Postmarket safety of drugs approved by Health Canada on the basis of clinical and surrogate outcomes: a cohort study.

ABSTRACT:

Background

Health Canada approves drugs on the basis of evidence from clinical trials using clinical or surrogate outcomes. This study compares the postmarket safety of these 2 groups of drugs.

Methods

Information about whether clinical or surrogate outcomes were used and the date of market approval were obtained from Health Canada's Summary Basis of Decision documents issued from Jan. 1, 2005, to Dec. 31, 2014. Safety warnings and the dates they were issued were identified through advisories on the MedEffect Canada website. Kaplan-Meier survival curves were calculated to determine the likelihood that drugs in the clinical and surrogate outcome groups would receive a serious safety warning. The time from market authorization to first serious safety warning was compared for t

SUBMITTER: Lexchin J 

PROVIDER: S-EPMC4593464 | biostudies-literature | 2015 Jul-Sep

REPOSITORIES: biostudies-literature