Combining pre-Approval clinical trials and post-approval spontaneous adverse event reporting for improved safety signaling
Fernanda Bravo1, Lawrence Chen2, John Silberholz3
1UCLA, United States of America; 2UC Berkeley, United States of America; 3University of Michigan, United States of America
We propose a method to enhance post-approval safety surveillance of pharmaceuticals. Clinical trials typically do not provide sufficient evidence for flagging rare safety issues. Our approach combines pre-approval clinical trial results with post-approval surveillance data for common and rare adverse effects to decide whether to flag the rare reaction, weighing type I and type II error costs. We analytically show when our approach is most valuable and numerically demonstrate its effectiveness.