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Join Cytel for a webinar series that introduces biostatisticians and other members of the development team to some of the more commonly used complex innovative trial designs, the benefits of each, and the practical considerations for adoption. The series will include a stellar lineup of Cytel colleagues and partners including world renowned statisticians Nitin Patel, Cyrus Mehta, Zoran Antonijevic, Chris Jennison, Satrajit Roychoudhury, Thomas Burnett, Jose Pinheiro and more...

Series Schedule

  • Innovative Drug Development at a Glance - The Concepts, The Vision, & The Factors to Consider
    Complete - Click here to access replay
    Zoran Antonijevic, Head of Biometrics at MedSource
  • Group Sequential Designs and Sample Size Re-estimation – Modern Uses
    Complete - Click here to access replay
    Dr. Christopher Jennison, Professor of Statistics, University of Bath, UK
  • Practical Model-based Approaches for Phase I Oncology Trials
    Complete - Click here to access replay

    Dr. Satrajit Roychoudhury, Senior Director, Statistical Research and Data Science Center, Pfizer

  • Introduction to Population Enrichment Trial Designs
    Wednesday, July 15, 11AM EDT

    Dr. Thomas Burnett, Senior Research Associate in Medical and Pharmaceutical Statistics, Lancaster University

*Additional webinars in the series will be announced shortly.

Register

Complete the form and select the webinars you'd like to attend. If you are unavailable during the live webinar, please register and we will email you the webinar replay and slides directly.

Abstracts

Click here to learn more about the speakers.

Innovative Drug Development at a Glance - The Concepts, The Vision, & The Factors to Consider
Complete - Click here to access replay
Zoran Antonijevic, Head of Biometrics at MedSource

This webinar defines complex innovative trial design, briefly introduces the concepts, summarizes the potential benefits of each, and highlights key factors to consider when applying these techniques. With pharmaceutical and biotech companies under the pressure to deliver more and deliver faster with fewer resources, there is no time like the present to embark on this journey.

 

Group Sequential Designs and Sample Size Re-estimation – Modern Uses
Complete - Click here to access replay
Dr. Christopher Jennison, Professor of Statistics, University of Bath, UK

Group Sequential Designs were one of the earliest deviations from a traditional two-arm clinical trial with no interim looks at the data. They still add amazing value to trials through their abilities to safeguard patients, reach positive conclusions early, and keep trial designs simple and streamlined. Sample Size Re-estimation is another key tool in the modern trial designer’s toolkit. Learn the basics of these two methods, how they are used, and how they can improve trial design. 

 

Practical Model-based Approaches for Phase I Oncology Trials
Complete - Click here to access replay

Dr. Satrajit Roychoudhury, Senior Director, Statistical Research and Data Science Center, Pfizer

Phase I Oncology trials used dose-escalation to determine the maximum tolerated dose for further study. Modern model-based techniques help to acquire knowledge about the chemistry of the new drug and select appropriate dose for later phases. It offers clinicians more flexibility than more traditional designs like the 3+3. Through this introduction to advanced dose escalation methods, you will first learn about the traditional 3+3 method for dose-escalation and then gain an understanding of how Bayesian logistic regression model (BLRM) techniques can improve the traditional method. 


Introduction to Population Enrichment Trial Designs
Wednesday, July 15, 11AM EDT

Dr. Thomas Burnett, Senior Research Associate in Medical and Pharmaceutical Statistics, Lancaster University

Recent developments in genomics have made it possible to test how those with different biomarkers will respond to a new therapy or vaccine, optimizing using “enrichment strategies” and adaptive designs. This webinar will teach you the foundational elements of these designs, setting the stage for later webinars on basket, umbrella and MAMS designs.


 

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