chapter  7
20 Pages

Validation of Biomarkers as Surrogates for Clinical Endpoints

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.