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Wednesday, June 19 • 4:30pm - 5:30pm
#377: Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-676-L04-P; CME 1.00; RN 1.00

This session will include a case study in a short-term depression trial with repeated measurements of continuous outcomes and two types of intercurrent events, and evaluate the four developed data-generating models. Can we jointly generate outcomes and intercurrent events that are associated for a generic phase 3 trial in simulation studies? What data-generating models can be used to achieve this?

Learning Objectives

Describe phase 3 randomized controlled trial data (clinical outcomes and intercurrent events) and model the association between efficacy outcomes and intercurrent events; Discuss how this research is needed to enable analytical or simulation studies that can investigate estimands and strategies on datasets generated under the same data-generating models; Identify how to implement the E9(R1) estimand framework.

Chair

Marian Mitroiu, PhD

Speaker

EMA Update
Francesco Pignatti, MD

MEB Update
Laura Rodwell, PhD


Speakers
avatar for Marian Mitroiu

Marian Mitroiu

Associate Director Biostatistics, Biogen, Switzerland
Marian is from Romania. In 2015-2016 he did a traineeship at EMA in London at the Biostatistics and Methodology Office. In 2017, he started his doctoral studies at Julius Center, UMC Utrecht and Utrecht University. He worked in parallel at CBG-MEB, being part of the Methodology Working... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Laura Rodwell

Laura Rodwell

Statistical Assessor, Dutch Medicines Evaluation Board, Netherlands
Laura has been working in research and biostatistics in one way or another for the past 20 years. After starting her career in crime research she became more interested in medical research and clinical trials. She completed her Master of Biostatistics in 2010 and a PhD in Biostatistics... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session