Strong Site Selection Leads To Success For A Global Phase III GIST Study

A randomized, double-blind, placebo-controlled Phase III study of Study Drug versus placebo for patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatments.

PRA was selected to conduct a global Phase III gastrointestinal stromal tumors (GIST) study for a top 20 large pharmaceutical client.

GIST is less specialized in the United States (US) compared to 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.

Client communication was particularly complex due to local affiliate involvement in many key decisions. Lack of communication surrounding the client’s expectations for key opinion leaders presented another hurdle for PRA. The client’s training schedule threatened timely site activations.