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 has been carried out in this area, previously no single organization in Canada has had both the mandate and the capacity to systematically conduct "real world" drug safety and effectiveness research required by decision-makers.
CIHR and Health Canada have partnered to establish and expand the Drug Safety and Effectiveness Network (DSEN). The key objectives for DSEN are to increase:
- the evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients
- capacity within Canada to undertake high-quality post-market research in this area.
DSEN has three key components:
- a virtual network of linked Collaborating Centres in post-market pharmaceutical research
- a Coordinating Office to act as a central hub that facilitates and coordinates network operations
- a Steering Committee to provide strategic direction to the network and set priorities for research
DSEN incorporates a variety of mechanisms to exchange research knowledge. The regular interactions among the Steering Committee, the Coordinating Office, decision makers working in regulation and drug plan management, and the research network serve to bring researchers and users of the information together to ensure that the research conducted will address identified information gaps.
New evidence generated via DSEN provides Health Canada and other stakeholders with an important source of information for use in assessments of drug products' safety risks relative to their therapeutic benefits and supports decision-making on public reimbursement, and the safe and optimal prescribing and use of drugs within the Canadian health care system.
- What is the Drug Safety and Effectiveness Network (DSEN)?
- Drug Safety and Effectiveness Cross-Disciplinary Training (DSECT)
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