Thursday, July 25, 2024

11:00 AM - 12:40 PM

PARALLEL HALL 1 (Maurice Saltiel I & II Hall)

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Overview

Organisers: Marcia Rueckbeil (Amsterdam NL), Els Goetghebeur (Ghent BE), Mouna Akacha (Basel CH) | Ιn collaboration with the ISCB Statistics in Regulatory Affairs (SiRA) Subcommittee

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Details

This session will explore the changing landscape of study design options and modeling techniques in the field of drug development. While randomized controlled trials (RCTs) are considered the gold standard for establishing causal relationships and estimating treatment effects, alternative approaches have gained traction in recent years. This shift is also evident in the guidance provided by regulatory agencies such as the FDA and EMA, who have issued recommendations for externally controlled trials, single-arm trials and model-informed drug development. With invited speakers representing academia, industry, and regulatory bodies, this session aims to foster a dynamic discussion on the opportunities and challenges encountered in adopting novel study designs and modelling approaches in drug development.

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Chair