Date: 28 to 29 April (9:30 – 12:30 & 9:30 – 13:45)
Clinical trials aim to draw conclusions about the effects of treatments, but typically events after randomisation, such as treatment discontinuations or rescue medication usage, affect the interpretation of results. Different trial designs and analyses can then address different questions, such as does the treatment work when it is received as prescribed? or does the treatment work regardless of whether all is received? The answers to these questions may lead to different conclusions on treatment benefit.
To ensure trials address the clinical questions of interest, a new international drug trial guideline, the ICH-E9(R1) addendum, introduced the estimand framework to align planning, design, conduct, analysis and interpretation.
We are holding a meeting for clinicians and statisticians in clinical trials to discuss estimands and why they are important. This will be followed by an optional online workshop on how to implement the estimand framework on day 2.
Day 1 (28th April) is on ‘What are estimands and why should we be using them?’ and includes presentations from statisticians, clinicians and trial methodologists. Speakers and panelists include:
- Professor Amanda Adler (Director of Diabetes Trials Unit, University of Oxford)
- Dr Thinzar Min (Senior Clinical Lecturer, University of Swansea)
- Chrissie Fletcher (Vice President, Statistics, GSK)
- Dr Suzie Cro (Advanced Research Fellow and statistician, Imperial College London)
- Dr Brennan Kahan (Senior Research Fellow and statistician, MRC CTU @ UCL)
- Dr Victoria Cornelius (Reader in Medical Statistics, Imperial College London)
The optional follow-on workshop on day 2 is on ‘How to implement the estimand framework’ and will include presentations from statisticians, break out group practical sessions and panel discussions, additionally including:
- Professor James Carpenter (Professor of Medical Statistics, MRC CTU @ UCL)
- Professor Ian White (Professor of Statistical Methods for Medicine, MRC CTU @ UCL)
- Dr Helle Lynggaard (Principal Statistician, Novo Nordisk) & Bryan Goldman (Principal Statistician, Novo Nordisk)
- Professor Richard Emsley (Professor of Medical Statistics and Trials Methodology, Kings College London)
- Dr Beatriz Goulao (Research fellow and statistician, University of Aberdeen)
Day 1 is open to all registrants whilst places on the day 2 workshop are limited and available on a first come first served basis with priority for UK clinical trial unit affiliation and in first instance up to 2 places per institution. Attendance on day 1 is required to attend day 2.
Download an overview of the programme and aims for each day here
These events are free to attend and funded by the MRC NIHR Trials Methodology Research Partnership.