Defining research questions and improving clinical trial design: Introducing the estimand framework

Registration options

There are two registration options for this event. Please choose one ticket option only.

1. Morning and afternoon session | 9.30am – 4.00pm AEDT
2. Morning session only | 9.30am – 12.00pm AEDT

What are estimands and how can they help?

Trials in cancer have numerous challenges, such as worsening function, high mortality and treatment discontinuation. These post-randomisation events are particularly salient for patient-reported outcomes. Even with identical objectives, different trials produce variable results due to inconsistencies in how these events are handled. Appropriate reporting of treatment effects is critical for the translation of findings to practice and policy. There has been a new effort to align trial objectives, design and analysis, improve communication, and clarify interpretation of the effect of treatment known as the estimand framework. Estimands offer researchers the opportunity to address these well-known issues.

The workshop

This workshop will include morning and afternoon sessions on 8th February as follows:

• Morning session (via Zoom or in-person at UTS) 9.30-12.00pm - introduction to estimands, covering how to define and document trial estimands based on internationally agreed guidelines.
• Afternoon session (in-person at UTS only, with attendance at the morning session a requirement) 1.00pm-4.00pm - an opportunity to apply the estimand framework to example trials in hands-on exercises including those submitted by attendees ahead of the workshop (more details to follow after registration)

Presenters

Dr Jessica Roydhouse, Select Foundation Senior Research Fellow in Health Services Research, Menzies Institute for Medical Research, University of Tasmania Bio Link

Sabine Braat, Senior Research Fellow (Biostatistics), Melbourne School of Population and Global Health, The University of Melbourne Bio Link

Dr Anneke Grobler, Senior Research Fellow (Biostatistics), Clinical Epidemiology & Biostatistics (CEBU), Murdoch Children’s Research Institute Bio Link

Pre-reading

For an introduction to estimands and their application to a palliative care clinical trial, see the following recent articles by the workshop presenters:

Roydhouse J, Floden L, Braat S, Grobler A, Kochovska S, Currow DC, et al. Missing data in palliative care research: estimands and estimators. BMJ Supportive & Palliative Care. 2022:bmjspcare-2022-003553.

Grobler AC, Lee KJ, Wong A, Currow DC, Braat S. Handling missing data and drop out in hospice/palliative care trials through the estimand framework. Journal of Pain and Symptom Management. 2022:jpainsymman.2021.12.022

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