DSEN Collaborative Innovation Forum: Research Methodologies in Real World Drug Safety and Comparative Effectiveness

DSEN organized the first key collaborative innovation forum on Research Methodologies in Real World Drug Safety and Comparative Effectiveness held on November 19, 2010 in Ottawa. The Forum was well attended by more than 75 participants from the Public (e.g., CIHR, Health Canada), Research, Information-Provider, Medical and Industry sectors from Canada and internationally. The participants actively engaged in discussions regarding high quality research methodologies for the study of post-marketed drugs safety and effectiveness and examined examples of successes, challenges, and best strategies in responding to "real world" drug safety and comparative effectiveness issues.

Opening remarks were given by Ian Graham, Vice-President, Knowledge Translation and Public Outreach, CIHR followed by a presentation of the Forum's objectives and an overview of the Drug Safety and Effectiveness Network by Robert Peterson, DSEN Executive Director. The first portion of the morning session was dedicated to keynote presentations by Paul C. Hébert, CMAJ Editor-in-Chief and David K. Lee, Director, Office of Legislative and Regulatory Modernization, Health Canada.

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

• Track 1: Network Meta-analysis / Systematic Reviews led by George Wells (University of Ottawa Heart Institute) and Heather Bennett (I3 Innovus) with additional presentations by Christopher Cameron (CADTH);
• Track 2: Innovating Randomized Controlled Trials (RCTs) led by Robert Noble (GlaxoSmithKline) and José Pinheiro (Johnson & Johnson) with additional presentations by Robert Li (Health Canada), Jeff Maca (Novartis), and Michael Krams (Johnson & Johnson);
• Track 3: Observational Studies led by David Henry (ICES) and Jesse Berlin (Johnson & Johnson) with additional presentations by Jeff Brown (Harvard Medical School) and Muhammad Mamdani (St. Michael's Hospital).

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.

The DSEN Collaborative Innovation Forum Report provides further details on the Forum, includes the Forum agenda and informative reports from each of the three parallel tracks. Copies of a number of the Forum presentations are available upon request. If you have any questions or if you wish to obtain electronic copies of the Forum presentations, please contact us by e-mail at DSEN-RIEM@cihr-irsc.gc.ca

Opening Remarks, Ian Graham PhD, Vice-President, Knowledge Translation and Public Outreach, CIHR
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Welcoming, Forum Objectives and Overview of the DSEN, Robert Peterson, MD, PhD, MPH, Executive Director, DSEN, CIHR
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DSEN Collaborative Innovation Forum Report
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