DIA EUROPE 2018

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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

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

Associate Professor

Milano-Bicocca University, Italy

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