Results at a Glance - Horizontal Evaluation of the Drug Safety and Effectiveness Network 2014-15 to 2018-19

Program context

The Drug Safety and Effectiveness Network (DSEN) was established in 2009 by Health Canada and the Canadian Institutes of Health Research (CIHR).

DSEN is a network of funded research teams conducting post-market research on drug safety and effectiveness in Canada. It also includes a training program to develop drug safety and effectiveness research capacity in Canada.

Research produced by DSEN is intended to support Health Canada and other Canadian decision makers on targeted oversight and decision making related to human drug products.

DSEN has a budget of $10 million per year, $7.4 million of which is dedicated to grants and awards for the network research teams and its training component. The grants and awards funding is administered by CIHR.

Evaluation approach

This evaluation examined the use, relevance, and timeliness of DSEN research during the period of April 2014 to March 2019.

Evaluation methodology

• Literature Review
• Comparative Analysis
• Key Informant Interview
• Document & File Review
• Query Process Review
• Financial Data Review

Summary of findings

Most decision makers found that DSEN's post-market evidence, while of high quality, was not timely for their decision-making needs, negatively affecting its relevance and usefulness. The main roadblocks to the timely production of information were communication issues within the query process, decentralized leadership leading to key leadership responsibilities not being carried out, the availability of data, and the evolving nature of decision makers' needs.

Other producers of post-market evidence have achieved better results in addressing decision makers' needs in a timely and relevant way. An analysis of the delivery models adopted by these producers identifies key lessons learned supporting the production of relevant and timely information for decision makers. These include streamlined governance that includes decision makers and researchers at the same table, clearly established priorities and agendas, centralized knowledge translation, ready access to data, and dedicated training and capacity building.

Under the Treasury Board Policy on Transfer Payments, CIHR cannot implement some of the above features as researchers are restricted from being involved in strategic planning and priority setting, in order to avoid real or perceived conflict of interest. Furthermore, the grant funding authorities obtained only allow CIHR to fund research through grants and not contracts, which limits the nimbleness of the network to rapidly contract research outside of the DSEN-granted research teams, in order to increase decision makers' access to post-market research. Taking into account these challenges and their impact on DSEN, some key stakeholders have asked if CIHR is still the best host organization for DSEN.

Recommendations and management responses

1. Consider alternative models for delivering timely and relevant evidence to decision makers, while continuing to build on the capacity-building strengths of DSEN in post-market drug safety and effectiveness.
   • Response: Management agrees with the recommendation. Management will identify suitable alternative models and implement the preferred option while continuing to build research capacity.
2. Moving forward, the limitations of the current design should also be addressed as follows:
   1. Streamlined governance that brings researchers and policy makers to the same decision-making table, as this promotes communication and a culture focused on meeting the needs of decision makers;
   2. Firmly established priorities and research agendas, aligned with policy and decision-making needs;
   3. Centralized knowledge translation and a unified approach to project management that includes using templates of analytic plans for frequently used study designs, and standardized approaches to respond to policy maker requests; and
   4. Ready access to data through partnerships with data holders, including private industry (i.e., private insurance companies).
3. Response: Management agrees with the recommendation. Being cognisant of the fact that the actions in response to recommendation 1 are developing a new model, this new model must also seek to incorporate the key elements outlined under recommendation 2.