2nd Meeting of the Drug Safety and Effectiveness Network (DSEN) Steering Committee Minutes


Meeting: 2nd Meeting of the Drug Safety and Effectiveness Network Steering Committee (DSEN SC)
Date: 23-02-2011
Time: 8:30 am – 4:30 pm
Location: CIHR Offices, 160 Elgin Street, 9th Floor, Ottawa, Ontario - Room 9-101
  • Graham, Ian (Canadian Institutes of Health Research)
  • Gray, Jean (Dalhousie University)
  • Glover, Paul (Health Canada)
  • Laupacis, Andreas (University of Toronto)
  • Pruneau, Jean for Hoffman, Abby
  • McArthur, Diane (Ontario Public Drug Programs)
  • Nakagawa, Bob (British Columbia Ministry of Health)
  • Peterson, Robert (Ex-officio, Canadian Institutes of Health Research)
  • Robitaille, Lucie (Québec Ministry of Health and Social Services)
  • Evans, Cindy for Turner, Chris (Health Canada)
  • Wells, Diane (Nurse and Health IT Consultant, Saskatchewan)
Invited Experts:
  • Roos, Noralou (Manitoba Centre for Health Policy)
  • Berthelot, Jean-Marie (Canadian Institute for Health Information)
  • O'Rourke, Brian (Canadian Agency for Drugs and Technologies in Health)
  • Wilhelm, Linda (Patient Advocate)
  • Brochu, Christian;
  • Condran, Gary;
  • Delage, Joane;
  • Forbes, Diane;
  • Yasari, Siham

1. Call to Order and Welcoming
Ian Graham

1.1 Welcome and Introductions
Ian Graham & all

1.2 Approval of Sept 17, 2010 Minutes
Minutes Approved

1.3 Approval of Agenda
Agenda Approved

2. Business arising from minutes and update on DSEN funding opportunities
Robert Peterson

An application to the Collaborating Centre for Observational Studies by the Canadian Network for Observational Drug Effect Studies (CNODES) was received, peer reviewed and approved for funding in January 2011. Two demonstration projects were submitted in the CNODES grant proposal, which is comprised of 12 Principal Investigators representing investigators in 8 provinces. At the moment, CNODES is the only Collaborating Center available to respond to DSEN Queries. They will query administrative databases by distributed statistical query packages. DSEN CO anticipates CNODES will address DSEN Queries, plus their two demonstration projects in start up.

Two additional Funding Opportunities for Collaborating Centres (CC) are now posted to CIHR's Researchnet website. DSEN is planning to establish five teams using the Team Grant funding tool. Teams will receive less platform funding than the observational studies CC but will have access to funds that the DSEN CO has set aside for projects. Although it is a competitive process, DSEN still requires applicants to show collaboration and pan-Canadian teams, as well as to describe a demonstration project as part of the grant application.

Discussion arose as to how the separate teams will become Collaborating Centres. It was noted that it is a function of the Coordinating Office (CO) to facilitate communication to bring the teams together under the common denominators of methodologies.

The first batch of queries received will be revisited over time as DSEN teams are established and the feasibility and priority setting processes become finalized. The regulator and provinces have clear decision making roles and responsibilities and that DSEN will not overlap those responsibilities. There was consensus that DSEN should provide evidence, not propose regulatory / reimbursement decisions.

3. Report on the DSEN Interim Science Advisory Committee (DSEN iSAC) meeting on February 1, 2011
Robert Peterson

With establishment of CNODES, DSEN has moved forward on the first round of feasibility assessments for DSEN queries. Dr. Peterson described the process undertaken by an interim Science Advisory Committee, who considered queries only from the perspective of the CNODES methodology. Queries coming to the CO were examined by staff to screen for DSEN scope, before forwarding for feasibility assessment. The feasibility assessment was conducted by researchers involving the originators of the queries. The process was heuristic with the originators of the queries present for questions. Decision makers listened to the assessments of the researchers to gain a better understanding of what is possible and what is not regarding their query.

In future the process will become more complex as DSEN adds different methodological expertise through the funding of additional Collaborating Centres.

4. Strategic operations and directions: Prioritization of DSEN queries

The DSEN SC was provided with the full result of the iSAC feasibility assessment to clarify the scope of activity and discussions undertaken. The DSEN SC then proceeded to review of the queries deemed feasible by CNODES. A discussion ensued as to the requirements for establishing the prioritization framework for the DSEN SC before addressing the queries tabled.

Members of the DSEN SC had questions about the ongoing prioritization process. It was agreed that criteria should be clearly established as well as the criteria for the feasibility assessment. The DSEN CO has a contract underway to assist in development of a prioritization process. The objective is to have and this process ready for the next round of prioritization in fall 2011.

DSEN SC members decided unanimously to move the existing feasible queries forward onto the DSEN research agenda without prioritization amongst the 8 presented.

Study Date Priorized
High-dose statins and the risk of acute kidney injury February 23, 2011
Proton Pump Inhibitors and community-acquires pneumonia February 23, 2011
Proton Pump Inhibitors (PPI) & Clostridium difficile-Associated Diarrhea (CDAD) February 23, 2011
Atypical antipsychotics and breast cancer February 23, 2011
Proton Pump Inhibitors (PPIs) and myocardial infarction (MI) February 23, 2011
Isotretinoin-related congenital malformations February 23, 2011
Atypical antipsychotics and diabetic keto-acidosis (DKA_V4) (risk factors and incidence) February 23, 2011
The prevalence of atrial fibrillation related-hospitalizations February 23, 2011

Following DSEN's transparency objective, ratified queries will be posted to the DSEN web.

5. Report on the Methodologies in Real World Drug Safety and Comparative Effectiveness Collaborative Innovation Forum held by DSEN on November 19, 2010
Robert Peterson

Dr. Peterson presented information on the first formal invitation by DSEN for interaction with the Pharmaceutical industry. The focus of the Forum was on methodologies for conducting post market research on drugs under several streams. Through the forum DSEN was able to bring together industry scientific representatives, regulators, and researchers for a discussion on scientific methods. Feedback from participants indicated that the Forum was a successful event, attended by more than 75 participants.

An objective of DSEN is to provide an independent source of real-world drug safety and effectiveness information that will contribute to ongoing post-market health product surveillance activities; however, this Forum allowed DSEN and the drug development industry to engage in a mutually rewarding discussion in the public domain.

A Forum Report will be posted to the DSEN website.

6. Report on HC/CIHR Discussion on the DSEN Query Process on January 14, 2011
Robert Peterson

Following development of a process for the submission of DSEN Queries by Health Canada, DSEN hosted an event to inform government staff on the status of the DSEN and to further discuss the framework under which their Queries were to be managed in the first round of priority setting. The session offered an excellent venue to exchange information on the processes currently in place. The event allowed both sides to gain a much better understanding as to what was feasible by DSEN and what were the objectives of the queries.

DSEN will now be working to engage the provinces in a similar process. This is expected to facilitate their participation in submitting DSEN Queries. A contract has been let to address needs of provincial drug plan managers and this will be reported back to DSEN SC and the next meeting.

7. Update on activities
Robert Peterson

Dr. Peterson provided an update on upcoming activities being undertaken by the DSEN CO. The DSEN CO has organized a Knowledge Translation Workshop in late March to receive updates on the progress of the recipients of the 2009 Catalyst Grant: Post Market Safety and Effectiveness. This event will invite both catalyst grant researchers as well as scientific/medical officers from Health Canada who were sources of the catalyst grant topics in order to provide for the translational opportunity to be shared. It will also provide the DSEN CO with an opportunity to improve processes for the launch of DSEN project funded grant opportunities.

The DSEN CO will also be hosting webinars on Feb 25th and 28th, 2011 to inform interested applicants about the upcoming Team Grant funding opportunities launched by DSEN earlier in February.

Additionally the DSEN CO is working to develop other funding opportunities addressing capacity building, particularly addressing new investigators. The CO is also meeting with other institutes to discuss development of new occasions for funding and capacity development that will contribute to DSEN's mandate and contribute to their objectives.

8. Open discussion

No new items were introduced for discussion.

9. Next steps
Ian Graham

The DSEN is at an interim stage of development of its structures and processes for the treatment of DSEN Queries.

Next DSEN SC is scheduled for a teleconference June 10, 2011

Meeting Adjourned at 16:30PM.

10. Action Items for DSEN

  • Include DSEN SC TOR in binder
  • Develop further the interim feasibility assessment and prioritization processes and structure for the management of DSEN Queries in Fall 2011
  • Evaluate transparency and conflict of interest issues in feasibility and prioritization processes
  • Expand Provincial engagement to bring balance between Queries addressing issues of both Safety and Effectiveness
  • Circulate the DSEN Query template
  • Develop performance measurement framework for DSEN CC researchers
  • Post Methods Forum report to the DSEN website
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