DSEN Collaborative Innovation Forum Report

Research Methodologies in Real World Drug Safety and Comparative Effectiveness

November 19, 2010
Ottawa, ON

Introduction

Recognizing the need for the Drug Safety and Effectiveness Network (DSEN) to support a multitude of research methodology platforms for the Network to be responsive to queries from decision makers, DSEN enlisted the collaboration of a number of stakeholders to participate in the planning of a Forum where a series of methods that are amenable to "real world" drug safety and effectiveness studies could be presented and discussed.

The aim of this Forum was to facilitate knowledge translation concerning DSEN applicable research methods and to create interactions between researchers, policy makers and industry in a neutral environment. It brought together stakeholders in the research community to:

  • discuss high quality research methods for the study of post-marketed drugs safety and effectiveness;
  • debate the merits and limitations of various methodological strategies responding to real world drug safety and comparative effectiveness issues; and
  • examine examples of successes, challenges, and best strategies.

The Forum was based upon the principle of "collaborative innovation" where the participants worked together in an open environment; freely sharing their expertise, experience, and recommendations.

Forum Summary

The Forum, held on November 19, 2010 in Ottawa, was well attended, with more than 75 participants from the Public (e.g., CIHR, Health Canada), Research, Information-Provider, Medical and Industry sectors from Canada and internationally. The Forum strategy was to have three parallel tracks where co-leaders, having a mix from both industry and academia, would discuss and debate the strengths, limitations, and methodology research needs, and subsequently provide advice to DSEN based upon these discussions.

The participants actively engaged in discussions regarding high quality research methodologies for the study of post-marketed drugs safety and effectiveness and examined the various elements in responding to "real world" drug safety and comparative effectiveness issues.

Attached to this report is a copy of the Forum Agenda (Appendix 1). The opening remarks were given by Dr. Ian Graham, Vice-President, Knowledge Translation and Public Outreach, CIHR followed by a presentation of the Forum's objectives and an overview of the DSEN by Dr. Robert Peterson, Executive Director, DSEN. The first portion of the morning session was dedicated to two keynote presentations by Dr. Paul C. Hébert, Editor-in-Chief, Canadian Medical Association Journal (CMAJ) and David K. Lee, Director, Office of Legislative and Regulatory Modernization, Health Canada.

Three parallel track sessions were run simultaneously during the remainder of the morning and the early afternoon along the methodological themes of:

Track 1: Network Meta-analysis / Systematic Reviews;
Track 2: Innovating Randomized Controlled Trials (RCTs);
Track 3: Observational Studies.

Following the afternoon break, participants reconvened in a final plenary session where Rapporteurs from each track provided a Track Report with highlights of the discussions, including recommendations for DSEN strategic investments.

Forum Outcomes

Copies of the Track Reports are reproduced in this report (Appendix 2).

These valuable contributions and expert advice will assist in guiding the direction of the DSEN as it progresses in generating knowledge that will contribute to evidence-based decisions on "real world" drug safety and effectiveness issues. Following the Forum, an on-line questionnaire was distributed to the participants to gain feedback for the planning of future similar events.

This Forum is the first of many collaborative networking and knowledge translation events that will be organized to actively engage various communities and facilitate DSEN in making available relevant knowledge and research evidence to decision makers and end users.

Acknowledgements

Appreciation is extended to the Program Planning Committee, Chairs, Rapporteurs, Speakers and Facilitators for a successful event in support of increasing evidence on drug safety and comparative effectiveness in a "real world" context.

The names of the Chairs, Rapporteurs, and Speakers can be found in Appendix 1.

The Planning Committee members were:

  • Tammy Clifford, CADTH
  • Graeme Fraser, BIOTECanada
  • Sarah Frise, AstraZeneca Canada
  • Tom Koutsavlis, Abbott Canada
  • Robert Peterson, Siham Yasari, and Gary Condran, DSEN, CIHR
  • Nigel Rawson, GlaxoSmithKline Canada
  • Duc Vu, Health Canada

The facilitators were:

  • Gary Condran, DSEN, CIHR
  • Robert Leitch, Health Canada
  • Fern Levine, Health Canada

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