1. Beyond conventional RCTs: Exploring design options and modeling in drug development.
   Organizers: Marcia Rueckbeil, Els Goetghebeur, Mouna Akacha in collaboration with SiRA

   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.

2. STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative – recent progress and foci for the future
   Organizers: Willi Sauerbrei and Els Goetghebeur in collaboration with the STRATOS Steering Group

   The STRATOS (STRengthening Analytical Thinking for Observational Studies) initiative is a large collaboration of experts in many different areas of biostatistical research. It was launched at a halfday Mini-Symposium at ISCB 2013. The objective of STRATOS is to provide accessible and accurate guidance in the design and analysis of observational studies (www.stratos-initiative.org). We will present recent progress from some topic groups and discuss foci for the near future. Soon after the ISCB we will have our 3rd general meeting at the Lorentz Center in Leiden, Netherlands. Some of the talks look forward to cross topic groups research and include material from the preparation phase for this meeting.

Cost for those wishing to attend one of the two mini-symposia (please note that those registering to the conference can attend the mini-symposia without any additional cost – please select your preference when you register)