BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Estimands Implementation Working Group &ndash\; Training Subtea m in Collaboration with Estimation TeamDate: Monday 23 November 2026Time:& nbsp\;15:00 - 14:30 GMTLocation: \;Online via ZoomWho Should Attend? E ssential viewing for statisticians\, with valuable insights for medical wr iters\, clinicians and regulators.Why Attend? To explore challenges in ali gning estimation approaches with the clinical question of interest\, which is a core component of the ICH E9(R1) estimand framework.What Will the We binar Cover? This webinar will focus on aligning estimation to estimands.& nbsp\; How do different strategies for handling intercurrent events and mi ssing data handling influence the choice of estimation method\, with illus tration using a case study.OverviewJames Bell and Sue McKendrick will pres ent on behalf of the Estimands Implementation Working Group\, sponsored by EFPIA and EFSPI\, and hosted by PSI. This event will focus on the estimat ion aspects of the estimand framework. Having clearly defined the clinical question of interest through the estimand\, it is equally important to en sure that the estimation approach is appropriately aligned with that quest ion. In particular\, how do different strategies for handling intercurrent events influence the choice of methods used to estimate the treatment eff ect?The webinar will explore the challenges that arise when data are missi ng\, particularly when missingness occurs disproportionately following tre atment discontinuation or other intercurrent events. We will consider how different intercurrent event handling strategies affect the analysis\, the assumptions required\, and ultimately the interpretation of the estimated treatment effect.The session will draw on insights from the work of EIWG estimation subteam\, including simulation-based investigations of estimati on methods under different intercurrent event strategies. Reference:Bell\, J.\, Drury\, T.\, Mutze\, T.\, Pipper\, C.B.\, Guizzaro\, L.\, Mitroiu\, M.\, Rantell\, K.R.\, Wolbers\, M.\, &\; Wright\, D. (2024). Estimation methods for estimands using the treatment policy strategy: a simulation s tudy based on the PIONEER 1 Trial. Pharmaceutical Statistics\, 24(2). http s://doi.org/10.1002/pst.2472RegistrationThis webinar is free to attend for PSI Members &\; Non-Members.To register for this event\, please \; click here.Speaker details.table img {\n width: 150px\;\n height: 22 5px\;\n object-fit: cover\;\n }\nSpeakerBiographyJames Bell\, Contract Methodology Statistician\, Elderbrook Solutions \;James is a contract methodology statistician working for Elderbrook Solutions and chairs the estimation subteam of the Estimands Implementation Working Group (EIWG). H is main areas of research are missing data handling\, estimands and holist ic approaches to clinical trial design. \;Sue McKendrick\, Statistical Science Director\, Biostatistics - PPD\, Thermo Fisher ScientificSue has over 30 years&rsquo\; experience of statistical consultancy across drug de velopment including collaborating with clinical colleagues on developing e stimands in protocols. Sue chairs the Training Subteam of EIWG. David Wrig ht\, Head of Statistical Innovation\, AstrazenecaDavid Wright is Head of S tatistical Innovation at AstraZeneca\, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory cli nical trials. An active member of EIWG.Judith Anzures-Cabrera\, \;Stat istical Science Lead\, AstellasJudith is Statistical Science Lead at Astel las and has been actively involved in shaping the Estimands Academy for Tr ial Teams webinar series. \; DTEND:20261123T163000Z DTSTAMP:20260825T165643Z DTSTART:20261123T150000Z LOCATION: SEQUENCE:0 SUMMARY:Aligning Estimation with the Clinical Question of Interest UID:RFCALITEM639232738032577593 X-ALT-DESC;FMTTYPE=text/html:

Estimands Implementation Working Gr oup &ndash\; Training Subteam in Collaboration with Estim ation Team

Date: Monday 23 November 2026Time: \;15:00 - 14:30 GMT
Location:< /strong> \;Online via Zoom

Who Should Attend? Essential viewing for statisticians\, with valuable insights for medical writers\, clinician s and regulators.

Why Attend? To explore challenges in aligning estimation approaches with the clinical question of interest\ , which is a core component of the ICH E9(R1) estimand framework.< /strong>

What Will the Webinar Cover? This webinar will focus on aligning estimation to estimands. \; Ho w do different strategies for handling intercurrent events and missing dat a handling influence the choice of estimation method\, with illustration u sing a case study.

Overview

James Bell and Sue McKendrick wi ll present on behalf of the Estimands Implementation Working Group\, spons ored by EFPIA and EFSPI\, and hosted by PSI.

This event will focus on the estimation aspects of the estimand framework. Having clearly defined the clinical question of interest through the estimand\, it is equ ally important to ensure that the estimation approach is appropriately ali gned with that question. In particular\, how do different strategies for h andling intercurrent events influence the choice of methods used to estima te the treatment effect?

The webinar will explore the challeng es that arise when data are missing\, particularly when missingness occurs disproportionately following treatment discontinuation or other intercurr ent events. We will consider how different intercurrent event handling str ategies affect the analysis\, the assumptions required\, and ultimately th e interpretation of the estimated treatment effect.

The sessio n will draw on insights from the work of EIWG estimation subteam\, includi ng simulation-based investigations of estimation methods under different i ntercurrent event strategies.

Reference:

Bell\, J.\, Dr ury\, T.\, Mutze\, T.\, Pipper\, C.B.\, Guizzaro\, L.\, Mitroiu\, M.\, Ran tell\, K.R.\, Wolbers\, M.\, &\; Wright\, D. (2024). Estimation met hods for estimands using the treatment policy strategy: a simulation study based on the PIONEER 1 Trial. Pharmaceutical Statistics\, 24 (2). htt ps://doi.org/10.1002/pst.2472

Registration

This webinar is free to attend for PSI Members &\; Non-Members.
To register for this event \, please \;click here.

Speaker details

Spea kerBiography

James Bell\, Contract Methodology Statistician\, Elderbrook Solutions

 \;

James is a contract methodology statistician working for Elderbrook Solutions and chairs the estimation subteam of the Estimands Implementatio n Working Group (EIWG). His main areas of research are missing data handli ng\, estimands and holistic approaches to clinical trial design.

&nb sp\;

Sue McKendrick\, Statistical Science Director\, Biostatisti cs - PPD\, Thermo Fisher Scientific

Sue has over 30 years&rsquo\; experience of statistical consultancy ac ross drug development including collaborating with clinical colleagues on developing estimands in protocols. Sue chairs the Training Subteam of EIWG .

David Wright_cropped

David Wright \, Head of Statistical Innovation\, Astrazeneca

David Wright is Head of Statisti cal Innovation at AstraZeneca\, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical t rials. An active member of EIWG.

Judith Anzures-Cabrera\, \;Statistical Science Lead\, Astell as

Judith is Statistical Scie nce Lead at Astellas and has been actively involved in shaping the Estimands Academy for Trial Teams webinar series.

 \;

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