Drug Safety and Effectiveness Network First Meeting

Government Conference Centre, 2 Rideau Street, Ottawa, ON

Meeting Report

October 28, 2011
Ottawa, ON


Background

DSEN has two main objectives:

  1. to increase the evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients; and,
  2. to increase capacity within Canada to undertake high-quality post-market research in this area.

To fulfill these objectives, DSEN Coordinating Office organized a full day event in Ottawa on October 28, 2011.

Objectives

The objectives of the morning session were to deliver the common vision for DSEN, including clarifications on network operations. 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 and the establishment of a working group to carry this forward.

Meeting Summary

The meeting, held in Ottawa on October 28, 2011, was attended by 31 participants face to face and 2 others by teleconference. Attendance was represented by individuals from:

  • Canadian universities funded under DSEN envelop or with interest and expertise in areas relevant to DSEN mandate
  • Public sector: CIHR, Health Canada, BC ministry of Health Services
  • Research sector: CADTH

The meeting had a morning and afternoon session with different objectives that will presented in this report.

The morning session aimed at presenting DSEN common vision, explaining Governance structure of DSEN Collaborating Centres (CCs), developing a common understanding among DSEN CCs and clarifying Granting process (agenda is attached in Appendix 1).

The afternoon session providing an opportunity for DSEN CCs and the Drug Safety and Effectiveness Cross-Disciplinary Training Program to discuss the needs, priorities and mechanisms for developing training opportunities for faculty and graduate students in the DSEN CC specialty areas. All CCs recognized that it was important that training to develop drug safety and effectiveness research skills encompass a wide range of topics spanning biopharmacology, specific research methodologies, medical pathophysiology, clinical therapeutics, drug regulatory processes and policy, and general research skills. Different learning modalities were discussed and the groups recognizes and a combination of modalities would likely be needed to meet the needs of learners from a variety of background and individualized interested. Leveraging the expertise across DSEN was felt to be beneficial in working towards developing a national drug safety and effectiveness curriculum.

The AM session summary

Dr. Robert Peterson, DSEN Executive Director gave the opening remarks and presented the objectives of the day followed by an introduction to the DSEN CCs and Research Agenda. Dr. Peterson also gave an overview of DSEN components, explained the Query prioritization process and invited the investigators from different teams to study the proposed Query and respond within the following 2 weeks so that the DSEN Coordinating Office (CO) could schedule a teleconference to discuss its feasibility with available methodologies accessible within the entire network.

Following the morning break, representatives from all the DSEN CCs gave an overview of their team, explained briefly their governance and demonstration project. The presentations were given as follow:

  1. Canadian Network for Observational Drug Effect Studies (CNODES) / Drs. David Henry and Colin Dormuth
  2. Canadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research (CAN-AIM) / Drs. Michal Abrahamowicz and Sasha Bernatsky
  3. Pharmacogenomics of Adverse Events National Team (PREVENT) / Drs. Colin Ross and Richard Kim
  4. DSEN active Surveillance and Evaluation of Adverse Reactions in Canadian Healthcare team (DSEN-SEARCH) / Dr. Ricardo Jimenez
  5. Knowledge Synthesis Research Unit (KSRU) / Dr. Sharon Straus
  6. NETwork Meta-ANalysis team(NETMAN) / Dr. Lise Bjerre
  7. Team for Network Meta-Analysis (TNMA) / Dr. George Wells

Over lunch break, the CIHR president, Dr. Alain Beaudet gave a welcome speech to the DSEN established CCs and expressed his enthusiasm and confidence that DSEN researchers would be able to meet the expectations of the DSEN initiative. He also emphasized the leadership that the DSEN program was providing with respect to improving the accountability and targeting of research to meet CIHR's mandate.

AM session Outcomes

There was an overall collaborative spirit among DSEN investigators. Presentations by CCs representatives generated interest and discussions around methodologies and data access that could benefit DSEN research and allow the projects to be much more timely and efficient.

This network meeting was a first of a series of network meetings that DSEN is planning to take a leadership on in the future. This will allow DSEN CCs to continue discussions around best methods and potential areas of collaboration among their teams.

The PM session summary

This report summarizes the work generated by small groups working during the DSEN meeting to discuss how DSEN teams, CCs, associated programs and DSEN Coordinating Office can leverage expertise and collaborate across DSEN to stimulate the development of a National Curriculum on drug safety and effectiveness. The outcomes of group discussion are presented using the original wording generated by the groups so that the report can allow groups to continue discussions from the point the discussions ended. Therefore some of the statements may be less comprehensible to a reader who was not present for the group discussion

National Curriculum meeting outcomes

  1. Present an introduction to the National Curriculum
  2. Identify initial National Curriculum competencies and outcomes
  3. Identify initial National Curriculum priorities
  4. Discuss possible learning modalities
  5. Form a Working Group to carry on the work after this session
  6. Set expectations from the Working Group

The PM session agenda is contained in Appendix 2.
All participants were divided into small groups based on their team and CC affiliation. There were three small groups:

  • CNODES (1 pan-Canadian team)
  • Prospective studies (3 teams)
  • Network Meta-Analysis (3 teams)

Step 1: Generating Ideas

Each group had a discussion to answer the following question: What knowledge, skills and values/attitudes should a researcher in drug safety and effectiveness have to be successful?

The ideas generated by each group are listed below.

Small group: Network Meta-Analysis

  • Attitudes (engaging stakeholders, promoting collaboration and transdisciplinarity)
  • Policy maker doing "practicums" in research setting / practical exposure in rapid response units for policy makers
  • Regarding administrative databases: methodological issues (quality, linkages, coverage, missing data, clustering and confounding)
  • Caveat: selection of trainees or trainers and collaborators as knowledge and skills can be learned life-long but values and attitudes tend to be intrinsic and fairly constant over time
  • End of grant KT - skills to target citizens/patients, health care providers, and managers/policy makers
  • Knowledge and skills associated with nonrandomized studies
  • Integrated KT targeting different stakeholder groups
  • Statistical and epidemiological knowledge and skills: skills level could range from lower level awareness to expertise providing the ability to do oneself
  • Practicums for researchers making these decisions (local/prov/federal)
  • Research operations meaning research skills (operational) in grant writing, publishing, presentation skills, networking, mentoring
  • Reconciling collaboration and ethical behaviour when functioning in a competitive research environment
  • Knowledge about DRUGS (i.e. what is a receptor? How does the drug act in the body? Etc…)

Small Group: Prospective Studies

  • Thoughtfulness
  • Honesty
  • Pragmatism
  • Good communicator
  • Lifelong learner
  • Open-minded
  • Multidisciplinary (and interprofessionalism)
  • Clinical characterization of ADRs
  • ADRs: reporting, causality, signal detection and assessment
  • Coop opportunities with federal government, P/T governments, industry in pharm development
  • Risk management
  • Drug regulatory environment (Fed/Prov/Local)
  • Patient safety (clinical and basic science)
  • Pharmacology
  • Drug development process
  • Evidence-based medicine / evidence-based healthcare
  • Pharmaco-economics
  • Databases
  • Pharmacogenomics
  • Population health
  • Biostatistics/analytical methods
  • Epidemiology/pharmacoepidemiology
  • Clinical/comparative effectiveness

Small Group: CNODES

  • Understanding of both basic concepts in pharmacology and applications in clinical practice: i.e. what is a drug? How is it prescribed?
  • Knowledge: institutional understanding. History and mechanisms of regulation and the limitations and its effect on triggering decisions
  • Knowledge: understanding of barriers to getting knowledge used by clinicians and mechanisms for improving uptake
  • Skills; experience in applied settings ('on ice' experience)
  • Skills: ability to ask good questions and to operationalize them and to modify the question for the decision maker in certain contexts
  • Skill: database analysts need skill to train database analysts by distance; sharing tricks of the trade
  • Skills: ability to produce tools for evaluating competencies by distance
  • Professionalism
  • Confidentiality
  • Working in teams
  • Attitudes: absorbing attitudes by witnessing how to deal with conflicting values in implementing drug coverage decisions: real world multi criteria decision making
  • Attitudes: consideration of possible 'hidden curriculum' (resistance to evidence).

Step 2: Prioritizing Ideas

Each participant indicated their top priorities from the combination of the three lists generated above (using dots posted onto the post-it notes where each idea was written). The co-chair took the liberty of combining like items.

13 votes:

  • Biostatistics/analytical methods/Statistical and epidemiological knowledge and skills: can range from awareness to ability to do oneself (note listed twice)

11 votes

  • Knowledge about DRUGS (i.e. what is a receptor? How does the drug act in the body? Underlying physiology, molecular biology, genetics, genomics, Etc…) / Understanding of clinical practice basic concepts: i.e. what is a drug? How is it prescribed? [note listed twice]

9 votes

  • Policy maker doing "practicums" in research setting / Practical exposure in rapid response units for policy makers/ Practicums for researchers making these decisions (Local/Prov/Federal) [note: listed three times]

7 votes:

  • Professionalism
  • Confidentiality
  • Working in teams

6 votes:

  • Research operations meaning research skills (operational) in grant writing, publishing, presentation skills, networking, mentoring
  • Skills: ability to ask good questions and to operationalize them and to modify the question for the decision maker in certain contexts

5 votes:

  • Attitudes (engaging stakeholders, promoting collaboration and transdisciplinarity)
  • Reconciling collaboration and ethical behaviour when functioning in a competitive research environment
  • Open-minded
  • Multidisciplinarity
  • Administrative databases: methodological issues (quality, linkages, coverage, missing data, clustering and confounding (note listed twice)
  • Epidemiology/ pharmacoepidemiology

4 votes:

  • End of grant KT - skills to target citizens/patients, health care providers, and managers/policy makers
  • Integrate KT targeting different stakeholder groups
  • Skills; experience in applied settings ('on ice' experience)

3 votes:

  • Knowledge and skills associated with nonrandomized studies
  • Honesty
  • Clinical characterization of ADRs / ADR reporting causality, signal detection and assessment
  • Pharmacogenomics

2 votes:

  • Risk management
  • Pharmaco-economics
  • Population health
  • Clinical/comparative effectiveness
  • Attitudes: absorbing attitudes by witnessing how to deal with conflicting values in implementing drug coverage decisions: real world multi criteria decision making

1 vote:

  • Thoughtfulness
  • Pragmatism
  • Good communicator
  • Lifelong learner
  • Drug regulatory environment (Fed/Prov/Local)
  • Patient safety (clinical and basic science)
  • Pharmacology
  • Skills: ability to produce tools for evaluating competencies by distance
  • Knowledge: understanding of barriers to getting knowledge used by clinicians and mechanisms for improving uptake

Step 3: Initial ideas for learning experiences based on higher priority items

Each group spent time discussing the question: What types of learning experiences would best match various priorities identified? While considering the priority areas identified during the previous exercise. Each group was asked to report on their top three ideas that they would begin to work on.

Prospective studies:

  • Repetitive versus personalized activities: create short modular programs
  • Immersion experience is important
  • Values and attitudes require role modelling and experiences with multiple interactions

CNODES:

  • Figure out who are the trainees
  • Determine our goals: determine what is the end and always keep this in mind then work to that end; and for whom should the training be for? (e.g. if 10 observational studies need to be done in a year what are the training needs?)
  • Figure out what needs to be delivered and then deliver it
  • Collect lessons learned during each project and figure out how to transmit that around
  • The analysts across sites would benefit from training; some sites need more analysts trained to meet DSEN objectives; ideally they would develop a system of training each other
  • Limited resources so need to be realistic about what can be accomplished

NMA group:

  • Developed a 5x5 dimensional structure to use for curriculum development
  • METHOD of delivery:
    • individual-face to face
    • individual-distance learning
    • group-face-to-face
    • group – distance learning
    • practicum
  • CONTENT:
    • drugs and clinical context
    • epidemiology, statistics and administrative databases
    • research operations (grant writing, protocol development, publication, networking, etc.)
    • knowledge translation, and
    • health systems operations - regulations/reimbursement (product life-cycle)
  • LEVEL:
    • novice
    • advanced beginner
    • competent
    • proficient
    • expert

Step 4: Large Group Discussion on Next Steps

Discussion on what the next steps towards a National Curriculum should be was held as a large group. The main points of discussion are provided below:

  • Survey to all should be done to identify competencies for both completeness and acceptance if it is to be a National Curriculum
  • Work towards 2025: we are not cloning ourselves but rather trying to create a foundation that will work for the future
  • Other environments that are not DSEN can be tapped into such as ISPE
  • Start with the destination goals and work backwards
  • How to address credit for trainees for work done? University credit versus other types of credit?
  • Use of on-line course materials?
  • Extent of practical experiences needed? Consider coop?
  • Determine what resources are available
  • Develop both short term and longer term educational goals

Overall the meeting was able to meet four of 6 intended outcomes. The meeting did the following:

  1. Present an introduction to the National Curriculum
  2. Identify initial National Curriculum competencies and outcomes
  3. Identify initial National Curriculum priorities
  4. Discuss possible learning modalities

Some initial discussion was held regarding two of the outcomes listed below however these outcomes were not carried to completion.

  1. Form a Working Group to carry on the work after this session
  2. Set expectations from the Working Group

The reasons for this were that the planned activities made the afternoon quite busy, many participants had to leave by 4pm thereby reducing the available time for productive discussion, teams had not yet discussed their training plans as individual teams nor had they met as CCs and so it was ambitious to expect concrete plans established. The planning group felt that the meeting was very successful in initiating discussion about training, identifying and prioritizing some initial training areas, widening DSEN team member perspectives on different training modalities, and building collaborations across teams within CCs.

Acknowledgements

DSEN would like to acknowledge the participants for their contribution to make this first event of a series of network meetings successful. A special appreciation is extended to the CIHR President for his welcome speech and interest in congratulating new DSEN grantees.

Special Thank you! to the following planning committee members for this meeting:

  • Lisa Dolovich , McMaster University
  • Diane Forbes, DSEN-CIHR
  • Jean Gray, Dalhousie University
  • Stuart MacLeod, University of British Columbia
  • Robert Peterson, DSEN-CIHR
  • Siham Yasari, DSEN-CIHR

Appendix 1 – Meeting Agenda

8:00 – 8:30
Registration and breakfast

8:30 – 9:15

  • Welcoming and objectives of the day – Robert Peterson
  • Introductory session on DSEN Collaborating Centres and Research Agenda – Robert Peterson
    • Query Process and Feasibility Assessment
    • Review concept and structure of Science Advisory Committee (SAC)
    • Call for nomination for SAC
    • Granting steps process: explain project level funding

9:15 – 10:15

  • Team introductions/presentations
    • CNODES – David Henry / Colin Dormuth (20 mins)
    • CAN-AIM – Michal Abrahamowicz / Sasha Bernatsky (10 mins)
    • PREVENT – Colin Ross / Richard Kim (10 mins)
  • Question Session

10:15 – 10:30
Health Break

10:30 – 12:00

  • Team introductions/presentations (continued)
    • SEARCH – Ricardo Jimenez / Adrienne Borrie (10 mins)
    • KSRU – Sharon Straus / Joseph Beyene (10 mins)
    • NETMAN – Lise Bjerre (10 mins)
    • TNMA – George Wells (10 mins)
  • Question session

12:00 – 12:45
Lunch Break

12:45 – 13:00
Introduction to the National Curriculum

  • Robert Peterson (2 mins)
  • Lisa Dolovich (8 mins)
  • Stuart MacLeod (5 mins)

13:00 – 14:00
Identifying National Curriculum competencies and outcomes

  • Introduction – Lisa Dolovich (1-2 mins)
  • Small group activity (30 mins)
  • Report back to large group (15 mins)
  • Main large group discussion (15 mins)

14:00 – 14:15
Identifying initial National Curriculum priorities

14:15 – 14:30
Health Break

14:30 - 15:15
Examples of existing formal training opportunities

  • Malcolm Maclure (5 mins)
  • Sharon Straus (5 mins)
  • Ariel Arias (5 mins)
  • Lisa Dolovich (5 mins)
  • Joanne Kehoe (10 mins)
  • Colla Jean MacDonald (10 mins)

15:15 – 16:00
Initial ideas for learning experiences based on higher priority items

16:00 – 16:20
Next steps: National Curriculum Working Group

16:20 – 16:30
Closing remarks

  • Position of DSEN to help support the National Curriculum development – Robert Peterson
  • General thanks – Jean Gray and Lisa Dolovich

16:30
End of meeting


Appendix 2: PM Session Working Agenda

Chair: Jean Gray
Co-Chair and Facilitator: Lisa Dolovich

12:45 Introduction to the National Curriculum (15 mins)

  • Welcome and DSEN support for a National Curriculum – Robert Peterson (2 mins)
  • Context and Purpose for this meeting – Lisa Dolovich (8 mins)
  • Highlights of work done by Stuart, Judy, and Matt – Stuart MacLeod (5 mins via teleconference)

13:00 Identifying National Curriculum competencies and outcomes

  • Introduce activity in large group and then break into three (or four) small discussion groups based on CC affiliation – Lisa Dolovich (2 mins)
  • Small group activity (30 mins)
  • Report back to large group (3 groups x 5 mins = 15 mins)

Main small group discussion question:

What knowledge, skills and values/attitudes should a researcher in drug safety and effectiveness have to be successful? [related question to consider: What are the ideal characteristics of a DS&E researcher] (30 mins)

Each group will be encouraged to think about their specific DSEN focus AS WELL as more broadly beyond their specific DSEN focus so as to generate a wider pool of concepts.
Consider outcomes of learning at two levels:

  1. Trainee/junior researcher
    Timeframe: 2-3 years part time training
    Level of trainee: graduate, post graduate, junior researcher bridging to learn about a new area
  1. Lifelong learning
    Timeframe: many years of part time training
    Level of trainee: junior or seasoned researcher

Each small group will appoint a facilitator who will encourage discussion, input from all members, and time management. Each group will also appoint a reporter who will provide the report back to the larger group (and therefore have to read everyone else's handwriting!). Each person in the group will receive a few large post-it notes. As the discussion unfolds each person will take a turn writing up a specific competency under discussion onto a post-it note recording two things on each large post it note: (1) the knowledge/skill/value/attitude and (2) the desired outcome for the learner (if applicable this might be at two levels: junior/seasoned). As post-it notes are completed they will be posted to a nearby wall (if in a breakout room these will be brought back to the main room at the end).

Each group will report the competencies identified back to larger group.

Main large group discussion questions: (15 mins)

  1. How complete do we feel this list is?
  2. Do we feel it would be helpful to do a wider survey to identify a broader list?

14:00 Identifying initial National Curriculum priorities (15 mins)
Dot-mocracy exercise (15 mins)
Everyone gets 5 dots of one colour that is the same for all groups. Each person will review all post-its from ALL groups and use their dots to provide their individual voting on what they think the highest priority curriculum competencies are.

Everyone also gets 5 dots that are a colour specific to their group. Each person will review the post-its from their group and use their dots to provide their individual voting on what they think the highest priority curriculum competencies are within the set that their group came up with.

People can place as many or as few dots as they like. People can place both colours on the same competency if they feel it is a high priority across and within groups.

14:15 BREAK (15 mins)

14:30 Presentation of examples of existing formal training opportunities (30 mins)

  • Malcolm Maclure (5 mins)
  • Ariel Arias – (5 mins)
  • Sharon Straus – (5 mins)
  • Lisa Dolovich – (5 mins)

15:00 Leveraging Information Technology

  • Using the CIHR Training Program in Bridging Scientific Domains for Drug Safety and Effectiveness as an Example: Joanne Kehoe (10 mins)
  • Examples from other programs: Colla Jean MacDonald (10 mins)

15:15 Initial ideas for learning experiences based on higher priority items (45 mins)
Continue back in same small groups. Choose new group facilitator and group reporter. Review group post-it notes and priority 'dots'.

Discuss some initial ideas for learning experiences based on higher priority items. Write all key points down on flip chart.

Main question for each group: What types of learning experiences would best match various priorities identified?

Generate a list of the top 3 areas of work to be done either within each team or within each CC (each group can decide if they want to create this list per team or for the CC as a whole).

Report back to the rest of the audience on group perspective.

If the group is stuck here are some possible areas for discussion:

  • How would trainee assessment be carried out?
  • How to maximize distance learning technology?
  • When would face-to-face experience best?
  • What types of learning experiences would be fun for on-site / off-site faculty to participate in?
  • What types of learning experiences would be fun for on-site / off-site trainees to participate in?

16:00 Next Steps: National Curriculum Working Group (20 mins)
Large group discussion of the following:

  • Reflection on the need for a collaborative effort
  • Gaps of areas not covered by participants today
  • Areas of opportunity that could be leveraged not already mentioned today
  • Call for nominations to a National Curriculum Working Group (DSEN as secretariat?)
  • Define concrete actionable next steps for the Working Group

16:20 Closing remarks (10 mins)

  • Position of DSEN to help support the National Curriculum development (Robert Peterson)
  • General thanks (Jean Gray and Lisa Dolovich)

16:30 End of meeting

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