Event

PSI EIWG Webinar: Impact of estimands

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Date: Thursday 30th June 2022
Time: 15:00-17:00 BST | 16:00-18:00 CEST
Speakers

Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians, Medical Affairs, Medical Writers, Health Economists, Real World Evidence Researchers.
What is the benefit of attending? The targeted learning outcomes are as follows:

  • Change of mindset – how to engage the clinical and statistical viewpoints in a transparent manner to gain alignment on the question(s) of interest.
  • Considerations in implementing estimands in protocols
  • Considerations regarding external reporting and communications
  • How estimands may impact other areas of research such as real world evidence and network meta-analyses.

Registration

You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.

Overview

This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. Building on the concepts and case studies previously discussed and recognizing the benefits of following the estimand framework (ICH E9 (R1)), stakeholders will discuss how the Estimands framework has impacted their way of working. Topics covered will include how estimands have changed mindsets, impacted protocols, reporting and influenced far beyond clinical trials.

Topics of discussion will be raised at different points during the session and there will be time allowed to answer your questions, which can be posted via the chat.

*The Series so far...

As mentioned above, we have already run three previous webinars as The Estimands Academy for Trial Teams, so we've linked these below if you'd like to catch them on-demand prior to this session.
PIONEERing estimands in Clinical Research- January 2021
Estimands in Oncology - How and Why - June 2021
Estimands from trial planning to publication in medical journals: The ETHOS trial - November 2021

Speakers

All of our presenters are members of the EFPIA/EFSPI estimand implementation working group (EIWG).

Speaker

Biography

Sueedit
Sue McKendrick

Sue McKendrick is Statistical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991, she graduated with an M.Sc. in Biometry from University of Reading, UK and has been a Chartered Statistician since 1998. Sue has over 25 years’ experience of statistical consultancy across drug development in both CRO and pharma companies, including collaborating with clinical colleagues on protocol development.

Rikkeedit
Rikke Mette Agesen

Rikke Mette Agesen is a Senior International Medical Manager in Clinical Drug Development at Novo Nordisk. She graduated as a Medical Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke holds a PhD and a Postdoctoral position in Type 1 diabetes and hypoglycaemia. With a physician’s perspective Rikke represents Novo Nordisk in EIWG.

Pepaedit
Pepa Polavieja

Pepa Polavieja is a biostatistician in Real World Analytics and Access at Ely Lilly. She obtained her MSc IN biostatistics from the Complutense University of Madrid and has been working for the pharmaceutical industry since 1997. Pepa has worked across early and late stage and many therapeutic areas, performing varying roles in the Global Statistics and Sciences organization. Since 2015, she leads the cross-Industry TransCelerate workstream focused on developing a Common Statistical Analysis Plan template, highly connected with the Common Protocol Template, both including the estimands framework. She leads training and implementation activities through the estimands community at Lilly, and is a member of the EIWG.

Melanieedit
Melanie Wright

Melanie Wright is a Biostatistics Global Group Head at Novartis Pharma AG. She has an MSc in Biometry from University of Reading (UK) and started working in the pharmaceutical industry in 1996. Despite her background in statistics, Melanie describes herself as “an experienced drug developer with a focus on structured quantitative decision making”. Melanie leads the cross-functional estimands training at Novartis and is the lead of an EIWG sub-team concerned with transparency of reporting trial results.

Helleedit
Helle Lynggaard

Helle Lynggaard is a Principal Statistician in Data Science at Novo Nordisk. She obtained her MSc from the University of Aalborg in 1994 and her PhD in 2005 from the University of Copenhagen. She has worked with Novo Nordisk since 1994 in different statistical roles including being a Project Statistician. Since 2015 she has been working in a cross-project biostatistics department that provides support to statisticians in the clinical projects. Helle is a key driver in implementing estimands in Novo Nordisk studies and has been the driver for implementing the estimand framework in the TransCelerate Common Protocol and the Statistical Analysis Plan templates

 

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