Canada finally opens up data on new drugs and devices

Abstract

Other regulators should take note of Health Canada’s substantive reforms

Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology

“…CSRs are reports structured according to international guidelines,23 written by sponsors and submitted to regulators, generally as part of marketing authorisation applications, and provide far more detail than journal publications 24. In 2015, the EMA expanded its efforts to proactively publish CSRs to its website following regulatory decisions,25–27 a practice Health Canada also adopted as of 2019 28…”

Achieving greater independence from commercial influence in research

“…The FDA’s finalisation of its enforcement procedure for clinicaltrials.gov reporting requirements should help in this regard 42. Drug and device companies’ ability to hide unfavourable research results43 would also be much reduced if regulatory authorities followed the lead of the European Medicines Agency and Health Canada and released clinical study reports with minimal redactions at the time of drug approval 44. Even more useful would be access to all independent individual participant level data45 along with protocols and analytic codes.…”

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

“…91 However the availability of postmarket safety data remains limited and has not kept pace with improvements in the transparency of premarket data No STATE of the ART in the form of clinical study reports. 113,114 Most regulators allow public access to spontaneous adverse report databases, but other postmarket data, including periodic safety update reports and results of postmarket studies undertaken as a condition of marketing approval, are often unavailable. 107,115 Commercial confidentiality concerns can result in the suppression of information including that which is ostensibly made public (e.g., through redaction).…”

“…After the rofecoxib withdrawal, the FDA undertook to provide the public with access to information on safety signals even before their significance had been determined, allowing independent researchers to review and interpret the data 91 . However the availability of postmarket safety data remains limited and has not kept pace with improvements in the transparency of premarket data in the form of clinical study reports 113,114 . Most regulators allow public access to spontaneous adverse report databases, but other postmarket data, including periodic safety update reports and results of postmarket studies undertaken as a condition of marketing approval, are often unavailable 107,115 …”