ICON was approached by a drug development sponsor to conduct a global, Phase 3 trial in an adult patients with primary immune thrombocytopenia.

Study description
 

The trial was part of a four-programme study with challenging recruitment timelines due to the COVID impact and disease type. There were inclusion and exclusion criteria differences between site references and central lab for e.g., platelet count. External vendor management was challenging due to multiple vendors (IP, DM, IRT, Lab) assigned which were handled by the sponsor. Several external systems were used including IRT and eCRF which required significant reconciliation. The study also had a high number of protocol amendments.

Weekly recruitment meetings were scheduled to discuss recruitment capacity on a site level and a recruitment roadmap was implemented. ICON kept very close communication lines with the sponsor including daily meetings during data base lock. A flexible monitoring schedule was used with the objective of reducing the SDV backlog given the short timelines for data base lock activities and calculation of the monitoring needs against the SDV backlog.