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Session 7: How Can Clinical Trial Innovative Designs Accelerate Medical Innovation for Patients?
Session Chair(s)
Sonia Viejobueno, LLM
US and Latin America Policy Lead, Global Regulatory Policy and Intelligence
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
FDA, United States
Division Director, Office of Biostatistics, CBER
Clinical Trial Innovative designs: Regulatory Agency Perspective
Laura Giselle Traversi, MD
ANMAT, Argentina
Head of Clinical Trials Department
Speaker
Gustavo Mendes Lima Santos, MPharm
Brazilian Health Regulatory Agency (ANVISA), Brazil
Herbal and Complementary Medicines Office - GMESP
Speaker
Telba Irony, PhD, MS, MSc
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences
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