GPC – A novel statistical method for outcome analysis and reporting of prioritized composite endpoints

May 16, 2023

Join IDDI webinar to learn how the GPC method can be used to design clinical trials with multiple endpoints. You will also understand the differences between the GPC treatment effect measures: the net treatment benefit, success odds and win ratio.


Tuesday, May 16, 2023 | 5:00pm CET / 11:00am EST

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ABSTRACT:

In cardiovascular clinical trials, the primary endpoint often consists of multiple survival outcomes. These outcomes are commonly evaluated by a time-to-first event composite endpoint analysis. Novel statistical method for outcome analysis A time-to-first event analysis, however, has shortcomings in evaluating a treatment effect. It emphasizes each patient’s first event, which is often the outcome of lesser clinical importance. In addition, it ignores the severity of the events, ignores subsequent events in a patient, and clinically relevant non-survival outcomes cannot be considered. The generalized pairwise comparisons (GPC) method is an elegant statistical method for outcome analysis and reporting of prioritized composite endpoints in cardiovascular trials, as it allows flexibility in including all clinically meaningful outcomes in a single analysis. All clinically important outcomes, for example, bleeding severity, number of interventions, and patient reported outcomes, such as quality of life, can easily be implemented in a single analysis.

The treatment effect in a GPC analysis can be expressed in several measures, including the net treatment benefit, win ratio and success odds, but the win ratio has gained popularity in cardiovascular trials. These measures of treatment effect lead to equal p-values, but do not always provide the same insights into the clinical treatment effect.

In this webinar the available treatment effect estimates for GPC are reviewed, while pointing to the differences between these estimates, and suggesting recommendations for their implementation in clinical trials, in particular in the cardiovascular clinical area.

KEY TAKEAWAYS:

During this presentation, the participant will:

  • Understand the differences between the GPC treatment effect measures: the net treatment benefit, success odds and win ratio
  • Identify how the GPC method can be used to design clinical trials with multiple endpoints, in particular cardiovascular clinical trials
  • Gain insights in the interpretation of the GPC treatment effect measures

WHO SHOULD ATTEND?

Clinicians, in particular cardiologists, trialists, statisticians

WATCH RECORDED WEBINAR HERE

DOWNLOAD THE WEBINAR PRESENTATION HERE:

Mickaël De Backer, PhD Mickaël De Backer, PhD – Senior Research Biostatistician, IDDI
Mickaël De Backer holds a Master degree in Actuarial Sciences (ULB, 2014) and a PhD in Biostatistics (UCLouvain, 2018). After his PhD, he started working as a researcher on the statistical methodology called ‘Generalized Pairwise Comparisons’. He is now working on the same methodology as a Senior Research Biostatistician at the International Drug Development Institute (IDDI).

Mickaël De Backer, PhD Mickaël De Backer, PhD – Senior Research Biostatistician, IDDI
Mickaël De Backer holds a Master degree in Actuarial Sciences (ULB, 2014) and a PhD in Biostatistics (UCLouvain, 2018). After his PhD, he started working as a researcher on the statistical methodology called ‘Generalized Pairwise Comparisons’. He is now working on the same methodology as a Senior Research Biostatistician at the International Drug Development Institute (IDDI).

SPEAKERS:

Johan Verbeeck, PhD

Johan Verbeeck, PhD – Researcher-Expert, University of Hasselt 

Johan Verbeeck, PhD, holds a master’s degree in Biotechnology (2000) from the University of Ghent. After taking several medical positions in the pharmaceutical industry, in cardiology and rare diseases, he obtained a master’s degree in Biostatistics (2018) from the University of Hasselt, during which he received the Quetelet prize for an outstanding master thesis. He obtained a PhD in Biostatistics at the University of Hasselt (2022) on Generalized pairwise comparisons (GPC) and COVID-19. Currently he holds a researcher-expert position at the University of Hasselt, where his research continues to focus on statistical methods for multivariate outcomes, in particular the GPC method in cardiology and in small sample trials. Additionally, he is involved in several COVID-19 research and policy supporting projects, including COVID-19 in the workplace, vaccination, COVID-19 mortality and excess mortality. Verbeeck is involved in several H2020 funded innovation and demonstration projects on statistical methodologies to improve rare disease clinical trials. He acts as a consultant for clinical trials, mainly in the cardiovascular clinical area, jointly coordinated an EMA project evaluating the COVID-19 vaccines benefit-risk ratio and is a statistical editor for the European Heart Journal: Acute Cardiovascular Care. He is currently involved as a co-author in a book on GPC

 

Mickaël De Backer, PhD Mickaël De Backer, PhD – Senior Research Biostatistician, IDDI
Mickaël De Backer holds a Master degree in Actuarial Sciences (ULB, 2014) and a PhD in Biostatistics (UCLouvain, 2018). After his PhD, he started working as a researcher on the statistical methodology called ‘Generalized Pairwise Comparisons’. He is now working on the same methodology as a Senior Research Biostatistician at the International Drug Development Institute (IDDI).

Presentation Webinar: GPC – A novel statistical method for outcome analysis and reporting of prioritized composite endpoints

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