In Brief: The Drug Safety and Effectiveness Network (DSEN)

Background

For some time it has been known that more information is needed on the safety and effectiveness of pharmaceuticals when used by diverse patient populations outside the controlled experimental environment of clinical trials. Although research in this area is carried out, no single organization in Canada has both the mandate and the capacity to systematically conduct the "real world" drug safety and effectiveness research required by decision-makers.

In December 2007, the Prime Minister announced the Food and Consumer Safety Action Plan (FCSAP), to introduce "measures on food and product safety to ensure that families have confidence in the quality and safety of what they buy." The FCSAP outlines several measures to meet the Government's objectives, including establishment of the DSEN.

The government is investing a total of $32 million over 5 years and $10 million per year ongoing to establish the DSEN. CIHR and Health Canada are partnering to establish the program. New evidence generated via the DSEN will provide Health Canada with an important additional source of information for use in the ongoing assessments of drug products' safety risks relative to their therapeutic benefits. This evidence will also support decision-making on public reimbursement, and the safe and optimal prescribing and use of drugs within the Canadian health care system.

Building on the conceptual model presented in Medicines that Work for Canadians: Business Plan for a Drug Effectiveness and Safety Network (2007), the DSEN will have three key components: a virtual network of linked centres of excellence in post-market pharmaceutical research; a coordinating office established under CIHR to facilitate and coordinate network operations; and, a Steering Committee which will provide strategic direction to the DSEN and set priorities for needed research through the development of a common research agenda.

CIHR will draw on its existing programs and processes to establish the DSEN. New operational elements will also be developed to address the unique attributes of the DSEN program. The coordinating office will be established as the central hub of the DSEN and will act to develop and sustain the Network. CIHR will administer the DSEN Grant program and support activities to facilitate networking, partnership development and knowledge translation. The DSEN Steering Committee will identify gaps in the information needed to make decisions regarding the safety and effectiveness of pharmaceuticals and promote the translation of research knowledge into actions aimed at improving the health and safety of Canadians. Although the Steering Committee will play an important role with respect to the DSEN, overall responsibility for DSEN operations will rest with CIHR.

Integrated knowledge translation is inherent in the DSEN program design, which will incorporate a variety of mechanisms to exchange research knowledge. The regular interactions among the Steering Committee, the coordinating office and the research network will serve to bring researchers and users of the information together to ensure that the research conducted will address identified information gaps. Health Canada is working to establish program activities to integrate DSEN research activities with the federal government's pharmaceutical policy, regulatory and drug plan management activities.

There will be two main streams of DSEN research funding: Centre Funding, and Project Funding. Requests for Application (RFAs) will be issued in each stream, and Grants will be issued through a competitive process.

CIHR and Health Canada will work together over the long term to engage stakeholders and encourage network growth. For example, partnerships with other organizations funded by federal, provincial and territorial governments, such as the Canadian Institute for Health Information (CIHI), the Canadian Agency for Drugs and Technologies in Health (CADTH), will be pursued to leverage existing public resources (e.g., CIHI's National Prescription Drug Utilization Information System) and expand the DSEN's capacity.

Program Objectives

The key objectives for establishing the DSEN are to increase the available evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients; and, to increase capacity within Canada to undertake high-quality post-market research in this area.