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Novel and Innovative Clinical Trial Designs: From Adaptive/Seamless Designs to the Trial of the Future
Session Chair(s)
Mireille Muller, DrSc, PhD, MSc
Regulatory Policy & Intelligence Director
Novartis Pharma AG, Switzerland
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.
Learning Objective : i) identify and discuss the problems, also ethical and economical, related to phase II planning; ii) evaluate if the techniques adopted for planning phase II are correct, in order to collect enough information to plan the subsequent, eventual, phase III; iii) influence the decisions about phase II planning.
Speaker(s)
Platform Trials
Michael Krams, MD
Janssen R&D, Johnson & Johnson, United States
Vice President, Global Head of Quantitative Sciences
Regulatory and HTA Challenges with Innovative Clinical Trials
Sacha Wissink, PhD
MSD Netherlands, Netherlands
Executive Director, Regulatory Affairs Europe
Regulator’s Perspective: Master Protocols – Risks and Benefits
Benjamin Hofner, PhD
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
Head of Data Science and Methods
Empowering Phase II Clinical Trials To Reduce Phase III Failures
Daniele De Martini, PhD
Milano-Bicocca University, Italy
Associate Professor
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