Evaluation of the Drug Safety and Effectiveness Network Program – Long descriptions

Figure 2.1: Grants and Awards Expenditure by Fiscal Year

Figure 2.1 details the spending by fiscal year:

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Figure 4.1: Number of months between query submission and onset of research by submission year

2009 2010 2011 2012 2013
Time from Query submission to onset of research (in months) 24 (2 Queries) 20 (7 Queries) 13.5 (9 Queries) 6 (6 Queries) 4.5 (4 Queries)

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Figure 4.2: Geographic Distribution of the DSEN Teams’ Researchers

Atlantic provinces Quebec Ontario Manitoba Saskatchewan Alberta British Columbia National organization Outside Canada
Percentage share of overall membership 7% 17% 33% 7% 3% 7% 17% 4% 5%

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Appendix B: DSEN Logic Model

Inputs: FTEs, program funds, existing data sources, DS&E research questions, expert knowledge

Activities: Administer DSEN; Translate knowledge; Facilitate networking in drug safety and effectiveness research

Outputs: Prioritized research agenda; Funded research activities (studies, training, etc.); New post-market drug safety & effectiveness evidence); Mechanisms to communicate; Forum/ workshops to share information and communicate results; Publications; Virtual network of post-market safety & effectiveness research

Reach: Research community; Stakeholders; DSEN Steering Committee; Stakeholders/ Research community; Stakeholders

Immediate Outcomes: Research is responsive to priority drug safety and effectiveness evidence needs of decision-makers; Increased evidence on drug safety and effectiveness available to decision-makers; Increased knowledge of post-market drug safety and effectiveness to inform decisions; Greater coordination and collaboration to address evidence gaps

Intermediate Outcomes: Use of DSEN generated post-market evidence to inform decisions regarding drug safety and effectiveness (e.g. drug plan management activities, regulatory policy); Enhanced ability to evaluate the benefits and risks of drugs in the market place (e.g., regulatory activities, drug plan management); Increased capacity (ability to undertake the work) in Canada to undertake high quality post-market research

Long-term Outcomes: Safe and effective drug products; Timely and credible drug product information is available

Ultimate Outcome: Appropriate selection and safe use of drugs (FCSAP Intermediate Outcome)

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Appendix C: Life Cycle Approach Model

The Drug Safety and Effectiveness Network makes new research evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients. Thus it intersects with the post market monitoring and intervention activities of a lifecycle approach to drug regulation by allowing the integration of new information into product vigilance by Health Canada, Industry, Health Professionals and the Public.

A lifecycle approach means that products would be rigorously and appropriately assessed for quality, benefits, harms and uncertainties both before and after they enter the general market.

A well-designed regulatory framework recognizes the critical points in the life cycle of a drug, connects the phases in between those points, and supports information collection, analysis, and communication.

Increased Knowledge

The life cycle of a drug begins with its development by the manufacturer. The manufacturer conducts non-clinical experiments to characterize the structure and activities of the drug. Testing proceeds to cells and animals to learn how the drug interacts with biological systems. Health Canada has opportunities at this point to learn about the manufacturer's plans for clinical testing of the drug on humans. Knowledge gained at this point will provide foresight into the Clinical Trial Application (CTA) and New Drug Submission NDS.

The information required for a CTA could be expanded to include the manufacturer's complete plan for development of the drug. This would enable Health Canada to take a more comprehensive approach to evaluating a clinical trial and enhance Health Canada's understanding of the drug during the NDS review.

The significant amount of work that a drug manufacturer puts into an NDS results in hundreds of volumes of scientific and clinical information. Health Canada reviews this information to make a decision about the safety, efficacy, and quality of the drug. If the drug meets the standards of evidence in these three areas, the review of the NDS results in Health Canada issuing a Notice of Compliance (NOC) authorizing the manufacturer to bring the drug to market.

Continuous Monitoring

Some types of information about a drug are not available prior to marketing. This information includes rare adverse reactions, interactions with other drugs, long-term effects, and effects on patient groups not included in the clinical trials. Hence, the ongoing collection and analysis of information about a drug after it is brought to market is crucial. The information gathered during this phase can change the assessment of the benefits and risks associated with a drug.

A drug can be withdrawn from the market, either by the regulator or by the manufacturer. However, the information that has been generated by the drug can be preserved and used in developing or improving other drugs.

Extraordinary Needs

Some special drugs are developed to meet extraordinary needs and decisions regarding them may have to be based on limited information. These may be drugs for rare diseases, drugs for use in emergencies, for compassionate access, or be promising new therapies. By their very nature, limited or no human clinical information may have been generated for these drugs. Information on these drugs evolves through their use and is essential to their regulation. Collecting and analyzing data on drugs addressing extraordinary needs is challenging, but must be achieved in a progressive licensing framework.


Pharmacovigilance is the process of detecting, assessing, understanding, and preventing adverse reactions or any other problems with drugs. In the past, pharmacovigilance has been implemented after a drug has been marketed and usually only after the identification of a safety concern. Earlier planning to detect adverse reactions and better approaches to managing risks can result in better patient care and reduce the need to withdraw drugs from the market. Planning for pharmacovigilance is occurring in some countries as early as the non-clinical testing stage. The progressive licensing model may incorporate pharmacovigilance planning at an early stage in drug development. See also the discussion paper, Pharmacovigilance Planning.


Effective and timely communication of new information is an important element of life-cycle management. As the regulator, Health Canada may have information prior to other decision makers. A progressive regulatory system is built around information, so it is necessary to provide structured support for communication. Drug information can be complex and the communication of it must make it accessible and useful. The progressive licensing model will support the involvement of users in the sharing and communication of information and realize that different users will have different needs.”

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Canadian Institute of Health Research

DSEN Executive Working Group: Robert Peterson (CIHR); Jean Pruneau (HC); Cindy Evans(HC)

DSEN coordinating Office

DSEN Steering Committee: Aubin, Jane, VP (CIHR); Vacant (CIHI); Evans, Cindy (HC); Glover, Paul (HC); Gray, Jean (Dalhousie U.); Hoffman, Abby (HC); Laupacis, Andreas (U of Toronto); McArthur, Diane (Ontario Public Drug  Programs); O'Rourke, Brian (CADTH); Peterson, Robert (CIHR); Robitaille, Lucie (INESSS); Wells, Diane(Nurse and Health IT Consultant, Sask.); Walman, Barbara  (BC Ministry of Health); Wilhelm, Linda (Patient Advocate); Roos, Noraloo (Manitoba Centre for Health Policy) invited expert

Science Advisory Committee: Robert Peterson (CIHR); Robert Liteplo (HC); Chander Sehgal (CADTH); One representative from each of the Research Teams

CIHR/HC Working Group: Diane Forbes (CIHR); Frances Hall (HC); Robert Liteplo (HC)

Collaborating Centre for Observational Studies: Canadian Network for Observational Drug Effect Studies (led by Samy Suissa and David Henry – 68 researchers)

Collaborating Centre for Prospective Studies:

  1. DSEN Active Surveillance and Evaluation of Adverse Reactions in Canadian Healthcare (led by Bruce Carleton – 15 researchers);
  2. Canadian Network for Advanced Interdisciplinary Methods for Comparative Effectiveness Research (led by Michal Abrahamowicz – 33 researchers);
  3. Pharmaco-genomics of Adverse Events National Team (Michael Hayden – 18 researchers)

Collaborating Centre for Network  Meta-Analysis:

  1. DSEN Knowledge Synthesis Research Unit (led by Sharon Straus – 12 researchers);
  2. DSEN Network Meta-Analysis Team (led by David Moher – 11 researchers);
  3. The Canadian Collaboration for Drug Safety, Effectiveness and Network Meta-Analysis (led by George Wells – 20 researchers)

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Appendix E: DSEN Query Process Map

Step 1: Decision maker submits a Query

Step 2: Initial evaluation by the DSEN Coordinating Office is undertaken

  1. If Query is acceptable, it is forwarded to the next step.
  2. If Query is found to not be in scope or require additional information, it is returned to the submitter who decides to refine the Query or cancel it.

Step 3: Scientific Advisory Committee (SAC) feasibility assessment

  1. If Query is feasible by DSEN team(s), it is forwarded to the next step.
  2. If Query is possibly feasible, but not by DSEN teams, an open call is made to determine if the Query is answerable using CIHR funding tools.
  3. If Query is found to not be in scope or require additional information, it is returned to the submitter who decides to refine the Query or cancel it.

Step 4: Query development and refining

Step 5: Formal submission of the Query

Step 6: The Query is prioritized by the Steering Committee who are informed of the results of the MCDA analysis

  1. If the Query is answerable by the CNODES team, the Query enters into the research mode.
  2. If the Query is answerable by one of the other six teams, a Rapid Funding for DSEN Targeted Research  grant is pursued.
    1. Proposal is peer reviewed and is evaluated by the DSEN CO (can be returned to proposal submitting team for further refinement).
      1. The proposal proceeds to research if approved.
      2. If Query is possibly feasible, but not by DSEN teams, an open call is made to determine if the Query is answerable using CIHR funding tools.
      3. If funding is not approved or no proposals are received, it is returned to the submitter who decides to refine the Query or cancel it.

Step 7: Research results are communicated back to decision makers prior to other dissemination activities being undertaken

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