1st Meeting of the Drug Safety and Effectiveness Network Steering Committee (DSEN SC) Minutes
|Meeting:||1st Meeting of the Drug Safety and Effectiveness Network Steering Committee (DSEN SC)|
|Date:||Friday, September 17th, 2010|
|Time:||8:30 am – 4:30 pm|
|Location:||CIHR Offices, 160 Elgin Street, 9th Floor, Ottawa, Ontario - Room 9-101|
|Chair:||Graham, Ian (Canadian Institutes of Health Research)|
|Invited Experts:||Roos, Noralou (Manitoba Centre for Health Policy)|
|Regrets:||Ballantyne, Meena (Health Canada)|
1. Call to Order and Welcoming Ian Graham
1.1. Welcome and Introductions Ian Graham
1.2. Objective of the meeting Discussion
Dr. Graham highlighted the objectives for the DSEN, those for the meeting, as well as the components for integrated Knowledge Translation (iKT). Committee members confirmed their support for the iKT approach within DSEN.
Members of the Steering Committee expressed their expectations and goals for the meeting in terms of clarity, feasibility, timeliness, and usefulness of the information to be developed through DSEN. The formulation of the research questions will be a key part of the process. Practitioners and patients' perspectives should be integrated in the questions that DSEN will address. DSEN will need to set a dynamic agenda with all stakeholders and make the query process clear to all.
Comments were made as to a distinction between research and information and DSEN's role in relation to decision-makers (e.g. it is potential that some of the results could be viewed as information, rather than research). The successful output is seen as integrative in terms of the balance between information and research. It was recognized that the feasibility assessment criteria may be subjective as well as objective. DSEN has a need for support from all decision-makers. Regulatory decision-making will be strengthened by DSEN's activities, but provincial and other decision-makers are equal stakeholders.
Specific criteria should be developed for the feasibility assessment (e.g. pre assessment by the Advisory Committees) and prioritization processes (e.g. prioritization criteria for the Steering Committee) building on existing documents from other organizations.
1.3. Approval of the agenda
1.4. Reaffirmation of the Conflict of Interest Statements
1.5. Approval of DSEN SC Terms of Reference
Following a high-level discussion, approval of the Terms of Reference was moved by Jean Gray and seconded by Andreas Laupacis.
2. DSEN Overview and Progress Update
Following the presentation on DSEN Overview and Progress Update, discussion focused on the lack of homogeneity regarding availability of data across the provinces/territories. DSEN will not be centralizing data but will be building query sets. By engaging data holders, the DSEN will help stimulate the development of best practice data enquiries at the provincial level. The network will be cooperative and not competitive. Data will remain the property of the data holders. The Collaborating Centre for Observational Studies will have access to the information derived from the data. DSEN wants to leverage greater value from existing investments in post-market evaluation and existing administrative data. Other Collaborating Centres will focus on developing prospective data and new clinical trial design methods.
It was mentioned that it is a great idea to integrate administrative data and prospective data since that has never been done very well in Canada.
DSEN has been and will continue to develop linkages with international collaborators but DSEN research funding will only be available to Canadian Nominated Principle Investigators (NPIs).
DSEN funded research results will be disseminated as part of the CIHR Integrated Knowledge Translation agenda. To achieve this, KT and dissemination of results strategies need to be built into the research process.
3. Funding Opportunities
An update was provided on the status and considerations for the future directions of the various
DSEN would like to acknowledge the willingness of CIHR to accommodate DSEN's specific responsibilities under the separate funding envelope.
3.1. Catalyst Grants
The topics for the Catalyst Grants launched in August 2009 did not go through a formal prioritization process. CIHR-DSEN received a good response to this request for applications. Different Institutes inside CIHR partnered with DSEN in this funding opportunity which enabled DSEN to fund all the projects that achieved a fundable scientific ranking within each funding pool. Collaboration with institutes will hopefully continue into the future.
3.2. Collaborating Centre for Observational Studies (CCOS)
Because the CCOS is a directed grant DSEN will be able to work with the researchers in defining the deliverables of the grant. We have specified a single nation-wide application for this centre in order to unify the team and the resources in meeting the objectives of the Collaborating Centre. We will need to see evidence of national access to data for this application to succeed.
A maximum of $3.5M per year over five years is made available for the Collaborating Centre for Observational Studies. The directed grant will be peer reviewed and the process will permit criteria for evaluation and latitude for CIHR to build in performance reporting.
3.3. Collaborating Centre for Prospective Surveillance and Pharmacoepidemiological Studies (CCPSPS)
3.4. Collaborating Centres for RCTs, Systematic Reviews, and Indirect Comparisons (CCRSI)
The other centres (apart from the CCOS) will be based on funding opportunities (FOs) for team grants. The collaborating centres do not need to be national in scope but will need to demonstrate inter-provincial collaboration. There is proposed funding per year for platform support. Project-funding is also available.
The funding process will be competitive and the Centres will need to demonstrate responsiveness to DSEN's priorities.
A discussion followed regarding the objectives/potential research areas for the two CCs. The SC felt that the currently proposed topics may be too ambitious in terms in identifying a Centre that could respond and deliver on the topics. The SC advised that more focused teams for the CCs should be considered that would assist in ensuring effectiveness of the CCs. Committee members provided examples of research areas that would be a greater priority. A consensus emerged around: methods, active surveillance, surrogate outcomes, clinical effectiveness, and treatment options. Systematic Reviews were deemed not a priority as they are very well done elsewhere.
Advice was provided to DSEN regarding the numbers of team grants and the funding cycle for these.
4. DSEN and Real World Safety and Effectiveness:
Examples of Opportunities
4.1. The Research Community
4.2. Health Canada
4.3. The End-Users
DSEN wants to enable research and capacity development and we want to support the development of new methodologies for real world drug safety and comparative effectiveness studies.
Members of the Steering Committee were concerned about the quantity of queries received by DSEN and the prioritization process and suggestions were provided on how to greater input (e.g. going directly to the provinces to increase regional engagement).
5. DSEN Initiatives and Knowledge Translation
The DSEN Collaborative Innovation Forum is an opportunity of inviting industry to become aware of our activities. Focused on methodologies available for drug safety and effectiveness real-world studies, the Forum will be held on November 19, 2010 in Ottawa and will consider observational studies, innovative RCTs, and systematic reviews. DSEN wants to create an open, constructive, and neutral environment where participants can actively contribute knowledge and experience. No funding for this forum will come from the private sector.
6. Strategic Operations and Directions
The Steering Committee will review the prioritization process brought forward by the DSEN Coordinating Office at its next meeting. The Coordinating Office will accept queries and screen for those that are clearly out of scope. A Feasibility Assessment process will be conducted by one of the Advisory Committees. The two domains that will be prioritized will be Safety and Comparative Effectiveness.
SC members stipulated the need to have prioritization criteria to use. DSEN will develop such criteria as well as criteria for the Feasibility Assessment. Once a query is deemed feasible, priority assigning criteria will take into consideration impact, viability, relevance, significance. DSEN SC members will also see queries that were not recommended after the Feasibility Assessment.
At the moment, DSEN does not wish to fix a rigid schedule to receive queries. A template for queries is being finalized by the DSEN Coordinating Office (in collaboration with Health Canada).
7. Next Steps
DSEN will reconfigure the team Funding Opportunities according to advice received from the SC while maintaining the Collaborating Centres network architecture. Funding for multiple teams with priorities around methods, novel RCTs, and active surveillance is still envisioned.
Suggested next meeting early winter, 2011. At that time, DSEN will be report on the CCOS grant peer review. This meeting may be via teleconference or held in Ottawa.
Meeting adjourned at 3:30 PM.
8. Action items for DSEN:
- Share CCs draft Funding Opportunities (summary) with SC members
- See possibilities of restructuring team grants into several grants for CCs
- Share Methods Forum draft agenda with SC members when circulating minutes
- Invite OMOP representative at the Methods Forum
- Develop prioritization criteria and procedures for the initial assessment and final prioritization by the Steering Committee
- Develop query management process (including records of decisions and a log of research results)
- Determine the dates of the next two meetings
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