Original Webinar Date: January 10, 2019
Abstract: Defining the estimand of interest in a clinical trial is crucial to align its planning, design, conduct, analysis, and interpretation. The need for more precise specifications of estimands was highlighted by the Steering Committee of the International Council for Harmonization (ICH) in 2014, which endorsed a Concept Paper with the goal of developing a new regulatory guidance, suggested to be an addendum to ICH guideline E9. The estimand discussions have highlighted that some established paradigms in the pharmaceutical industry, may need to be adapted and expanded in line with the scientific questions that are of interest to patients, prescribers, regulators, payers, and the sponsors. We will use NASH as example to illustrate the benefits of the estimand framework in facilitating the specification of the scientific question. We will also discuss the potential implications on study design, conduct and statistical analyses.
Presenters:
Abstract: Defining the estimand of interest in a clinical trial is crucial to align its planning, design, conduct, analysis, and interpretation. The need for more precise specifications of estimands was highlighted by the Steering Committee of the International Council for Harmonization (ICH) in 2014, which endorsed a Concept Paper with the goal of developing a new regulatory guidance, suggested to be an addendum to ICH guideline E9. The estimand discussions have highlighted that some established paradigms in the pharmaceutical industry, may need to be adapted and expanded in line with the scientific questions that are of interest to patients, prescribers, regulators, payers, and the sponsors. We will use NASH as example to illustrate the benefits of the estimand framework in facilitating the specification of the scientific question. We will also discuss the potential implications on study design, conduct and statistical analyses.
Presenters:
- Mouna Akacha, Novartis
- Jürgen Löffler, Novartis
- James Bell, Boehringer Ingelheim
- Santos Carvajal-Gonzalez, Pfizer
- Bettina Hansen, University of Toronto
- Elmer Schabel, BfArM & EMA
- Peter Mesenbrink, Novartis
- Presentation Slides (PDF)