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Novel and Innovative Clinical Trial Designs: From Adaptive/Seamless Designs to the Trial of the Future

Track:
How Can We Enable Clinical Research in Europe Further?

Day & Time:
April 18, 4:00PM - 5:30PM (Central Europe Standard Time)

Session Number:
S0903

Room Number:
Boston 1-2

Level:
Advanced

Type:
Session

Title:
Novel and Innovative Clinical Trial Designs: From Adaptive/Seamless Designs to the Trial of the Future

Chair(s):
Mireille Muller, DrSc, PhD, MSc
Regulatory Policy Director
Novartis Pharma AG, Switzerland

Description:
Multiple trial design options are required to increase efficiency in clinical trial conduct in increasingly complex conditions and smaller populations while maintaining scientific value and data quality to meet the wants of all stakeholders.

Presentation(s) & Speaker(s):
Platform Trials
Michael Krams, DrMed
Vice President, Global Head Quantitative Sciences
Janssen Pharmaceuticals, Inc., United States

Regulatory and HTA Challenges with Innovative Clinical Trials
Sacha Wissink, PhD
Exec. Director Regulatory Affairs EMEA
MSD, Netherlands

Regulator’s Perspective: Master Protocols – Risks and Benefits
Benjamin Hofner, PhD
Biostatistician
Paul-Erhlich-Institut, Germany

Empowering Phase II Clinical Trials To Reduce Phase III Failures
Daniele De Martini, PhD
Associate Professor
Milano-Bicocca University, Italy