ABSTRACT

The high risk of product attrition, costly projects, complex regulatory procedures, and lengthy timelines give clinical drug development its unique profile among other industrial and scientific development programs. 1 , 2 The grim statistics, that only one in five drugs entering clinical development will eventually yield a drug product, safe and effective enough to earn marketing approval, underscores a call for more understanding and improvement of clinical drug development, 3 especially given the disproportionate escalation of cost and time involved in this critical process. 4