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Canada Annual Meeting

Session 4: Transforming Clinical Trial Design

Session Chair(s)

Maria  Anillo

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


Daniel L Keene, MD, MA, FRCPC

Transforming Clinical Trial Design: Overview

Daniel L Keene, MD, MA, FRCPC

  • Associate Director, Office of Clinical Trials
  • Health Canada, Canada
Larissa M Lefebvre

Clinical Trial Design : Regulatory Challenges

Larissa M Lefebvre

  • Manager, Submission Management Division, OCT
  • Health Canada, Canada
Chantal  MacDonald

Transforming Clinical Trial Design: Master Protocol Case Studies

Chantal MacDonald

  • Regulatory Affairs Project Manager
  • Astrazeneca, Canada
Vatche  Bartekian, MSc

Adaptive Design Trials: Logistical Considerations for Clinical Operations

Vatche Bartekian, MSc

  • President
  • Vantage BioTrials, Canada