Drug Safety and Effectiveness Data Access

In recent years, the volume and variety of health-related data have increased exponentially; however, integrating evidence to inform decisions about the safety and effective of use of drugs depends on having timely access to fit for purpose data.

A Drug Safety and Effectiveness Data Access Sub-Working Group was established to develop an approach and recommendations to improve the availability of, and timely access to, health system data for the evaluation of drug safety and effectiveness. This group was designed to support a priority initiative of Canadian Institutes of Health Research (CIHR) and had representation from CADTH, CIHR, Canadian Institute for Health Information, Health Canada, British Columbia Ministry of Health, and the Health Data Research Network of Canada.

The objectives of this group were to identify key data sources, gaps in data, barriers to access data, international best practices for timely data access, and to leverage ongoing initiatives. In order to fulfill these objectives, the group consulted key Canadian data users, data holders, and data access facilitators and reviewed the literature. Case-studies of how COVID-19 incentivized national data sharing in Canada and international best practices were also gathered to inform recommendations and next steps.