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