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Event Details

Overview

Randomised controlled trials (RCTs) have been the gold standard for the evaluation of efficacy and safety of medical interventions. However, investigators have incentives to look for alternative ways to obtain relevant comparative effect estimates more rapidly for healthcare decision makers. The EUnetHTA 21 methodological guidelines will be officially finalised late in 2024 and will impact the statistical approaches used to obtain these effect estimates. Indirect treatment comparisons (ITCs) for the joint clinical assessment (JCA) require the estimation of comparative effectiveness via non-randomised designs.


Statisticians must be prepared for the changes this guidance will require. Indirect treatment comparisons should be considered a fundamental tool in the pharmaceutical statistician's toolbox, alongside other commonly used statistical techniques in the industry.


This webinar aims to provide information on the purpose and methods for ITC. The speakers will review and compare different approaches for ITC in both anchored and unanchored case. Both drug regulatory and reimbursement body's views on using ITC will be discussed. The speakers will offer insights into issues such as marginal and conditional effect, unmeasured confounding and provide case studies to demonstrate the use of ITC methods in practice.


Who is this event intended for? Statisticians with an interest understanding indirect treatment comparison approaches.

What is the benefit of attending? To learn the latest developments in indirect treatment comparison methodology, regulatory and reimbursement body's view on using it and the relevant practical implication.


Dates & Times

  • Part 1 - Monday 26th February - 13:00-16:00 GMT (14:00-17:00 CET)
  • Part 2 - Monday 18th March - 13:00-16:00 GMT (14:00-17:00 CET)


Agenda

The event will be structured as two webinars, each of 3 hours. The first webinar will discuss ITC for an anchored case. The second webinar will discuss ITC for an unanchored case. You do not have to attend both webinars, but we highly recommend you join both webinars to have a comprehensive understand of the topic in ITC.


Day 1, 29th February 2024: Indirect treatment comparison for anchored setting

· Antonio Remiro-Azocar (Bayer) - Marginal versus conditional estimands, non-collapsibility and standardization in the context of indirect treatment comparisons

· Anja Schiel (Norwegian Medical Products Agency (NoMA) - ITC's applicability and acceptability in the European HTA landscape

· Suzy Van Sanden (Johnson & Johnson) - Matching-adjusted indirect comparison (MAIC): A case studies in prostate cancer

· Panel discussion


Day 2, 18th March 2024: Indirect treatment comparison for unanchored setting

· Kate Ren (University of Sheffield) - Unanchored indirect treatment comparison methods and unmeasured confounding

· Andrew Thomson (EMA) and Marcia Rückbeil(EMA) - The role of single-arm trials in the authorisation of new medicines

· Richard Sizelove (Eli Lilly) - Performance of MAIC for single-arm trials: a simulation study

· Panel discussion

Mar 18, 2024

1:00 PM - 4:00 PMGMT+0

Speakers

  • Min-Hua Jen (Senior Director of Eli Lilly & Company)

    Min-Hua Jen

    Senior Director of Eli Lilly & Company

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  • Antonio Remiro-Azocar (Lead Medical Affairs Statistician at Bayer PLC)

    Antonio Remiro-Azocar

    Lead Medical Affairs Statistician at Bayer PLC

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  • Anja Schiel (Special Adviser. Lead Methodologist in Regulatory and Pharmacoeconomic Statistics at Norwegian Medicines Agency)

    Anja Schiel

    Special Adviser. Lead Methodologist in Regulatory and Pharmacoeconomic Statistics at Norwegian Medicines Agency

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  • Suzy Van Sanden (Statistical Methods Lead HEMAR EMEA at Johnson & Johnson)

    Suzy Van Sanden

    Statistical Methods Lead HEMAR EMEA at Johnson & Johnson

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  • Kate Ren (Senior Research Fellow at School of Health and Related Research. The University of Sheffield)

    Kate Ren

    Senior Research Fellow at School of Health and Related Research. The University of Sheffield

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  • Andrew Thomson (Statisitician at European Medicines Agency)

    Andrew Thomson

    Statisitician at European Medicines Agency

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  • Marcia Rueckbeil (Biostatistician at European Medicines Agency)

    Marcia Rueckbeil

    Biostatistician at European Medicines Agency

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  • Richard Sizelove (Research Advisor at Eli Lilly & Company)

    Richard Sizelove

    Research Advisor at Eli Lilly & Company

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