A sponsor was conducting an international double-blind, randomised phase III program for two bronchiectasis studies testing an antibiotic. The sponsor consulted ICON’s respiratory experts for start-up activities, from feasibility through site activation, including patient recruitment and participation for this rare disease. Also, the sponsor needed bacterial infection and sputum sample collection and measurement, which required good coordination, standardisation, and management.

ICON’s Study Start-Up Group (SSU) implemented guidelines, including ICON’s site level metrics, to choose the “best sites” to get an early start on the submissions process. Furthermore, ICON standardised how the patient bacterial infection samples were shipped and analysed. With additional support from the ICON Project Manager, the SSU lead served as a single point of contact in ensuring study start-up issues were negated.

ICON’s SSU group met the first-patient-in goal for both studies. Initial patient recruitment targets were exceeded by several months, and, as a result, the sample size was increased by the sponsor. In addition, ICON experts demonstrated successful management of sputum analysis and bacterial infection measurement locally.

ICON’s international respiratory expertise and Study Start-Up Group provided:

• Acceleration of patient enrolment in rare disease
• Feasibility, start-up, project management
• Clinical and medical monitoring
• Management of sample measurements locally