Novel and Innovative Clinical Trial Designs: From Adaptive/Seamless Designs to the Trial of the Future
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.
Platform Trials: Michael Krams, MD
Vice President, Global Head of Quantitative Sciences
Janssen R&D, Johnson & Johnson, United States
Regulatory and HTA Challenges with Innovative Clinical Trials: Sacha Wissink, PhD
Executive Director, Regulatory Affairs Europe
MSD Netherlands, Netherlands
Regulator’s Perspective: Master Protocols – Risks and Benefits: Benjamin Hofner, PhD
Head of Data Science and Methods
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
Empowering Phase II Clinical Trials To Reduce Phase III Failures: Daniele De Martini, PhD
Milano-Bicocca University, Italy
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