8:30-10:15 - Session 1: Clinical Trial Network Models

You may download the SPOR PowerPoint presentation [512k].
Other PowerPoint presentations in secured PDF format will be available for download after the Workshop.

Focus Questions: What is the 'scene' with respect to pediatric and perinatal clinical trials world-wide? What is Health Canada's position on pediatric therapeutics? What are the issues faced by national organizations that support clinical trials?

• EnprEMA (Anne Junker)
• GRIP (Shinya Ito, Hospital for Sick Children, Toronto)
• StaR Child Health (Hanneke van der Lee, Netherlands)
• USA Pediatric Clinical Trials Network (Jack Aranda, SUNY Downstate, NY)
• CIHR - SPOR (Philip Sherman, Alain Beaudet - CIHR)


Focus Questions: What works and what doesn't in doing Trials in Canada? What is the past, present and future for national networks and Trials?

• C17/Childhood Cancer (Kathy Brodeur-Robb, WCHRI, Edmonton)
• CAPRI/Rheumatology (Jaime Guzman, CFRI, Vancouver)
• PERC & PERN/Emergency Medicine (Martin Osmond, CHEO, Ottawa)
• Challenges in implementing perinatal clinical studies in Canada (William Fraser, Ste Justine, Montreal)
• The Clinical Support Unit (Colin Macarthur, Associate Chief Clinical Research, Hospital for Sick Children)


Focus Questions: What methodologies are required to study new interventions in children and pregnant women? How can we optimize experience with these methodologies for new and emerging investigators; and facilitate continuing professional development of experienced trialists?

• Methodological principles of trial design (Michele Hamm, University of Alberta, Edmonton)
• Community cluster randomization (Janusz Kaczorowski, Child & Family Research Institute, Vancouver)
• Pharmacogenomics Personalized Medicine (Evelyne Jacqz-Aigrain, France)


Focus Questions: Is there sufficient guidance for the conduct of perinatal and pediatric clinical trials provided by the Best Practices for Research in Children, and TCPS-2? New demands: DSMBs.

• Providing guidance on pediatric Issues: TCPS and Best Practices (Denise Avard, McGill)
• Providing guidance on obstetrical issues (Gideon Koren, Hospital for Sick Children, Toronto)
• Data & Safety Monitoring Boards: review of issues (Hanneke van der Lee, Netherlands)
• Data & Safety Monitoring Boards: the Vancouver experience (Ran Goldman, C&W)


• mHealth (Mark Ansermino)
• Administrative Health databases and Population Registries (Adrian Levy, Dalhousie)
• Trials in Ultra-Rare Diseases (Sylvia Stockler, Vancouver)