All of these factors contribute to the inflation of new drug development costs, with no relief in sight. Drug development is a lengthy and highly complex process that is driven not only by scientific considerations, but also to a significant degree by regulatory requirements. Recently, much effort has been focused on evaluating the approaches utilized by industry and the regulatory requirements to find areas that could be eliminated or changed in such a way as to speed the drug development process. The process of clinical drug development can be improved significantly by making better use of the data that are collected, a change that may lead eventually to more judicious and more limited collection of data relative to current practices. Contemporary drug development programs often comprise a large number of clinical trials, with an enormous number of observations made within those trials.
Many observers believe that the number of trials and quality of observations are excessive.
The analysis of data from completed clinical trials is often slow and ill-timed for influencing the remainder of drug development and for optimizing doses. If this statement is true, the economics of this ever more competitive industry would dictate that these practices cannot persist into the next century. These characteristics create a need for both scientific and managerial excellence. The pharmaceutical industry has responded more vigorously to the scientific challenge than it has to the managerial demands of research and development. Consequently, most pharmaceutical research and development organizations maintain a traditional functional area orientation, with power and influence residing predominantly in line management.