Event

PSI Conference Webinar: Impact of COVID-19 to estimands.

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Date: Thursday 11th June 2020

Time: 14:30 - 16:00
Chair: Chrissie Fletcher (GSK)
Speaker: Sue McKendrick (PPD), David Wright (AstraZeneca) & Kaspar Rufibach. 

Registration:

This webinar is part of our 2020 Conference Webinar Series. Further information including details of other webinars that are included in the Conference package can be found here.
Members receive all webinars in the conference series for free.
Non-members receive all webinars in the conference series for £100+VAT, which includes complimentary membership* of PSI until the 31st December 2020. 

To register your place for this event, and others in the Conference webinar series, please click here.

Session Abstract:

How can the Estimand Framework Help Us to Address Impacts of the COVID-19 Pandemic?
This webinar will focus on how the estimand framework can help us to pose and answer clinically relevant questions in the light of the COVID-19 pandemic.  It is important that we untangle the issues we face in our clinical trials if we are going to provide meaningful results and insights.
 
Our first example will set the scene as to why estimands are so important.  We will evaluate early published research into a potential COVID-19 treatment which received media attention. Although this work did not use the estimand framework, what would the estimand have been and what lessons can be learnt?
 
We will then consider impacts on ongoing case studies in chronic obstructive pulmonary disease (COPD)  and oncology.  The COVID 19 pandemic causes disruption of healthcare systems leading to inaccessibility of sites, treatment interruptions and discontinuations, missed or delayed visits, use of unexpected concomitant medications and deaths.  The scale of the impact will vary depending on our target population, therapeutic area and the timing of study recruitment relative to the course of the COVID-19 pandemic.  We will show how the estimand framework helps us to:
• revise the treatment effects of interest considering all five estimand attributes including accommodation of unexpected intercurrent events;
• propose sensitivity analyses to explore robustness of departures from assumptions (including missing data assumptions);
• propose supplementary analyses to more fully investigate and understand the trial data.  
 
Our case studies will illustrate how pre-specified estimands are impacted by the COVID-19 pandemic, and how methods for estimation including sensitivity analyses may need to be reconsidered to address missing data issues.  This session brings together colleagues from the EFPIA/EFSPI estimand implementation working group and the Estimands in Oncology ESIG.

Speaker Details:


Chair Biography
ChriFletcropped
Chrissie Fletcher
,
GSK
Chrissie has recently joined GSK as Vice President, Development Biostatistics. Prior to GSK, Chrissie worked at Amgen for 22+ years where she was the Biostatistics Therapeutic Area Head for Cardiovascular, Metabolic, Neuroscience, Nephrology and Inflammation. Chrissie has worked in the Pharmaceutical Industry for 29 years and she has experience of developing and commercialising new medicines in a variety of therapeutic areas across all phases of clinical development. Chrissie is actively engaged in Statistical societies (e.g. PSI, EFSPI), Pharmaceutical trade associations (e.g. EFPIA) andinitiatives relating to the Pharmaceutical Industry (e.g. ICH, IMI). In 2019 Chrissie was awarded PSI Honorary Member for her outstanding services to PSI, and she was an awardee of the Women in Data 2019 ‘Twenty Women in Data & Technology’ where she was recognised as an outstanding Women Leader.

Speaker

Biography

SueMcKencropped
Sue McKendrick,
PPD

Sue McKendrick is an Associate Statistical Science Director leading the cross-functional Estimand Working Group at PPD. She has an M.Sc. in Biometry 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.

DavWricropped
David Wright,
AstraZeneca

David became the Head of Statistical Innovation at AstraZeneca in September 2016. David leads a team of expert statistical methodologists who advise colleagues within AstraZeneca on novel trial designand analysis issues. Between 1999 and 2016 David worked for the Medicines and Healthcare products Regulatory Agency (MHRA) as a Statistical Assessor. David was heavily involved in the revision to the CHMP missing data guideline. He is currently involved in how the ICH E9 Addendum on Estimands impacts the design, analysis and reporting of clinical trials within AstraZeneca and is also a member of the EFPIA/EFSPI Estimand Implementation Working group.

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Kaspar Rufibach,
Roche

Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in-and externally, mentors students, and interacts with external partners in industry, regulators, and the academic community in various working groups and collaborations. He has co-founded and co-leads the European special interest group “Estimands in oncology” (sponsored by PSI and EFSPI, which also has the status as an ASA scientific working group, a subsection of the ASA biopharmaceutical section) that currently has 36 members representing 22 companies and several Health Authorities and works on various topics around estimands in oncology. Kaspar’s research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands and causal inference, estimation of treatment effects in subgroups,and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.

 

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