5th Meeting of the Drug Safety and Effectiveness Network Steering Committee (DSEN SC) – Minutes

Meeting: 5th Meeting of the Drug Safety and Effectiveness Network Steering Committee (DSEN SC)
Date: Friday, January 20th, 2012
Time: 09:00 – 4:00 (EST)
Location: 160 Elgin, room 9-101
Dial-in: 613-960-7513 (direct number); 1-877-413-4788 (toll free)
Passcode: 30-80-864#
Chair:
  • Graham, Ian (Canadian Institutes of Health Research)
Members:
  • Berthelot, Jean-Marie (Canadian Institute for Health Information)
  • Gray, Jean (Dalhousie University)
  • 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)
  • 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:
  • Henry, David (Canadian Network for Observational Drug Effect Studies, Institute for Clinical Evaluative Studies) (via teleconference)
  • Moody-Corbett, Penny (Canadian Institutes of Health Research)
  • Roos, Noralou (Manitoba Centre for Health Policy) (via teleconference)
Regrets:
  • Hoffman, Abby (Health Canada)
  • Glover, Paul (Health Canada)
Secretariat:
  • Brochu, Christian (Canadian Institutes of Health Research)
  • Forbes, Diane (Canadian Institutes of Health Research)
  • Delage, Johanne (Canadian Institutes of Health Research)
  • Yasari, Siham (Canadian Institutes of Health Research)
Observer: Dwyer, Michael (Canadian Institutes of Health Research)

1. Call to Order and Welcome (Ian Graham)

1.1. Welcome

1.2. Conflict of Interest declarations

No Conflicts of Interest were identified.

1.3. Approval of the November 30, 2011 Meeting Minutes (All)

The meeting minutes were approved but going forward more details of the discussions would be appreciated.

1.4. Approval of Agenda (All)

Approved

2. Business Arising (Robert Peterson)

2.1. Action item (Siham Yasari)

The report of the first Network Meeting held on October 28th 2011 is being finalized and will be circulated to attendees and DSEN Steering Committee (DSEN SC) meeting shortly.

Note: The report has been circulated to DSEN SC on February 8th, 2012 and will also be posted on CIHR website in the very near future.

2.2. CIHR COI for Advisory Committees

CIHR has announced the implementation of a new conflict of interest (COI) policy for all its advisory committees. The DSEN Coordinating Office (CO) does not anticipate that the COI policy update will impact the DSEN SC. CIHR is expecting a revised COI form shortly, at which time DSEN SC members will be required to complete the revised form.

3. Prioritization Process (Robert Peterson)

3.1. MCDA outcome by the Prioritization Working Group

The DSEN SC was presented with the output of a first application of the Multi-criteria Decision Analysis (MCDA) tool by the Working Group on the Prioritization of DSEN Queries. A total of nine Queries were assessed using the tool. The scores were well dispersed, suggesting that the tool has the ability to discriminate between Queries.

Discussion ensued around an observation that the criteria may be more adapted to comparative effectiveness rather than safety. This may be due to a fundamental difference between the populations sizes which could be impacted in the test Queries.

The DSEN SC supported the application of the MCDA tool for one year in its present form, in order to validate the results of the first application. It was suggested that should the tool systematically rate comparative effectiveness Queries above safety Queries then the DSEN SC should explore development of two different sets of criteria to address effectiveness and safety issues separately. It was also suggested that the DSEN CO consider validating the tool using known safety studies where the results have caused specific actions.

Finally the DSEN SC recommended that DSEN also consider further what to do with the non-prioritized queries in terms of feedback to the submitters of the query.

3.2. Presentation of new queries

In order to highlight a full range of issues to be considered by the DSEN SC in establishing research priorities, several of the Queries were presented in detail. The first three queries presented raised important issues in terms of feasibility (availability of the data for Dabigatran, prescribing practices for antipsychotics, and over-the-counter drugs for smoking cessation). The DSEN SC was informed that several of the Queries will be refined through the feasibility assessment, after which DSEN will forward a funding opportunity on ResearchNet. The applications for funding will then be peer reviewed before CIHR's Scientific Council would authorize the release of funds.

3.3. Update on the Prioritized Research Agenda

The DSEN SC agreed that all nine queries presented should go forward through the feasibility assessment, and if determined to be feasible then be promoted to the DSEN Prioritized Research Agenda.

4. Briefing on CNODES activities (David Henry)

David Henry was invited to provide the DSEN SC with an update on the status of implementation for the Canadian Network for Observational Drug Effect Studies (CNODES) following the first anniversary of their start of funding. His presentation discussed the nature of research results that CNODES is likely to produce, the internal structure of the network, their expected level of activity and the outcome of the CNODES demonstration project on high dose statins and acute kidney injury. The presentation closed with an update on the status of research activities addressing the first DSEN Queries underway.

DSEN SC was interested to know about the status of CNODES data access. David Henry explained that at the moment, CNODES doesn't have simultaneous access to all the needed data due to the differences between the provinces Timely access is available in Alberta, Saskatchewan, Manitoba, Ontario and Nova Scotia. Negotiations continue in Quebec and British Columbia. Progress has been made in Quebec but access may be limited to a fixed number of studies in any year. Access in BC remains on a case by case basis.

CNODES funding has been parceled out to researchers affiliated with the provincial data holders. For the time being, it is anticipated that four large studies a year can be done by CNODES. CNODES will implement a rapid response committee and decide whether certain questions can be addressed quickly in some provinces. With time, it is quite likely that CNODES will increase their expected volume of studies conducted per year.

DSEN SC was interested to know more about CNODES knowledge translation practices, particularly with respect to how they intend to address CIHR's open access policy, which requires either publishing in an open access journal or depositing the results in an open access repository. It was noted that there is a CNODES knowledge translation team responsible for developing CNODES practices on knowledge sharing and dissemination, including the CIHR Policy on Access to Research Outputs. CNODES has made progress on some of the queries, and has started providing research results to decision makers. The DSEN CO will monitor the translation of the results of the studies done by CNODES back to the decision makers in need of the information.

5. Performance measurement of the DSEN program (Diane Forbes)

5.1. Reporting to DSEN SC for Advisory Functions

DSEN has established a performance measurement and evaluation framework (DSEN PMEF) for the program to support its ongoing operations. Much of the emphasis in performance measurement is on quantitative information. Additionally CIHR has other reporting systems and supports available for gathering information of use in ongoing planning and operations. These systems and supports will make available valuable information upon which the DSEN CO can report back to the DSEN SC to support their advisory function and to facilitate their engagement in the Program Evaluation. This could be particularly of use in supporting DSEN SC conversations on DSEN research investments, and the proportionate funding of safety versus effectiveness research activities.

5.2. Engagement of DSEN SC in DSEN Program Evaluation

The DSEN SC was presented with the DSEN logic model described in the DSEN PMEF, including the inputs, activities, outputs and immediate outcomes which the DSEN SC may wish to consider in fulfilling their role. DSEN will be using multiple methodologies to evaluate its performance, including document and literature reviews, interviews, surveys, bibliometric analysis, and case studies. The DSEN PMEF identifies the DSEN SC members (both past and present) as key informants to the evaluation of the DSEN program. Their opinions will form an important component of the DSEN evaluations planned for 2012/13 and 2016/17.

5.3. Measuring Impact

CIHR also places a strong emphasis on measuring impact from the research that it funds, and has internal corporate services and personnel who are specialists in evaluating impacts. The CIHR Impact Assessment Framework is complementary to the DSEN PMEF and allows consideration on six distinct impact categories or the development of insights on specific targets of interest. Using this framework the DSEN SC could gain information from a topic or category based viewpoint. It could also be provided with impact assessment information from a specific strategic point of view.

The DSEN SC was interested to understand the consultative process behind the development of the Logic Model. It was explained that model had been validated by a representative group of informants who had similar points of view to the DSEN SC. The DSEN SC then discussed various aspects of impact assessment and the level of detail that they might consider to be of importance in informing their activities. The DSEN SC discussed ideas such as involving drug prescribers in impact assessment and measuring their prescribing behaviors' changes in response to DSEN research outcomes, or tracking citations of DSEN's funded studies in drug formularies as an impact on the decision making process. Case studies were supported as an important tool for demonstrating DSEN's success, particularly when communicating with audiences with lower science literacy.

It was noted that a causal link for impact may be difficult to establish, particularly in the case of a change of policy. It was confirmed that the scope of direct attribution of impacts and longer term outcomes becomes more difficult past DSEN's role in developing and making available new evidence, as DSEN's research may only contribute in part to decisions taken by stakeholders. DSEN SC members acknowledged efforts made by DSEN CO to facilitate interactions between decision makers and DSEN researchers throughout the process. It was also added that these interactions should continue and happen more often if possible either in a formal or informal pattern.

6. Direction on use of existing CIHR tools for funding research within the scope of DSEN (Christian Brochu)

The DSEN was established to fund targeted research and to answer the information needs of decision-makers whereas CIHR has traditionally been funding investigator initiated research.

Despite this fundamental difference, the DSEN SC was informed that DSEN can still use several of the usual CIHR funding tools to reach important program objectives. It was reiterated that DSEN, being instituted within CIHR, does not contract research but must fund research only through peer-reviewed grants and awards. CIHR offers a suite of funding tools that can be adapted to the different needs of DSEN. CIHR funding tools have their utility but can also represent challenges for DSEN, namely longer planning cycles, lessened control on research results, potential of duplication of research, or lack of relevance of certain applications with regards to DSEN's mandate. The specific value attached to use of those funding tools include: opportunity for partnerships, efficiency in launching some types of competitions, and management of DSEN's Grants and Awards budget.

6.1. Supporting studentships and fellowships

The DSEN SC was provided information on how DSEN has used priority announcements to support new investigators working in research areas relevant to DSEN.

6.2. Investigator initiated research in areas with large gaps

Catalyst Grants have been used to good effect to stimulate research in areas where it is clear more information is needed with respect to the safety and effectiveness profiles of drug products, but where DSEN has not necessarily received a targeted Query.

6.3. Partnership on exceptionally expensive research

The challenge of funding RCTs under DSEN was raised in terms of the potential for such large projects to monopolize the DSEN budget to the detriment of funding more numerous studies on priorities that can be addresses with less expensive study designs. Nevertheless, the DSEN CO will be seeking advice from the DSEN SC on research Queries that cannot be addressed by the methods funded in the collaborating centres. Work to see such Queries funded will likely require launch of partnered funding opportunities using more standard CIHR funding tools designed to support such grants.

The DSEN SC was interested to know the budget impact of the grants launched to date. DSEN's funding envelope is still growing and still has room to support additional funding opportunities. DSEN's summary of research investments will be available at the next meeting and will include the round of Catalyst Grants launched in 2011, as well as the outcomes from training and operating awards launched through the CIHR open suite of programs.

Communications on DSEN research funding will need to both define the limitations of the program while identifying the area where opportunities exist. It was also advised that DSEN guard closely the program's scope when moving between the use of DSEN targeted research tools and use of more standard/open research tools. DSEN CO reiterated that it is working to further define RFAs and develop the understanding of those components of DSEN activities which differentiate DSEN grants from the regular operating grants, as is defined in the funding agreements between CIHR and the DSEN funded research teams.

7. Briefing on interface and common interests of DSEN and Canada's Strategy for Patient-Oriented Research (SPOR) (Penny Moody-Corbett)

Penny Moody-Corbett, Director responsible for CIHR's Strategy on Patient Oriented Research (SPOR) provided the DSEN SC with an overview of SPOR. She described SPOR as a partnership program working with provincial and federal governments, which has a broad focus on improving health outcomes through research. The DSEN SC was presented with the overarching objectives for SPOR as well as detail on key elements, including SUPPORT units and SPOR networks.

Under SPOR, patients are to be taken into account in the development of best practices in clinical research and of changes of practices after RCTs. Moreover, the SUPPORT units developed by SPOR will be based in the communities and linked with patients and patients' preoccupations.

The DSEN SC suggested that SPOR work to bring the patient perspective to bear on the funding opportunities launched under SPOR by including patients at both relevance and peer review.

The DSEN SC was interested to have the opportunity to learn further about SPOR as they have been exposed on various levels to this major CIHR initiative. DSEN SC members took the opportunity to ask questions of clarification and provide observations based on their current engagement on SPOR.

8. Open discussion

It was suggested that DSEN should develop a dashboard to show results and to allow follow-up on DSEN's progress. DSEN should also develop a timeline for studies that are currently under way.

The DSEN SC wishes to see a financial picture of DSEN's investments.

The next DSEN SC meeting will take place in late spring, or early summer but a teleconference may be needed in the interim.

Ian Graham announced his departure from CIHR and that a new senior CIHR executive will be appointed to chair the DSEN SC.

9. Actions Items for DSEN

  • Distribute presentations not included in the meeting package to DSEN SC members
  • Circulate October 28 meeting report
  • Investigate development of a dashboard
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