Reinforcing the social compromise of accelerated approval

Reinforcing the social compromise of accelerated approvalReinforcing the social compromise of accelerated approval, Published online: 03 July 2018; doi:10.1038/s41571-018-0066-3Accelerated approval enables investigational drugs to reach the US market on the basis of their demonstrated effects in unvalidated surrogate measures, only reasonably likely to predict clinical response. To fulfil the social compromise, regulators should ensure that confirmatory trials testing clinically meaningful end points are already underway at the time of approval.

Source: Nature Clinical Practice Oncology - July 3, 2018 Category: Cancer & Oncology Authors: Bishal Gyawali Aaron S. Kesselheim Source Type: research