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Session 6, Track B: Decentralized Clinical Trials
Session Chair(s)
Lorella Garofalo, PhD
Head of Regulatory Sciences
Pfizer Canada, Canada
Adoption of decentralized clinical trials (DCTs) has grown over the last few years spurred by the COVID-19 pandemic during which innovative trial operation strategies were needed to ensure that patients could continue to access new investigational treatments. DCTs have shown several advantages including improved patient engagement and outcomes as well as increased clinical trial diversity. While DCTs offer important opportunities to advance patient clinical trial experience and timely access to new therapies, challenges remain to ensure seamless trial execution with the right balance of traditional methods and technology in the best interest of patients. This session will review opportunities and challenges of DCTs from both an Industry and Regulator perspective.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize advantages and limitations of DCTs
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Discuss challenges in DCT implementation & possible solutions
- Define key GCP considerations for DCTs
Speaker(s)
Innovation and Decentralized Clinical Trials at Pfizer
Laurie Berry, DrSc
Pfizer, United States
Director of Strategic Partnerships
Health Canada’s Clinical Trial Compliance Program
Kevin Chin
Health Canada, Canada
Compliance Specialist
Health Canada’s Clinical Trial Compliance Program
Hocine Abid, MD, MBA
Health Canada, Canada
National Manager, Regulatory Operations and Enforcement Branch