Drug Safety and Effectiveness Network Implementation Progress - August 2009

This past January, the Minister of Health announced that the Government of Canada is continuing to support the Drug Safety and Effectiveness Network (DSEN), first announced in July 2008. The Network will enable more national research on the safety and effectiveness of drugs used by Canadians. It will:

• link researchers through a new virtual network;
• help to co-ordinate a national agenda of research based on priorities identified by decision-makers;
• fund independent research on the safety and effectiveness of drugs in the marketplace; and,
• assess the risks and benefits of drug products that are on the market.

The January 2009 announcement increased the federal commitment for the DSEN to a total of $32 million to be allocated incrementally over the first five years and then $10 million per year ongoing thereafter. The allocated funding provides for $1 million to support related research activities in 2009/2010.

This initiative has enjoyed the support of many stakeholders because it has been known for some time that more information is needed on the safety and effectiveness of pharmaceuticals when used by diverse patient populations in the "real world" - that is to say when used outside the controlled experimental environment of clinical trials. 

CIHR is collaborating with Health Canada in the development of the Network, together with stakeholders from across Canada. DSEN operations will be phased-in over a four year period with full operation achieved by 2012/2013. CIHR is drawing 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 DSEN will have three key components:

• a virtual network of linked centres of excellence in post-market pharmaceutical research;
• a coordinating office established in CIHR to provide leadership and support; 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.

Work to establish these three components is advancing as planned. Highlights of progress to date are provided below.

Steering Committee

• An interim Advisory Committee was established in March 2009 to provide advice on the further development of the DSEN program and the first stages of implementation of the DSEN until such time as a permanent Steering Committee is established in the late fall of 2009. To date the Committee has held five meetings.

Consultations with Stakeholders

• A Conflict of Interest Workshop was held in March 2009. The Workshop included representatives from the public and private sectors and academia knowledgeable of ethical issues related to post-market drug research.
• Consultations on funding opportunity requirements for DSEN to develop and link post-market drug safety and effectiveness research capacity in Canada were held with a national representation of researchers in June 2009.

CIHR DSEN Coordinating Office

• Four of six positions have been recruited (Associate Director, Project Manager, Administrative Officer, and Program Delivery Officer). The search for the Executive Director is currently underway.

Research Funding Activities - 2009 and 2010

1. CIHR Catalyst Grant
   • A funding opportunity was launched on August 18, 2009, to stimulate research on identified gaps in knowledge on drugs' safety and effectiveness using the 2009/2010 DSEN grants and awards funds.
2. Research Network
   • Development of the funding opportunity to establish the DSEN Research Network is currently underway with an expected launch date in the winter of 2010.
3. Priority Research Funding
   • The longer-term DSEN research agenda will be established based on the advice and input of the Steering Committee, once it has been formed.
   • Future research funding opportunities will be based on the priorities identified in the common research agenda.

For more information on the DSEN please see the CIHR website.