Wyeth plans to make bold changes to its phase II program, cutting the number of sites participating and using more sites in China, India, Latin America and Central and Eastern Europe. Wyeth also plans to use more sites in emerging regions for its entire clinical program.
Wyeth has a robust pipeline of compounds entering phase II. While phase II clinical trials study a relatively small population of no more than a few hundred subjects, Wyeth uses 50 to 100 sites, 30% of which enroll zero to two patients for phase II trials. This practice is common among most large international pharmaceutical companies. Wyeth plans to reduce the number of sites in a typical phase II program to about 10-20 worldwide...
The key reasons for the overhaul are faster time to market, potentially higher data quality and lower costs. The logistics involved in having 50 to 100 sites participate in a phase II program are formidable. In addition, grant costs in the U.S. and Western Europe are high. Wyeth will increase its use of sites in China, India, Latin America and Central and Eastern Europe, where it will have access to large populations of treatment-naïve patients. In these emerging regions healthcare is centralized at very large hospitals that see thousands of patients per day, which can speed patient enrollment in a clinical trial considerably.
Wyeth will still have sites in the U.S. and Western Europe. The ratio of core countries for not only the phase II program but for Wyeth’s entire clinical program will be about 55% core countries and 45% rest of world. Asia Pacific will make up about 25% and most of that will be in India and China. The company believes that by doing the majority of its phase II trials with only 10 to 20 sites it will cut patient enrollment times in half. Patient enrollment is a major cause of delay in drug development, so cutting that time will mean reducing time to market. In addition, by focusing on fewer sites, Wyeth potentially will be able to get higher quality data, reducing data cleaning times and, in turn, also speeding time to market.
Wyeth has already identified 10 to 15 sites, contracted with five and will sign with five more by year’s end. Wyeth plans to have 15 sites up and running by April 2007. If successful, other large international pharmaceutical companies may follow suit. Wyeth’s daring new phase II initiative could revolutionize drug development as we know it.