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Session 7: How Can Clinical Trial Innovative Designs Accelerate Medical Innovation for Patients?
Session Chair(s)
Sonia Viejobueno, LLM
Associate Director, Regulatory Policy LATAM, Johnson & Johnson Innovative Medicine, Argentina
Renata De Lima Soares
Regulation and Health Surveillance Specialist, Anvisa, Brazil
In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, designs such as master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple sub-studies, that may contain an adaptive design.
We will discuss Innovative Clinical Trials design, including Basket, Umbrella, Platform and Adaptive Clinical Trials and how they are contributing to accelerate patient access to new medicines and improve the efficiency and the success rate of clinical trials.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand basic concepts of Innovative Clinical Trials Design and their importance for current drug development
- Obtain greater understanding of Innovative Clinical Trials Design and how can industry and regulators across Latin America collaborate to support their implementation in the region
Speaker(s)
John Scott, PHD, MA
Division Director, Office of Biostatistics, CBER, FDA, United States
Laura Traversi, MD
Head of Clinical Trials Department, ANMAT Ministry of Health, Argentina
Clinical Trial Innovative designs: Regulatory Agency Perspective
Gustavo Mendes Lima Santos, MPHARM
Herbal and Complementary Medicines Office - GMESP, Brazilian Health Regulatory Agency (ANVISA), Brazil
Speaker
Telba Irony, PHD, MS, MSC
Senior Scientific Director, Quantitative Sciences, Janssen R&D, United States
Speaker
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