Medical outcome trials--large-scale, long-duration clinical trials with hard endpoints, including morbidity and mortality-can answer critical questions about product safety and efficacy and are among the most expensive and logistically challenging trials in the entire product life cycle. They can show long-term safety in therapies for chronic diseases such as type 2 diabetes, rheumatoid arthritis, osteoarthritis, and asthma, and efficacy in those for cardiovascular disease.