This case study outlines a randomised, double-blind, placebo-controlled Phase III study of a study drug versus placebo for patients with advanced gastrointestinal stromal tumours (GIST) that have received prior treatments.

PRA was selected to conduct a global Phase III GIST study for a top 20 large pharmaceutical client.

GIST is less specialised in the US compared with other global locations, and PRA required a large number of US sites to satisfy the regulatory recruitment target. Site identification was also challenging in Europe, as selection occurred during the summer months. While the study’s fixed-price contract included a buffer with extra sites, start-up delays effectively reduced this buffer.