Clinical Trials Design Needs To Improve To Cut Delays

Despite shorter review times by the US Food and Drug Administration,the overall time taken in bringing new drugs to the US market is getting longer and longer, according to a recent report from the Tufts University Center for the Study of Drug Development.

This situation is largely due to increases in the average time expended on human drug testing. Between 1990 and 1993, the average FDA review time was 2.7 years, while in 1994 to 1995 this dropped to 1.7 years. Conversely, the average time spent on clinical trials grew from 5.5 years to 7.2 years.

Tufts concludes that this expansion in the human trial segment now means that the drug development process has an average time-to-market of 15 years, and adds that the average drug development cycle can exceed $360 million in research and development expenses. Approximately one half of this time, and one third of this cost, is spent on clinical trials. In addition, up to one-half of all clinical trials fail to generate conclusive results regarding drug efficacy.