SSA SA Branch October Meeting

SSA SOUTH AUSTRALIAN BRANCH OCTOBER MEETING
The South Australian Branch of the Statistical Society would like to invite you to the October meeting of the 2024 program. This is an online-only presentation regarding Estimands in Clinical Trials from Anneke Grobler & Francesca Orsini from the Murdoch Children’s Research Institute.

SPEAKERS

• Anneke Grobler is Team Leader at the Clinical Epidemiology & Biostatistics Unit. She has been involved in study design, manuscript writing, protocol writing, grant application, analysis of randomised clinical trials and epidemiological data and database set-up and management as well as the management of staff members.
• Francesca Orsini is Senior Biostatistician at the Clinical Epidemiology and Biostatistics Unit. She is involved in the design, planning, conduct, and statistical analysis of clinical trials in fields such as allergy, neonatology, and public health. She provides statistical consultancy, training in clinical research, and mentors students and team members. Her primary interest is in the design and analysis of clinical trials.

TOPICS

• Anneke Grobler: Introduction and overview of the Estimand Framework
• Francesca Orsini: BRACE - When COVID-19 specific vaccines became an intercurrent event

An estimand is defined as “the target of estimation to address the scientific question of interest posed by the trial objective”. An updated estimand framework was introduced to align objectives, trial conduct, statistical analysis, and interpretation in randomised clinical trials. The guidance provides five strategies to handle intercurrent events which occur after randomisation, such as discontinuation of treatment, use of rescue medication or death that may interfere with the estimation of treatment effects.

In this talk we will give a short introduction to the estimand framework, highlighting what is new. We will then illustrate the use of the estimand framework with a trial recently done in our unit. This was the BRACE trial, that was the winner of the 2024 ACTA STInG Excellence in Trial Statistics Award.