Drug Safety and Effectiveness Network (DSEN) Update - June 2010

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Volume 1, number 1

Table of Contents

Message from the DSEN Executive Director, Dr. Robert Peterson

As DSEN has now completed the majority of its activities to establish the Coordinating Office infra-structure within CIHR, the focus now turns towards building the network across Canada and solidifying international linkages. Following the operating principle that networks link autonomous entities with a common goal to achieve an outcome greater than the sum of individual efforts, the DSEN role in facilitating, coordinating, communicating, and sponsoring network activities now begins. The DSEN Coordinating Office is fully staffed and has been continuing the foundational work that was begun more than a year ago. The national nomination process to appoint a Steering Committee is drawing to a conclusion and this distinguished and highly capable committee will be announced soon. Meetings with scientific directors of CIHR Institutes have been most rewarding both in terms of advice received and identified opportunities to integrate this new initiative into the overall strategic directions of CIHR. The partnership with Health Canada has been strengthened through on-going, regular meetings and mutual objectives continue to be identified. Taking advantage of close ties with CADTH has potentiated a tremendous resource of research ideas and opportunities for collaboration with provincial and territorial drug plans.

Following numerous preliminary workshops and consultations, CIHR is now preparing the final stages of major DSEN funding announcements. Our timelines are being met and we anticipate having completed activities that result in funded collaborative centers and associated research started this fiscal year. Clearly, the infrastructure funding necessary to build the network is a priority that we will be addressing first. The establishment of a number of collaborating centers with competencies across the spectrum of methodologies, including adaptive, pragmatic, and sequential clinical trial designs; retrospective and prospective epidemiologic studies and systematic reviews; methods for indirect comparisons will be required to meet the needs for real world evidence to support health care decisions. In order for CIHR to meet its full potential in delivering on high quality evidence in support of health policy and decision makers, all of these methods and innovative strategies will be recruited within the DSEN.

Robert Peterson MD, PhD, MPH
Executive Director, Drug Safety and Effectiveness Network

Who We Are

The DSEN is being established at CIHR as part of the Government of Canada's Food and Consumer Safety Action Plan (FCSAP). CIHR is collaborating with Health Canada in the development of the Network, together with stakeholders from across Canada. In Canada and worldwide, there are gaps in information on the safety and effectiveness of drugs used in real-world settings. More information is needed on the safety and effectiveness of drugs when used by diverse patient populations outside the controlled experimental environment of clinical trials. The key objectives for establishing the DSEN are to increase the evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients; and, to increase capacity within Canada to undertake post-market research in this area.

CIHR is establishing three key components: a network of linked research centres in post-market drug 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.

We are Currently Working On

Upcoming funding opportunities:

The DSEN team is building on groundwork set in 2009/10 to further DSEN's research funding program in the two main streams of Centre Funding, and Project Funding. The priority is to launch funding opportunities for the Centre Funding Stream in fiscal 2010/11 to establish the network.

Collaborating Centres (CCs) will be funded through the Centres Funding stream to establish a core structure of linked research centres in thematic areas of research methodologies, each supporting distinctive competencies within the national DSEN initiative. These would include a unique CC for Observational Retrospective Pharmacoepidemiologic Studies along with consideration of CCs for Prospective Surveillance Studies; Prospective Observational Pharmacoepidemiologic Studies; and RCTs, Systematic Reviews, and Indirect Comparisons.

Over the next year, DSEN expects to fund CCs covering the necessary thematic areas of research methodologies. In order to provide a complete picture to the research community on the planned establishment of the CCs, the DSEN Coordinating Office is providing an overview of the funding opportunity approach (including the details on the thematic areas of research methodologies for each CC, launch timelines etc.) in an upcoming workshop. Please check the DSEN website often for the most recent announcements.

Project Funding will provide research funding opportunities based on the priorities identified in the common research agenda by the Steering Committee that are beyond the scope or capacity of research undertaken by the CCs. Funding opportunities will be launched for varying amounts and duration as needed to respond to the research agenda. Project based funding opportunities are currently targeted for launch closer to the end of fiscal 2010/11.

Upcoming events - KT forum:

The DSEN in collaboration with the Canadian Agency for Drugs and Technologies in Health (CADTH) is seeking to create an open forum for pre-competitive discussions on research methods. National and international expertise from different sectors will be invited to initiate interactions in order to identify gaps and innovations in research methods employed in the study of drugs' safety and comparative effectiveness. This approach will facilitate assessment of the safety and effectiveness of drugs already marketed.

The Forum will bring together industry, researchers and policy makers in a neutral environment to discuss methodologies for a high quality science discussion regarding drug safety and effectiveness. This one-day event will offer the opportunity for mutual knowledge exchange and debate on research methods for the study of the safety and effectiveness issues of marketed drugs.

DSEN Governance

The DSEN is currently establishing a Steering Committee (DSC). The regular interactions among the DSC, the Coordinating Office and the research network will serve to bring researchers and users of information together to ensure that the research conducted will address prioritized information gaps.

The DSC will provide strategic direction to the DSEN and set priorities for needed research through the development of a common research agenda. DSEN staff within the Coordinating Office at CIHR are establishing secretariat functions for the DSC. Chaired by the Vice President of CIHR's Knowledge Translation and Public Outreach Portfolio, the DSC will have senior public servant level representation from Health Canada and the Provinces. CIHR invited nominations for twelve non CIHR members to the DSC during February and March (three federal, three provincial and six non-governmental). The Executive Director rounds out the DSC membership. The nomination period is now closed and DSEN expects to finalize the committee membership shortly.

Coming Up Next

DSEN will soon be launching its Sharepoint site to facilitate exchanges with our research community. If you are interested in becoming a member of the DSEN Sharepoint, you can contact Joane Delage at johanne.delage@cihr-irsc.gc.ca to establish your username and password. If you know of others who would be interested to become members of the DSEN list serve or Sharepoint please have them contact Joane Delage.

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