Surrogate Endpoints And FDA’s Accelerated Approval Process

Abstract

There is interest in approaches allowing more rapid availability of new interventions, particularly for diseases providing risks of death or serious illness. The accelerated-approval regulatory process is intended to address this need by allowing marketing of interventions shown to have strong effects on measures of biological activity, if those measures are potential “surrogates” for true measures of tangible clinical benefit. To use surrogate endpoints and the accelerated-approval process, challenging issues must be addressed to avoid compromising what is truly in the best interest of public health: the reliable as well as timely evaluation of an intervention’s safety and efficacy.