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Complex Clinical Trials – Driving Innovation
Session Chair(s)
Christine Fletcher, MSc
VP/Head, Speciality and Primary Care Statistics
GlaxoSmithKline, United Kingdom
Elke Stahl, PhD
Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Complex clinical trials embrace master protocols, platform, umbrella and basket designs and are used to improve decision making, increase speed of development whilst maintaining high quality in evidence generation by facilitating operational efficiency and patient allocation to the most promising treatment(s). Do you know what should be considered in the planning and setup of complex trials and what key stakeholders such as regulators and HTA assessors think of the evidence generated? What do patients think about these more complex clinical trials? Come to this session to find out!
Speaker(s)
CTFG Perspective
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
Industry Perspectives
Jens Leopold, DrSc
Bayer AG, Germany
Global Regulatory Leader
Regulatory and HTA Perspectives
Anja Schiel, PhD
Norwegian Medicines Agency (NoMA), Norway
Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA
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