Event Details

Overview

This upcoming webinar will discuss the complexities and opportunities of clinical trials with hierarchical composite endpoints, covering topics such as win odds, win ratio, net benefit as well as regulatory considerations when defining hierarchical composite endpoints. We'll start this webinar with a general introduction to hierarchical composite endpoints and an overview of common analysis methods including win ratio, win odds, and net benefit. Then, the practical considerations will be illustrated through case studies from clinical trials in heart failure and chronic kidney disease. We conclude with a discussion and a Q&A. Join us to gain valuable insights and a comprehensive understanding of this topic.


Gotta Catch 'Em All – How to Capture All That Matters in Chronic Kidney Disease Trials? - Patrick Schloemer (Bayer AG)

Clinical trials in chronic kidney disease (CKD) often utilize composite endpoints comprising clinical events such as onset of dialysis or kidney transplantation along with a sustained large (e.g., ≥57%) decrease in glomerular filtration rate (GFR). Such events typically occur late in the disease course, resulting in large and long trials in which most participants do not contribute events. More recently, the rate of GFR decline over time (i.e. GFR slope) has been suggested as a more efficient endpoint, which is considered particularly useful in early CKD stages as well as patient populations with slower CKD progression.

This talk will present the use of hierarchical composite endpoints (HCEs) in clinical trials of CKD progression, emphasizing the ability to 'capture' all relevant information in a statistically elegant and clinically meaningful way. The application of this kidney HCE will be illustrated by post-hoc analyses of several large CKD trials.


Who is this event intended for? Statisticians with an interest in understanding the challenges and opportunities for hierarchical composite endpoints in drug development.

What is the benefit of attending? Learn about theory and application of hierarchical composite endpoints and their analysis methods (e.g., win ratio, win odds, net benefit) through presentations from statisticians in the industry and a regulatory discussant.


Timings

14:00-16:00 BST | 15:00-17:00 CEST | 09:00-11:00 ET

Tickets

PSI Member
Member Price Complimentary
PSI Non-Member
Standard Price Complimentary

Speakers

  • Patrick Schloemer (Principal Statistician at Bayer AG)

    Patrick Schloemer

    Principal Statistician at Bayer AG

    I am a Principal Statistician in late-stage cardiorenal development at Bayer AG, where I am currently acting as the Compound Statistician for the non-steroidal mineralocorticoid receptor antagonist finerenone and represent the statistical team on key internal and external committees to drive the strategic direction for the compound.

    I hold a Bachelor of Science degree in Mathematics from the University of Oldenburg and a Master of Science degree in Medical Biometry and Biostatistics from the University of Bremen. I earned my Ph.D. in Statistics from the University of Bremen in 2014 for my work on group sequential and adaptive designs for three-arm 'gold standard' non-inferiority trials.

    My methodological interests include adaptive designs, recurrent events, estimands and hierarchical composite endpoints. What I enjoy most about my work is presenting complex statistical concepts in a simple and entertaining manner, so that even non-statisticians can experience the joy of mathematics. I think this is an important prerequisite for the acceptance of novel statistical ideas by all stakeholders.

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Community

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