With drugs costing an average of $800 million and taking 10 years to 15 years to develop, pharmaceutical and biotechnology executives have no choice but to improve R&D productivity and get new products to the market more quickly.
To do so, the clinical-trial process needs to be streamlined for improved efficiency. Hampering efforts, however, is the fundamental nature of research and development.
“Unpredictability is the one feature that is guaranteed to challenge — and derail — project performance in a clinical-development program,” says Lawrence A. Meinert, M.D., MPH, senior VP of global clinical operations for Covance Inc. “Years of efforts have been expended to enhance clinical management throughout the drug-development industry. It is nearly universally understood that clinical trials consistently underperform within the areas of enrollment rates and staffing. The goal is clear, however: meet the numbers established in the protocol that can be easily tracked and measured by the standard…