Date: Tuesday 2nd July 2024
Time: 14:00-15:30 BST | 15:00-16:30 CEST
Location: Online via Zoom
Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.
What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
|
Speaker |
Biography |
|
|
Rachid Abbas is a statistician in Roche's Product Development department since 2020. With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
|
|
|
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019. She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
|
|
|
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
|
