Publication of confirmatory studies required by Health Canada for drugs approved under a Notice of Compliance with conditions: a cohort study

ABSTRACT:

Background:

Health Canada approves drugs based on limited data (Notice of Compliance with conditions [NOC/c]) and then requires companies to conduct confirmatory studies to validate the drugs' efficacy/effectiveness. The current investigation was carried out to determine whether these confirmatory studies are eventually published and are available to health care practitioners.

Methods:

A list of drugs for which the confirmatory studies had been completed from 1998 to Sept. 30, 2014 was created from 2 published articles that listed NOCs/c and investigated whether they had been fulfilled, the NOC database and the NOC/c Web site. The confirmatory studies for these drugs were determined from Qualifying Notices, agreements between Health Canada and the drug companies. Possib

SUBMITTER:  

PROVIDER: S-EPMC5498478 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature