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Session 4: Transforming Clinical Trial Design
Session Chair(s)
Maria Anillo
Regulatory Affairs Project Manager
AstraZeneca Canada Inc., Canada
A rapidly evolving clinical trial landscape has made changes to clinical trial regulations a goal for Health Canada. Ensuring that our regulatory framework can support innovative therapies as well as new clinical trial types and designs will enable clinical trials that best serve the needs of Canadians. This session will provide an overview and considerations for novel clinical trial design from the regulator and industry perspectives.
Learning Objective : - Describe the differences between adaptive designs, master protocols and decentralized trials, and how they have the potential to transform Canada’s clinical trial landscape
- Define the opportunities, challenges, and considerations for industry when applying novel techniques in clinical trials
- Define the impact and challenges that novel clinical trials designs may pose on regulators
Speaker(s)
Transforming Clinical Trial Design: Overview
Daniel L Keene, MD, MA, FRCPC
Health Canada, Canada
Associate Director, Office of Clinical Trials
Clinical Trial Design : Regulatory Challenges
Larissa M Lefebvre
Health Canada, Canada
Manager, Submission Management Division, OCT
Transforming Clinical Trial Design: Master Protocol Case Studies
Chantal MacDonald
Astrazeneca, Canada
Regulatory Affairs Project Manager
Adaptive Design Trials: Logistical Considerations for Clinical Operations
Vatche Bartekian, MSc
Vantage BioTrials, Canada
President