A systematic assessment of key design and performance characteristics of drug exposure registries requested by the U.S. Food and Drug Administration

ConclusionsThis study suggests clear objectives, patient accrual/retention efforts, adequate analysis plans, and interim reports contribute to the performance of drug exposure registries.

Source: Pharmacoepidemiology and Drug Safety - January 19, 2018 Category: Drugs & Pharmacology Authors: Yanling Zhao, Ellen Pinnow, Jacqueline M. Major Tags: ORIGINAL REPORT Source Type: research