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Methodologies Session
Session Chair(s)
Florian Lasch
Biostatistics Specialist, Data Analytics and Methods Task Force
European Medicines Agency, Netherlands
Elina Asikanius
Biostatistician
Finnish Medecines Agency Fimea, Finland
Exploring platform trials and the use of external controls in regulatory decision making, the methodologies session discusses innovative clinical trials designs and reflects on the regulatory acceptability in different situations. These topics will be complemented by a presentation on the structured harmonised protocol developed under ICH M11 and a discussion about it’s potential for facilitating deeper insight into the trial landscape and use of innovative design elements.
Learning Objective : This session aims to formulate the place of and solutions for setting up sustainable confirmatory (adaptive) platform trials for evaluation of multiple candidate interventions in the post-COVID era. The session will create awareness of the different stakeholders' perspectives on (adaptive) platform trials with the aim to stimulate interaction and collaboration.
Speaker(s)
Towards Sustainable Adaptive Platform Trials as a Source of Pivotal Evidence in the Post-COVID era.
Peter Van Ven, PhD
Dutch Medicines Evaluation Board (CBG-MEB) and University Medical Center Utrecht, Netherlands
Methodology assessor and Associate Professor in Clinical Trial Methodology
The Role of Externally Controlled (EC) Trials in Advancing Clinical Research and their Application in Regulatory Decision-Making
Katja Hakkarainen, DrMed, MPharm
Parexel International, Sweden
VP Epidemiology; Epidemiology & Real-World Science; RWE Scientific Affairs
Paving the Way for the Estimands Framework: ICH M11 Clinical Electronic Structured Harmonised Protocol
Noemie Manent, PharmD
European Medicines Agency, Netherlands
TDA-CTT Operations Workstream Lead
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