Drug Safety and Effectiveness Network (DSEN) Newsletter - Winter 2011
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December 2011
Volume 2, Number 2
In This Issue:
Message from the DSEN Executive Director:
As you will learn from this Newsletter, DSEN had an important media event with the announcement of our first collaborating centre: The Canadian Network for Observational Drug Effect Studies (CNODES). This formal announcement followed shortly after the ratification by CIHR Scientific Council of the funding for two additional collaborating centres comprising six teams bringing additional methods expertise to the DSEN research collaborative.
With these new funding announcements, DSEN now engages approximately 150 researchers with a commitment to provide evidence-based responses to queries relating to drug product safety and effectiveness along with opportunities for methods development, training, and knowledge translation. We brought NPI's and their delegates together on October 28th to forge integration across the collaborating centers and to communicate important features of the DSEN mandate and network architecture. A report of this inaugural Network meeting will be posted on the CIHR/DSEN website shortly.
As you will note below, very good progress has been made in developing other operating principles and procedures in order to bring the DSEN into a highly functional Network. We are looking forward to the first of a number of active research responses to drug safety and effectiveness queries to be reported in the next months. With that new milestone, we will anticipate Knowledge Translation activities to garner additional media attention.
Future development of the Network is awaiting results of the most recent funding opportunities which comprise career developm ent awards and catalyst grants directed to the study of marketed drug products in special populations.
Robert Peterson MD, PhD, MPH
Executive Director,
Drug Safety and Effectiveness Network
DSEN Events
Government of Canada Takes Action to Protect Canadian Families
On October 31st, the Honourable Denis Lebel, Minister of Transport, Infrastructure and Communities and Minister of the Economic Development Agency of Canada for the Regions of Quebec, announce, on behalf of the Honourable Leona Aglukkaq, Minister of Health, the funding for the Canadian Network for Observational Drug Effect Studies (CNODES). This Collaborating Centre, which bring together 68 researchers representing 8 provinces (BC, AB, SK, MB, ON, QC, NS and NL), will use healthcare databases maintained by provincial and territorial governments to evaluate the risks and benefits of drugs on the market in Canada.
From left to right: Dr. Hartley Stern, Executive Director of the Jewish General Hospital, the Honourable Denis Lebel, Minister of Transport, Infrastructure and Communities, Dr. Samy Suissa, Director of the Centre for Clinical Epidemiology at the Lady Davis Institute and Dr. Roderick R. McInnes, Director of the Lady Davis Institute at the Jewish General Hospital.
Drug Safety and Effectiveness Network meeting (October 28, 2011)
The DSEN Coordinating Office organized a full day event in Ottawa on October 28th, 2011 which brought together representatives from the entire Network. The objectives of the morning session were to deliver the common vision for DSEN, including clarifications on network operations and to provide an opportunity for DSEN researchers from different Collaborating Centres to interact with each other. In the afternoon, DSEN supported discussions around national education and training needs in the field of Drug Safety and Effectiveness to work towards the identification of priorities for a National Curriculum for post market drug safety and effectiveness training. From our view, the Network meeting was a resounding success. A short report of this event is being finalized and will be available on CIHR website shortly.
Governance
The network of DSEN affiliated researchers is now established
Six new DSEN Research Teams were funded on September 1st,, 2011 through two Team Grant Funding Opportunities. Including CNODES which has been operational since January 1st, 2011, the DSEN network, comprising over 150 affiliated researchers, is now operative for three years.
The Collaborative Centres and Research Teams have been established in thematic areas of research methodologies, each supporting distinctive competencies within the national DSEN initiative:
- The Canadian Network for Observational Drug Effect Studies (CNODES) – contact person is Samy Suissa
- The Collaborative Centre for Prospective Studies which consists of three distinct Research Teams for:
- Active Surveillance - contact person is Bruce Carleton
- Pharmacogenomics of Adverse Drug Reactions - contact person is Michael Hayden
- Comparative effectiveness - contact person is Michal Abrahamovicz
- The Collaborating Centre for Network Meta-Analysis consists of three Research Teams with an expertise in network-metaanalysis.
- Methods Applications and Capacity Development - contact person is George Wells
- Innovative Knowledge synthesis Methods - contact person is Sharon Straus
- Tool for drug Safety and Effectiveness - contact person is David Moher
Figure 1: Regional Distribution of Researchers
Working Group on Prioritization of DSEN Queries
The DSEN CO is in the final stages of completion of procedures for an efficient, transparent and timely response to DSEN Quer ies. Before being promoted to the DSEN Research Agenda, each Query will undergo a two-step prioritization process consisting of an assessment of the scientific feasibility of the project, followed by the prioritization of the Query by the DSEN Steering Committee (DSEN SC), using a Multi-Criteria-Decision-Analysis approach (MCDA). This approach, which allows comparison of Queries based on multiple attributes will provide transparent and reproducible information to the DSEN SC on which to decide about the prioritization of DSEN Queries.
Led by Craig Mitton and François Dionne, experts in the field of priority setting and in the MCDA approach, a Working Group on Prioritization recently defined a set of criteria and weighting process by which the DSEN Queries will be assessed for their relative importance to decision makers across the health care system. The results of this consultation will be integrated into a document describing in detail the query submission and the prioritization processes.
Canadian Association for Population Therapeutics (CAPT) Annual Conference 2012
In order to support its objective to facilitate knowledge translation of new evidence on post market drug safety and effectiveness to relevant stakeholders, DSEN will be present at the 2012 Canadian Association for Population Therapeutics (CAPT) annual conference in Montreal (May 6-8). Two DSEN related sessions are in planning:
- CIHR/DSEN/CNODES will be co-hosting a symposium that is being organized by the Canadian Network for Observational Drug Effect Studies (CNODES). This session will highlight CNODES and its projects, with CNODES-related presentations and speakers.
- CIHR/DSEN will also be hosting a separate academic session of oral presentations for students and investigators conducting research in the area of drug safety and effectiveness. CAPT will be making a call for abstracts in the near future.
More details will be available on the CAPT website shortly.
Drug Safety and Effectiveness Network Steering Committee
The DSEN Steering Committee (SC) met by teleconference on November 30, 2011, at which time they were provided with information on the successful applicants to the DSEN funding opportunities launched in 2011 to establish the DSEN Collaborating Centres for Prospective Studies and Network Meta-Analysis. The DSEN Coordinating Office also provided information on the first Network meeting, where the teams presented themselves and their demonstration projects. The results of these competitions are available on CIHR's website.
The DSEN SC was given a presentation by Craig Mitton and Francois Dionne, who facilitated the Working Group on Prioritization of DSEN Queries. They described a multi criteria decision analysis framework that was developed by the working group specifically to help the Steering Committee in developing the DSEN research agenda. This framework will be made available on the DSEN website for information and comment in Winter 2012.
The DSEN SC was also presented with information on CIHR's Research Reporting System (RRS), and how DSEN will utilize this system to facilitate performance measurement and evaluation of the DSEN program as a whole.
The next scheduled meeting of the Steering Committee will be in Ottawa on January 20, 2012.