On Demand Webinar Series:
Advancing Innovation in Clinical Trial Design
Evolution of Estimand framework and use in clinical trials
Cytel is excited to announce a new webinar series, Advancing Innovative Clinical Trial Design. Innovative trial design has provided pharmaceutical & biotech companies an opportunity to design and implement more efficient clinical trials in order to expedite the drug development process. Several regulators, including the FDA, EMA and CDE have encouraged the use of complex, adaptive, Bayesian and other novel clinical trial designs.
In this innovative webinar series, our industry leading speakers will discuss:
- Trends in clinical trial design
- Review the evolving landscape and statistical framework
- Discuss the use of various tools for optimizing trial designs and review the practical's when implementing trial simulations
- Present the use of Cytel’s East ® platform (the industry-standard software for adaptive clinical trial design and analysis) and Cytel’s Solara platform (the first trial strategy platform)
Watch the third webinar in the new series on demand, Adaptive design in early phase clinical trials. Estimands, Estimators, and Estimates: Aligning target of estimation, method of estimation, and sensitivity analysis, with application to the COVID-19 pandemic, led by Dr. Frank Bretz, & Dr. Jiawei Wei.
The ICH E9(R1) Addendum on 'Estimands and Sensitivity Analysis in Clinical Trials' introduced a framework to align planning, design, conduct, analysis, and interpretation of clinical trials. When defining the clinical question of interest, clarity is needed about 'intercurrent events' that affect either the interpretation or the existence of the measurements associated with the clinical question of interest, such as discontinuation of assigned treatment, use of an additional or alternative treatment and terminal events such as death. The description of an estimand should reflect the clinical question of interest in respect of these intercurrent events, and the Addendum introduces strategies to reflect different questions of interest that might be posed. The choice of strategies can influence how more conventional attributes of a trial are reflected when describing the clinical question, for example the treatments, population or the variable (endpoint) of interest.
During this presentation Dr. Frank Bretz & Dr. Jiawei Wei will:
- Motivate and introduce the ICH E9(R1) Addendum on estimands and sensitivity analysis in clinical trials to align planning, design, conduct, analysis, and interpretation of clinical trials.
- Discuss in detail intercurrent events that affect either the interpretation or the existence of the measurements associated with the clinical question of interest, such as discontinuation of assigned treatment, use of an additional or alternative treatment and terminal events such as death. Describe common strategies for addressing such events when defining the clinical question of interest.
- 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.