ABSTRACT
Biomarkers will become important in the clinic over the years to come, for
several reasons. First, an increasing number of new drugs will have a well-
defined mechanism of action at the molecular level, allowing drug developers to
measure the effect of these drugs on the relevant biomarkers. Second, there will
be increasing public pressure for new, promising drugs to be approved for
marketing as rapidly as possible, and such approval will have to be based on
biomarkers rather than on some long-term clinical endpoint. Finally, if the
approval process is shortened, there will be a corresponding need for earlier
detection of safety signals that could point to toxic problems with new drugs. It is
a safe bet, therefore, that the evaluation of tomorrow’s drugs will be based
primarily on biomarkers, rather than on the longer-term, harder clinical endpoints
that have dominated the development of new drugs until now.
