Canadian Agency for Drugs and Technologies in Health to host Drug Safety and Effectiveness Network
The Drug Safety and Effectiveness Network (DSEN) – an initiative created by the Canadian Institutes of Health Research (CIHR) and Health Canada - was implemented in 2009 to increase the evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients and to build capacity within Canada to undertake high-quality post-market research in this area.
The program supports the health of Canadians and assists federal, provincial and territorial (FPT) regulators and policy-makers. More recently, the program has supported evidence needs related to COVID-19 vaccine safety and effectiveness for the Public Health Agency of Canada, and other important queries.
A 2019 evaluation of DSEN highlighted the need for improved responsiveness to the evidence needs of decision-makers and called on CIHR and Health Canada to consider a new model and host to address program limitations. A new model design and approach were developed with the input of stakeholders including researchers, decision-makers, and the DSEN Steering Committee (with representation from the provinces and territories, Health Canada, the Canadian Institute for Health Information, the Canadian Agency for Drugs and Technologies in Health (CADTH), citizens, and researchers). These key design elements include ensuring a client-driven approach that is nimble and responsive to decision makers' timelines, with increased accountability, as well as integration of the drug evaluation function within the drug review and approval system.
Following this process, Health Canada and CIHR intend to move forward with a change having determined that the DSEN program would be best situated with and managed by CADTH given its ongoing work with FPT decision-makers, ability to support work through contracts and grants, and integration with the pharmaceutical system in Canada. Although the current DSEN program at CIHR offers high-quality evidence for decision-makers, it is limited in its ability to fund research only though grants and not through contracts, which was identified as one means of introducing greater flexibility and responsiveness to the DSEN model. Given CIHR’s expertise and deep connection with the research community, it would retain the capacity building component of the program.
As an independent, not-for-profit organization that provides health care decision-makers with objective evidence on the optimal use of health technologies, CADTH would be ideally placed to host DSEN. CADTH would build on the work accomplished to date by this initiative and the strong foundation that has been created in Canada to respond to queries from decision-makers about the effectiveness and safety of pharmaceuticals.
We anticipate that the transition will be completed by September 2022. Until then, DSEN would continue to accept new queries through CIHR’s DSEN Coordinating Office at DSEN-RIEM@cihr-irsc.gc.ca and research teams would continue to carry out work on existing queries without interruption.
On behalf of CIHR and Health Canada, we would like to thank CADTH for planning to take on this important function. We also wish to extend our gratitude to the many outstanding researchers from this field who work each day to ensure the health and safety of Canadians.
Tammy Clifford, PhD
Vice-President, Research Programs, Research Programs Portfolio
Canadian Institutes of Health Research
Kendal Weber, Assistant Deputy Minister, Strategic Policy Branch
Frequently asked questions
Why are we planning changes to DSEN?
In 2018-2019, the Office of Audit and Evaluation within the Health Portfolio evaluated the DSEN program. The evaluation highlighted a need for improved responsiveness to the evidence needs of decision-makers and called on Health Canada and CIHR to consider a new model (and host) to address limitations of the current model. More specifically, the evaluation recommended that Health Canada and CIHR consider alternative models capable of delivering more timely and relevant evidence to decision-makers, while continuing to build capacity.
Although the current DSEN program at CIHR offers high-quality evidence for decision-makers, it is limited in its ability to fund research only though grants and not through contracts, which was identified as one means of introducing greater flexibility and responsiveness to the DSEN model.
Would the DSEN program remain the same, just housed at a different host organization?
Under the proposed new host, a new program would be developed and implemented to reflect the recommendations stemming from the evaluation and to position the program for the future. Stakeholders, including provincial and territorial decision-makers, researchers (including current research teams), and other stakeholders and health partners, will be engaged in the design process. Further information will be provided as it becomes available.
Why is CIHR retaining DSEN’s capacity development functions?
CIHR would continue to build capacity in the field of post-market drug safety and effectiveness research through its Health Research Training Platform. It was determined that CIHR is best placed to continue to lead this component as capacity building is a key priority of CIHR’s new Strategic Plan. CADTH does not have this focus as part of their mandate and current work.
When will the implementation of the new model take place?
The transition for the implementation of a new model would take place over the next year. CIHR and Health Canada would work closely with CADTH to support a successful transition and provide advice on processes and operations. All existing team grants would conclude August 2022. It is anticipated that the new program at CADTH would be in place by September 2022.
Will there be interruptions to the country’s ability to conduct research into the safety and effectiveness of drugs while DSEN transitions to a new host and model?
CIHR continues to manage query requests and support research on drug safety and effectiveness throughout the transition period, including COVID-19 queries, which continue to be received and investigated by DSEN research teams.
What will happen to funding beyond August 2022?
Current grants will continue until August 2022. More information will be made available about the post marketing drug evaluation function to be hosted by CADTH over the coming year.
How will interested parties apply for funding under the new model?
The new model would operate with a mix of longer and shorter-term contracts and grants. A request for proposals (RFPs) process will likely be used. Further information will be provided when available.
What will the timing be for any new requests for proposals (RFPs) related to the new DSEN program?
CADTH anticipates that a process for interested parties to submit an application for review and consideration would occur in the early part of 2022.
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