Meeting when motivation was at its peak.