Watch the webinars here

• Available On Demand: April 8th – Bayesian statistics with applications in clinical trials in the new era
  • Yuan Ji, Ph.D., Executive Advisor at Cytel and Professor of Biostatistics (with tenure) at The University of Chicago
    • During this webinar Yuan Ji will discuss: 
      • How Bayesian modeling can help mitigate the potential errors in decision making in early-phase expansion cohort trials. In late phase, due to current regulatory constraints, statistical errors are expressed in frequentist type I and type II error rates.
      • How Bayesian and frequentist sequential decision making are different, especially through interim analyses. Various Bayesian approaches will be presented.
• Available On Demand: April 22nd – Adaptive design in early phase clinical trials
  • James Matcham, Vice President Strategic Consulting at Cytel
  • This webinar will outline the trends in the use of adaptive design in early phase clinical trials. During the webinar James Matcham will discuss:
    • The use of Bayesian (and other) dose escalation designs
    • Early proof of concept designs
    • Designs with Combination products
    • Adaptive Dose finding designs
    • Population Enrichment designs
• Available On Demand: April 29th – Evolution of Estimand framework and use in clinical trials
  • Frank Bretz, Ph.D., Quantitative Scientist, Novartis & Jiawei Wei, Ph.D., Director Biostatistician in the Advanced Methodology and Data Science group at Novartis
  • During this presentation Dr. Frank Bretz & Dr. Jiawei Wei will:
    • Introduce the estimand framework according to the ICH E9(R1) Addendum and describe various strategies for addressing intercurrent events when defining the clinical question of interest
    • Discuss in detail the hypothetical estimand strategy, where a scenario is envisaged in which the intercurrent event would not occur. The Addendum acknowledges that a wide variety of hypothetical scenarios can be envisaged, but it also clarifies that some scenarios are likely to be of more clinical or regulatory interest than others.
    • Demonstrate how the estimand framework can usefully be applied to clinical trials impacted by the COVID-19 pandemic to address potential pandemic-related trial disruptions and embed them in the context of study objectives and design elements.
• Available On Demand: May 13th -Design for results: statistical software to optimize your clinical development strategy
  • Yannis Jemiai, Ph.D., Chief Scientific Officer at Cytel
  • In this webinar the Yannis Jemiai will discuss:
    • How quantitative sciences play a critical role in a product team’s ability to make optimal decisions earning the statistician a place at the strategic development table
    • How long-standing industry standard software East helps statisticians quickly and easily explore adaptation options for their study design
    • How Solara, a next-generation cloud-enabled SaaS platform, empowers statisticians and helps the wider product development team understand strategic priorities and trade-offs in the broader design space
• Available On Demand: May 27th – Introduction to Design and Monitoring of Adaptive Clinical Trials
  • Cyrus Mehta, Ph.D., President and co-founder of Cytel and Adjunct Professor of Biostatistics, Harvard University
  • In this webinar the Cyrus Mehta will discuss:
    • Point 1 Early stopping for efficacy or futility
    • Point 2 Mid-course correct to on-going trials
    • Point 3 Control of errors due to multiple testing
• Available On Demand: June 10th – Platform trials, Master protocols and the challenges in execution
  • Kyle Wathen, Ph.D., Vice President of Scientific Strategy and Innovation
• Available On Demand: June 17th -Embrace The Digital Era of Clinical Trials in China  – Challenges and Opportunities
  • Luyan Dai, Ph.D. Vice President of Strategy and Innovation, Chief Statistician at HLT

Meet the Speakers

• Yuan Ji, Ph.D., Professor of Biostatistics (with tenure) at The University of Chicago
• James Matcham, Vice President Strategic Consulting at Cytel
• Frank Bretz, Ph.D., Quantitative Scientist at Novartis
• Jiawei Wei, Ph.D., Director Biostatistician in the Advanced Methodology and Data Science group at Novartis
• Yannis Jemiai, Ph.D., Chief Scientific Officer at Cytel
• Cyrus Mehta, Ph.D., President and co-founder of Cytel and Adjunct Professor of Biostatistics, Harvard University
• Kyle Wathen, Ph.D., Vice President of Scientific Strategy and Innovation
• Luyan Dai, Ph.D. Vice President of Strategy and Innovation, Chief Statistician at HLT

Join to learn from leading experts as they explore potential scientific and operational implications—along with approaches to address potential challenges.