If you ask someone within the pharma world of statisticians on what is the hottest topic, you most likely will just get: Estimands!
Many scientific events, conference sessions, publications and presentations are organized around this topic. Thus, I’m super happy, that we have Mouna and Chrissie on the podcast as they have presented about this topic at various occasions.
In this episode, you will learn about
- the importance of the concept itself and it’s implications
- the terminology of the estimand framework
- and how it relates to missing data terminology
The episode covers the following questions and gives some examples on the different parts of the framework:
- What is the history of the estimands and how is it related to missing data?
- What is ICH E9 and why does it need an update now?
- What are the different parts of an estimand and how do they relate to each other?
- Is the estimand framework only applicable to clinical trials in the regulatory setting or is this something to be considered beyond the regulatory approval of new medications?
We also cover the PSI conference 2019, which surely will include sessions about estimands as well as the upcoming 1-day event organized by PSI: New Emerging Topics around Estimands and ICH Addendum. Click here to find more about this event and the registration page.
The ICH E9 (R1) addendum on estimands and sensitivity 5 analysis in clinical trials to the guideline on statistical 6 principles for clinical trials can be found here.
A nice interview with Mouna around estimands as well as a great list of resources was published by Cytel here.
About Mouna Akacha
Mouna Akacha is a consultant in the Statistical Methodology Group of Novartis Pharma AG, based in Basel, Switzerland.
In this role she provides internal advice for clinical projects across all development phases and therapeutic areas. One key aspect of her work is to make complex statistical problems and methods accessible to a wider audience. In addition, she is engaged in developing and implementing innovative statistical methods for clinical projects. Her role also includes training of internal statisticians and collaborations with external statistical centers and researchers.
Mouna has a wide range of research interests including topics on missing data, longitudinal data, recurrent event data and dose-finding studies. Before joining Novartis, Mouna studied mathematics at the University of Oldenburg in Germany and holds a PhD in statistics from the University of Warwick in the UK.
About Chrisse Fletcher
Chrissie is a Regional Head in Global Biostatistical Science at Amgen and she leads a Health Technology Assessment (HTA) Biostatistics group. Chrissie is also leading the development of Amgen policies and processes for sharing clinical trial data with external researchers. Chrissie has worked in the Pharmaceutical Industry for over 25 years and has experience of developing and commercialising new medicines from a variety of therapeutic areas across all phases of clinical development.
Chrissie is currently the Vice-President of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the EFSPI Communications Officer; a member of the Statisticians in the Pharmaceutical Industry (PSI)/EFSPI Regulatory Committee; chair of the PSI/EFSPI HTA Special Interest Group (SIG); member of the Integrated Data Analysis (IDA) SIG and member of the EFSPI data sharing working group. Chrissie is a member of the Clinical Development Expert Group for the European Federation of Pharmaceutical Industries and Associations (EFPIA), and she is one of 2 EFPIA representatives on the ICH E9 Revision 1 working group that is developing an addendum to E9 on estimands and sensitivity analyses. Chrissie is the Industry co-chair of the Innovative Medicines Initiative (IMI) ‘GetReal’ initiative Work Package 4 which is developing mathematical models and analytic tools for synthesising clinical evidence and predicting effectiveness of treatments based on data available from clinical trials and observational research databases/studies.
Chrissie is a Chartered Statistician and Chartered Scientist of the Royal Statistical Society (RSS). Chrissie has an MSc in Applied Statistics and a BSc (Hons) in Statistics with Management Science Techniques.