4th semi-annual Drug Safety and Effectiveness Network Meeting

Reporting results to the regulator: right format, right time, right target

1600, Scott Street, Holland Cross, Tower B, 2nd floor, Boardroom 2048, Ottawa, Ontario

Meeting report

March 22nd, 2013, Ottawa

Table of contents


Background

The Drug Safety and Effectiveness Network (DSEN) convened its fourth semi-annual Network meeting on March 22nd, 2013 in Ottawa to bring DSEN funded researchers together with decision makers working within the Federal Regulator; Federal, Provincial or Territorial (F/P/T) drug plans; and, organizations mandated to support F/P/T decision making with respect to drugs (e.g. Health Technology Assessment Organizations), to gain common understanding on the evidence needs of the Regulatory process.

The principal objectives of this meeting were:

  • to engage Network members in discussion on the specific information needs of drug regulatory agencies;
  • to provide network-wide interactions between DSEN funded researchers and decision makers;
  • to update participants on recent developments and upcoming plans and activities; and
  • to support a culture of knowledge translation (KT) within the DSEN program.

In Canada and worldwide, more information is needed on the safety and effectiveness of drugs used by diverse patient populations in real-world settings, outside the controlled experimental environment of clinical trials. DSEN has been established at CIHR in collaboration with Health Canada, and together with stakeholders from across Canada DSEN is looking to increase the evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients; and to increase capacity within Canada to undertake high-quality post-market research in this area.

In the context of DSEN, Health Canada's roles are operationalized by the Strategic Policy Branch (SPB) and the Health Products and Food Branch (HPFB). SPB provides corporate policy stewardship and coordination among DSEN program partners. HPFB provides regulatory oversight for the market authorization and surveillance of health products, and makes regulatory decisions based on an assessment of all the available evidence. For HPFB, evidence from DSEN is one of many sources which contribute to the ongoing assessment of drug safety and effectiveness, throughout the product life-cycle, as well as to the development of policies, guidelines and practices.

Health Canada's working environment also has restrictions and limitations which create specific complexities in terms of their access to, use and dissemination of research findings.

Thus, a thorough knowledge of how are determined DSEN Queries and what is needed in terms of research results reporting is a pivotal component the DSEN’s KT mandate.

Meeting summary

This 4th semi-annual meeting held by DSEN on March 22nd, 2013 at Health Canada’s premises was attended by 48 participants from the research and the decision making arenas (Agenda is attached in appendix 1 and Attendees list in appendix 2).

Robert Peterson, the DSEN Executive Director, gave welcoming remarks and explained the objectives of the meeting. He then presented the DSEN Queries’ process flow and the status of different projects. He also highlighted a variety of activities under the DSEN umbrella. Finally, he updated the audience on the funding allocations to the Networks.

The morning session was devoted to DSEN funded investigators to report on a single Query and provide updates on specific projects relevant to the decision makers present amongst the audience. Lunch time was allocated to keynote presentations by Gerald Dal Pan, Senior Official from the U.S. Food and Drug Administration (FDA) to share international insight and by Health Canada Senior Management staff Anne Lamar and Cindy Evans. In the afternoon, Diane Forbes, DSEN Associate Director presented a summary of the KT workshop held in early March 2013 for DSEN investigators on results reporting. Thereafter, four representatives from HPFB gave Health Canada’s perspective of the program, explained their expectations from the DSEN researchers and expressed their openness to further collaborate with DSEN investigators to better serve the Query submission process. A panel discussion took place later in the afternoon and it was an opportunity to integrate expectations and research capacity in the discussion so researchers and decision makers have a better and clearer understanding of different steps of the process. Finally, DSEN Executive Director announced upcoming events where DSEN will be actively engaged and gave an update on funding opportunities. A tentative date for the next semi-annual network meeting was given before the meeting was adjourned.

The AM session

Sasha Bernatsky from the CAnadian Network for Advanced Interdisciplinary Methods (CAN-AIM) team gave an update on different queries and projects. The team uses a combined approach, with both clinical cohort data and administrative data and includes assessments of the questions, as raised by Health Canada and provincial decision-makers. Sasha Bernatsky also gave an update on KT activities, Website development, and future DSEN-related opportunities the team is and will be engaging in.

Shannon Kelly from the Canadian Collaboration for Drug Safety, Effectiveness and Network Meta-Analysis (ccNMA) presented the different research clusters of the team based on their expertise. She briefly presented different queries investigators are working on and gave their update status but put focus on the Query related to an anti-Parkinson’s drug and risk of stroke and cardiac complications. The update included previous safety issues originating from the FDA, Feasibility Assessment of the Query, refinement of the question in collaboration with decision makers who initially submitted the Query, research proposal and methods. She also informed the audience of identified strengths and weaknesses of the methods to respond to the Query. Shannon stressed the importance of the ongoing interaction with Health Canada to help provide answers to decision makers’ concerns in a timely fashion.

Samy Suissa on behalf of the Canadian Network for Observational Drug Effects Studies (CNODES) presented the network in its structure and research capacity across the country. He presented the Query on atypical antipsychotics and diabetic ketosis. He gave an overview about the study the team has conducted to answer this question and presented the methodology and timelines. He highlighted different media activities and KT engagement the team uses to communicate the findings of this study.

Sharon Straus from the Knowledge Synthesis Research Unit (KSRU) presented the Query on the safety, effectiveness and cost-effectiveness of long acting vs intermediate acting insulin vs other classes of anti-diabetic drugs in both type 1- and type 2-diabetes. She described the process from its early stages and expressed her appreciation of the liaison with question posers. She described the feasibility assessment, protocol development and evolvement of the procedure as interactions happen between knowledge creators and decision makers.

Brian Hutton, on behalf of the NETwork Meta-Analysis (NETMAN) highlighted the structure of the team. He presented the Query on antidepressants, and risk of fracture and bone mineral density changes. He gave an overview of the protocol used in the study. Challenges faced were presented and suggestions to be taken into consideration for future queries were given. He also presented limitations of the available studies. Finally, Brian gave an overview of exciting news from the team and upcoming relevant activities.

Bruce Carleton presented on behalf of the Active Surveillance and Evaluation of Adverse Reactions in Canadian Healthcare (SEARCH). He reiterated the Query procedure and highlighted the interactions that take place throughout the process. He presented the Query on cardiac safety with antiemetics. The timelines from the Query receipt until the funding decisions are made were discussed in details. He also highlighted the challenges researchers face and made suggestions to how this could work better.

Richard Kim presented on behalf of the Pharmacogenomics and Adverse Reaction EVEnts Nation-wide Team (PREVENT). He stressed the importance of individual variability in drug response and in having serious consequences. He explained the DSEN Pharmacogenomic Biomarker Discovery Strategy and presented advances in genomics technology. Individual responses to drugs can be modulated by genetic variations and can lead to adverse reactions and lack of effectiveness. He explored the question regarding determining optimal treatment prior to therapy to prevent any additional risks and costs.

Keynote presentations

During lunch Time, Gerald Dal Pan, director of the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA gave a keynote address via videoconference. He shared an international insight on adverse event reporting. He explained the importance of epidemiological studies and clinical trials and the challenges faced with the use of each approach. He also highlighted main goals of Active Surveillance and differences against Passive Surveillance. He mentioned the study on how medicines are used and gave a brief description of the FDA Sentinel Initiative Pilots and the Mini-Sentinel program. He also provided examples of questions addressed, limitation, and how results are communicated once the studies are completed. Finally, Gerald Dal Pan shared his vision looking to the future and the importance of developing multiple sources of evidence and building epidemiologic capacity.

Anne Lamar, Associate ADM, HPFB, and Cindy Evans, Acting DG for the Marketed Health Products Directorate (MHPD), gave the HPFB senior management perspective on DSEN. An overview of health product surveillance and contribution of DSEN to this activity were presented. A current viewpoint on DSEN’s activities in providing data on real-world drug safety and effectiveness for the use of the decision maker was also presented. HPFB Senior Officials set the stage for the afternoon session by flagging the interest of HPFB in the success of DSEN, but also highlighting the need for more timely receipt of responses to queries, and pre-publication access to research results.

The PM session

After the Keynotes addresses and lunch, Diane Forbes gave a summary of the March 4th, KT Workshop on reporting research results and developing guidance and tools. The objectives were to identify standard principles for KT, establish KT milestones from a network perspective, and develop templates for reporting and disseminating of research results.

Jenna Griffiths from MHPD presented the Health Canada perspective on DSEN’s structure and value to Health Canada. She explained the representation of Health Canada (HC) within the DSEN governance structure and operational elements of the HC-DSEN team. She gave an overview of the current Query process and how it could continue to improve. Finally, she gave her vision on building on KT workshop guiding principles by defining timelines and time points for decision-making during the Query development and making study design and results transparent once available. She also suggested creating more opportunities for researchers to communicate their DSEN capacities to Health Canada.

Kelly Robinson from Therapeutic Products Directorate (TPD) gave an overview of TPD’s organizational structure, its function and business lines from pre-market Review, clinical trials testing and special access program. She presented uses of DSEN generated information (marketed drugs, ongoing clinical trials, classes of drugs, submission review and requirements). Finally, she shared experiences with DSEN and expectations for the future.

Co Pham, from MHPD gave a snapshot of the Canadian post-market surveillance program mandate, roles and activities and provided Health Canada’s perspective on the collaborative work with DSEN. To do so, he went over MHPD’s mandate and mission. He stressed the importance of maintaining and enhancing Canada Vigilance Program for collecting, processing and assessing adverse reaction and medication incident information. He also explained the post-market surveillance components and major activities and the importance of moving from passive to pro-active. He explained the perspective of Health Canada-DSEN collaboration and expectations from this program. Health Canada has a positive view of the DSEN program and its achievements that are useful for investigating safety issues, non-industry funded, Canadian-based, real-world data, forward/pro-active position and that Health Canada collaboration and interaction with DSEN is very welcomed. He also projected to continue to harness the collaborative spirit of DSEN, to increase the opportunity to respond to data gaps via DSEN and to fully integrate the DSEN track into HC safety evaluation with a decision-maker focus.

Barbara Njie from the Office of Paediatric Initiatives presented their mandate and went over the reasons why addressing food and drugs issues in children is important. She discussed a Query generated in the very early stage of DSEN (August 2009) and expressed her satisfaction with the quality of work that DSEN investigators were able to accomplish in response to this Query. Finally she made recommendations based on their office priorities and expressed her concerns regarding the long term impact of drugs on growth, development, epigenetics, etc. which is quite unique to the pediatric population.

Panel discussion

A panel discussion took place after the individual presentations from Health Canada representatives. The main objective was to clarify Health Canada expectations and DSEN researchers’ capacity and how to bridge the two elements to better serve DSEN mandate in addressing decision makers’ concerns in a timely fashion. Both parties were actively engaged and there seems to be a mutual understanding. Interactions will continue throughout the whole process.

Closing remarks

Robert Peterson adjourned this interesting integrated KT interaction. DSEN Coordinating Office will continue to offer assistance to both researchers and decision makers so they can interact with each other. Robert Peterson also announced the tentative date for the next semi-annual network meeting which is October 18, 2013.


Appendix 1 – Meeting agenda

8:00 - Continental Breakfast (provided)

8:30 - Welcome and Introductory Remarks (Robert Peterson, DSEN, CIHR)

8:45 - DSEN Update (Robert Peterson, DSEN, CIHR)

9:00- DSEN Funded Teams Report on their Interactions with Query Submitter

10:30 - Break (15 min)

10:45 - Keynote speaker - an international experience (Gerald Dal Pan, Director of Epidemiology and Surveillance, CDER, FDA)

12:15 - Keynote address (lunch provided) (Anne Lamar (Assoc ADM, HPFB) Cindy Evans (A-DG, MHPD, HPFB))

13:15 - Summary of DSEN KT Workshop (March 4th, 2013) on Results Reporting (Diane Forbes, DSEN, CIHR)

13:45 - Health Canada’s perspective and expectations (4 X 20 min) + Qs&As

  • HC DSEN Team (Jenna Griffiths, MHPD, HPFB)
  • Market Authorization (Kelly Robinson, TPD, HPFB)

14:30 - Break (15 min)

  • Post-Market Surveillance (Co Pham, MHPD, HPFB)
  • Drug Policy (Barbara Njie, PPIAD, HPFB)

15:45 - Panel Discussion Researchers and F/P/T Representatives (Moderated by R. Peterson, DSEN, CIHR)

16:15 - Closing Remarks (Robert Peterson, DSEN, CIHR)


Appendix 2 – List of attendees

Sasha Bernatsky
McGill University

Harold Boudreau
Health Canada

Christian Brochu
Canadian Institutes of Health Research

Matthew Brougham
Canadian Agency for Drugs and Technologies in Health

Suzanne Cadarette
University of Toronto

Chris Cameron
University of Ottawa

Bruce Carleton
University of British Columbia

Anne Champagne
Government of Saskatchewan

Laurie Chapman
Health Canada

Kristen Chelak
Canadian Agency for Drugs and Technologies in Health

Cindy Evans
Health Canada

Diane Forbes
Canadian Institutes of Health Research

Inna Gong
Western University

Jenna Griffiths
Health Canada

Frances Hall
Health Canada

Benji Heran
University of British Columbia

Melissa Hunt
Health Canada

Brian Hutton
University of Ottawa

Mike Innes
Canadian Agency for Drugs and Technologies in Health

Ricardo Jimenez
University of British Columbia

David Juurlink
Institute for Clinical Evaluative Sciences

Shannon Kelly
University of Ottawa

Richard Kim
University of Western Ontario

Anne Lamar
Health Canada

Jacques LeLorier
Université de Montreal

Linda Levesque
Queen's University

Robert Liteplo
Health Canada

Janice Ma
Health Canada

Sylvie Martin
Health Canada

Corine Mizrahi
McGill University

David Moher
University of Ottawa

Cristiano Moura
McGill University

Barbara Njie
Health Canada

Robert Peterson
Canadian Institutes of Health Research

Co Pham
Health Canada

Kelly Robinson
Health Canada

Colin Ross
University of British Columbia

Chander Sehgal
Canadian Agency for Drugs and Technologies in Health

Sumeet Singh
Canadian Agency for Drugs and Technologies in Health

Ingrid Sketris
Dalhousie University

Andrew Slot
Health Canada

Anne Smith
University of British Columbia

Sharon Straus
University of Toronto

Samy Suissa
McGill University

Yolaine Trottier
Health Canada

Jerieta Waltin James
Health Canada

Siham Yasari
Canadian Institutes of Health Research

My-Yen Yu
Health Canada

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