Workshop for micro-, small- and medium-sized enterprises: statistical perspectives in regulatory clinical development programmes

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Ημερομηνία

Παρασκευή, 5 Φεβρουάριος 2016, Ολοήμερο

Τοποθεσία

European Medicines Agency, Amsterdam, the Netherlands

This workshop aims to provide an introduction to general statistical considerations in clinical trials, and address statistical aspects of exploratory and confirmatory clinical trials.

Documents

Agenda - Workshop for Micro, Small and Medium-Sized Enterprises: statistical perspectives in regulatory clinical development programmes

Draft Reference Number: EMA/350683/2015

English (EN) (106.9 KB - PDF)

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Presentation - SME workshop: Session 1: Statistical common types of clinical trial design, study objectives, randomisation and blinding, hypothesis testing, p-values and confidence intervals, sample size calculation (Dav...

English (EN) (395.59 KB - PDF)

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Presentation - SME workshop: Session 2: Statistical considerations in exploratory studies (Byron Jones)

English (EN) (1.64 MB - PDF)

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Presentation - SME workshop: Session 3: Statistical considerations in confirmatory clinical trials I (Norbert Benda)

English (EN) (1.83 MB - PDF)

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Presentation - SME workshop: Session 4: Statistical considerations in confirmatory clinical trials II (Oliver Keene)

English (EN) (297.3 KB - PDF)

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