3rd Meeting of the Drug Safety and Effectiveness Network Steering Committee (DSEN SC) Minutes

Meeting: 3rd Meeting of the Drug Safety and Effectiveness Network Steering Committee (DSEN SC)
Date: June10, 2011- Teleconference
Time: 12:30 am - 3:30 pm
Location: CIHR Offices, 160 Elgin Street, 8th Floor, Ottawa, Ontario - Room 8-321

  • Graham, Ian (Canadian Institutes of Health Research)
  • Glover, Paul (Health Canada)
  • Gray, Jean (Dalhousie University)
  • Hoffman, Abby
  • Hunt, Michael (Canadian Institute for Health Information) for J-M. Berthelot
  • Laupacis, Andreas (University of Toronto)
  • McArthur, Diane (Ontario Public Drug Programs)
  • Nakagawa, Bob (British Columbia Ministry of Health)
  • O'Rourke, Brian (Canadian Agency for Drugs and Technologies in Health)
  • Peterson, Robert (Ex-officio, Canadian Institutes of Health Research)
  • Pruneau, Jean
  • Robitaille, Lucie (Institut National d'Excellence en Santé et en Services Sociaux (INESS) du Québec)
  • Turner, Chris (Health Canada)
  • Wells, Diane (Nurse and Health IT Consultant, Saskatchewan)
  • Wilhelm, Linda (Patient Advocate)
Invited Experts:
  • Roberge, James (Canadian Institutes of Health Research)
  • Roos, Noralou (Manitoba Centre for Health Policy)
  • Berthelot, Jean-Marie (Canadian Institute for Health Information)
  • Brochu, Christian
  • Forbes, Diane
  • Jorge, Elisabeth
  • Yasari, Siham

1. Call to Order and Welcoming

1.1. Welcome and Introductions

1.2. Approval of the February 23, 2011 Meeting Minutes

1.3. Approval of Agenda

  • Agenda Approved
  • Conflict of Interest Issues discussion added

2. Business Arising

2.1. Discussion on update the Terms of Reference

The Committee considered an update to the Terms of Reference heading into the second year of activity. It was suggested that the Executive Director be changed from an ex-officio/ observer to a non-voting member of the Steering Committee (SC).

The Committee also entered into a discussion on perceived Conflict of Interest (COI) for committee members, particularly with respect to their role as advisors in and as potential applicants to the DSEN funding opportunities launched. The members discussed the roles and responsibilities and COI requirements of various CIHR committees and agreed that the DSEN SC COI is in line with good COI disclosure and management practices.

The SC agreed that it was too soon to revise the Terms of Reference. The committee will re-consider revising the Terms of Reference in 2012.

2.2. DSEN Performance Measurement Framework for Researchers that are in possession of CIHR grants

Performance Measurement was recognized as very important in demonstrating accountability for use of DSEN funds. One line of accountability is to Treasury Board as DSEN funding comes from separate Treasury Board Submissions and through the Government of Canada's Food & Consumer Safety Action Plan (FCSAP). Consequently, DSEN has a requirement for a performance reporting back with its partners at Health Canada. DSEN is also accountable to report through CIHR against its operational planning cycle to support Roadmap.

It was reiterated that CIHR grants money to researchers, which is different from contracting research. Performance measurement for DSEN research thus will not be based on strict deliverables. The intention in developing a performance measurement framework for DSEN affiliated researchers is to utilize existing CIHR reporting tools and frameworks as much as possible. DSEN will align with established performance policies for researchers who are in receipt of CIHR grants. DSEN has established a funding agreement with the CNODES Collaborating Center, which is signed by the NPI of the grant, to clearly specify the collaborative working relationship with DSEN. These linkages are referred to in terms of full participation within the Collaborating Center structure and meeting the objectives of DSEN's mandate.

The DSEN Coordinating Office (CO) has engaged Public Works and Government Services Canada (PWGSC) to align reporting requirements for use of grant funds under the FCSAP framework with the systems established at CIHR for corporate reporting. A good portion of that work has been done, and the DSEN CO will bring forward an item on Performance Measurement to the next meeting in November.

2.3. Report on 2010 DSEN Collaborative Innovation Forum

Thank you letters were sent directly to Russell Williams from Rx&D and Peter Brenders from BIOTECanada, thanking them for their willingness to help identify researchers from the industry to participate in the November 2010 Methods Forum. The Forum Report was attached for their information. The report is posted on the DSEN website.

3. Priority Setting Process Contract

3.1. Key elements for good practice in research prioritization.

The DSEN CO has undertaken several contracts to seek input and guidance on best practices in priority setting in the health care environment, targeting as much as possible programs with parallel objectives to those of DSEN. Through this work, no process was identified that could be used directly by the DSEN SC to set priorities for the DSEN research agenda.

Key elements are identifying explicit criteria and a clear methodology for use in prioritization to allow for repeatability, transparency, and reasonableness in decision making.

The DSEN CO also had the opportunity to discuss with Drug Plan Managers about how they might see to establish priorities. The objective of this exchange was to determine what other organizations relied upon as important criteria. This work did not suggest any form of ranking. Finally, Dr. Peterson noted that a common DSEN Query Submission Template was still development with the assistance of Health Canada and has been distributed to Provincial Drugs Plan Managers for comment and testing.

3.2. Road map for developing of prioritization process.

The DSEN CO is working to establish a permanent process for prioritization of DSEN Queries, and proposed a two-step Multi Criteria Decision Analysis (MCDA) process for finalizing the Prioritization function of the DSEN SC.

A MCDA framework was recommended as the preferred approach to establishing priorities in an environment with multiple objectives and no natural unit of measurement for outcomes, such as is the case for DSEN. Development of an efficient MCDA tool should serve as a basis of priority setting to guide high level Decision Makers on the DSEN SC in setting the DSEN Prioritized Research Agenda. In considering priorities the DSEN SC would be free to consider additional factors such as the balance of the research investment portfolio and additional strategic consideration.

The first stage would involve the development of the process itself to determine

  • What are the important criteria for prioritization?
  • How to rate queries relative to each other?

To develop the specific items of the process, DSEN proposed to create a Prioritization Working Group (PWG) of persons who will be applying the DSEN knowledge generated. The intent was to have a small group of up to 8 persons with strong representation from provincial sources (i.e. Drugs Plan Managers or people engaged in the Drug Plan decision making process).

The first task of the PWG would be to establish the criteria and weighting scheme for Query assessment and take the framework through a validation step of prioritization by applying the criteria to real Queries. Through this work a guideline for the MCDA process would be created. Once established the guidelines would let for public comment.

The second stage would be the review and approval of the MCDA process and guidance document by the SC. Following which the DSEN CO would initiate a feasibility assessment of existing Queries by the full network of DSEN affiliated researchers including newly funded teams in fall 2011. That analysis would generate a first group of queries for application of the MCDA ranking framework resulting in the DSEN SC being able to establish priorities shortly thereafter.

The Committee discussed examples of MCDA in practice, considering the potential resource requirements, complexity, and expected added value of information to their establishment of the DSEN prioritized research agenda. It was emphasized that criteria development would have to allow sufficient flexibility to allow maintenance of a balance of effectiveness priorities on the agenda. The DSEN SC approved the recommendation to strike a PWG and begin the MCDA exercise.

4. Provincial and territorial engagement

4.1. Pharmaceutical Directors Forum engagement

Dr. Peterson had the opportunity to meet with Pharmaceutical Directors Forum by teleconference in order to discuss the status of DSEN's development. The discussion was productive in establishing preliminary links for the submission of DSEN Queries from the Provinces and Territories. The group identified the need for further engagement to see that high quality queries can be identified. Provincial and Territorial Drug Plan managers indicated interested in having guidelines and templates that will provide a clear understanding on the process for entering a query to the DSEN prioritization process.

4.2 Contract to contact Provinces and Territories

The DSEN CO contracted a series of interviews with Provinces and Territories to further facilitate the identification and the flow of research questions from the jurisdictions. Drug Plan and Program managers clearly indicated that DSEN could provide information on the post-market safety and comparative effectiveness of drugs in use by real and varied populations. Decision makers recognized that a systematic process for identifying the knowledge gaps does not necessarily exist in their jurisdictions. They rely on a number of communications across jurisdictions including with Health Canada and other organizations for their detection on an ongoing basis.

Decision makers indicated that in order to communicate with DSEN, they would benefit from a simple (standard) form, and an ongoing and open submission timeline, with a mechanism for feedback to the group as a whole on those queries submitted. This could facilitate scope of similar needs of the provinces and minimize duplication of efforts, as well as facilitate sharing of best practices.

4.3 Active participation in the 2011 CADTH Symposium, Vancouver

DSEN was presented at the 2011 CADTH Symposium, held in April in Vancouver, where the DSEN CO had a booth and speaking engagement. The Symposium was well attended and gave the opportunity for many avenues to present and explain DSEN. Emphasis was on explaining the DSEN concept, its processes, the structures DSEN is putting in place and how to submit Queries to DSEN. As Chair of a panel presentation including a CNODES researcher and a DSEN SC member, Dr. Peterson saw that participants were able to understand that DSEN represents an independent look at important issues and then comment on the initiative. The DSEN structure was accepted and feedback was positive.

Some questions arose regarding researchers initiating questions to DSEN. It was indicated that really good investigator initiated ideas should be brought to the attention of high level decision makers for consideration to be brought forward through the Query submission process. It was also reiterated that there are many opportunities at CIHR and through other sources of funding where that research is supported and that individuals seeking to research drug safety or effectiveness not undertaken by the DSEN process can still apply elsewhere.

5. Next Steps

Presently, DSEN has one collaborating center (CNODES) that uses one methodology. In August CIHR Scientific Council will vote on the outcome of the June Team Grant Competitions launched in order to see the inclusion of five additional methodologies. Results will be available at the next meeting.

A call for nominations from the DSEN SC of individuals to serve on the PWG will be organized.

Next DSEN SC is schedule for November 30, 2011 by teleconference.

6. Open Discussion

No new items were introduced for discussion

7. Meeting Adjournment

8. Actions Items for DSEN

  • Circulate to Committee a document describing the intention of the Working Group for Prioritization Process and request for nominations
  • Strike Working Group for Prioritization of Criteria
    • part one - process development
    • part two - review and adoption by SC
  • National Curriculum meeting
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