Expertise in Global Prostate Cancer Trials

Between early 2001 and late 2003, PPD managed and monitored two extensive global Phase III trials in androgen independent prostate cancer (AIPC) patients. These trials were conducted and managed by PPD in 17 countries across North America, Europe, Africa and Australia. Both protocols were designed to evaluate safety and efficacy as measured by time-to-disease progression.

Both studies opened in 2001 and, through active site management and implementation of several key enrollment initiatives, enrollment on both of these studies was successfully met on time. The metastatic AIPC trial accrued 809 subjects in 16 months and the non-metastatic trial accrued 907 subjects in 24 months.

Historically, most approvals for new oncology compounds have been based on traditional efficacy endpoints such as overall survival. Recently, the FDA has stated that they will now entertain NDAs based upon endpoints of delayed time-to-disease progression.

The successful enrollment of these studies with complex protocols and novel endpoints, in a highly sought-after patient population, bears example of a successful PPD/sponsor partnership in implementing a global Phase III oncology trial. This is only one of many successful PPD/sponsor partnerships in oncology, which covers multitudes of novel therapeutic interventions, Phases and tumor types. Our foundation of experience and successes in oncology continues to grow, along with our list of satisfied sponsors.