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Wednesday, June 22 • 1:45pm - 2:45pm
#345: Statistical Issues in Master Protocols: Beyond Type I Error and Concurrent Controls

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-631-L04-P ; CME 1.00; RN 1.00

Platform trials combine the advantages of multi-arm trials with the flexibility of classical drug development based on independent studies. We will highlight the main statistical issues and cover both the European regulatory and industry perspective.

Learning Objectives

Describe the main statistical challenges in platform trials; Discuss the role of clinical trial simulations when designing master protocols; Identify the key aspects when planning and analyzing platform trials.

Chair

Alex Sverdlov, PhD

Speaker

Master Protocols: Considerations from EU-PEARL and the European Regulatory Network
Benjamin Hofner, PhD

Challenges in the Execution of Platform Trials in the Pharmaceutical Industry and What we Have Learned from EU-PEARL and the COVID-19 Pandemic
Peter Mesenbrink, PhD

Academic Update
Martin Posch, PhD



Speakers
avatar for Benjamin Hofner

Benjamin Hofner

Head of Biostatistics, Paul-Ehrlich-Institut, Germany
Benjamin Hofner is Head of Section Biostatistics at the Paul-Ehrlich-Institut (PEI). In this role he is involved in the assessment of Marketing Authorisation Applications and Clinical Trial Applications and provides Scientific Advice to stakeholders. He is Additional Assessor at the... Read More →
avatar for Peter Mesenbrink

Peter Mesenbrink

Executive Director of Biostatistics, Novartis Pharmaceuticals Corporation, United States
Peter Mesenbrink, PhD is an Executive Director of Biostatistics at Novartis Pharmaceuticals Corporation in East Hanover, New Jersey. Peter received his BS in Mathematics from UVM in 1989 and a PhD in Statistics from NCSU in 1995. He joined Novartis in 1995 and is currently Therapeutic... Read More →
avatar for Martin Posch

Martin Posch

Professor, Medical University of Vienna, Austria
Martin Posch is professor for medical statistics at the Medical University of Vienna. From 2011-2012 he worked as statistical expert at the European Medicines Agency (London, UK) in the Human Medicines Development and Evaluation sector, where he contributed to guideline development... Read More →
avatar for Alex Sverdlov

Alex Sverdlov

Senior Director, Biostatistics, Novartis, United States
Alex Sverdlov has worked as a statistical scientist in the biopharmaceutical industry since 2007. He is currently neuroscience disease area lead statistician in early clinical development at Novartis. Alex has been involved in active research on adaptive designs for clinical trials... Read More →


Wednesday June 22, 2022 1:45pm - 2:45pm CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session