Statistical Principles for Clinical Trials – ONLINE

Statistical Principles for Clinical Trials – ONLINE

  • 22/04/2022
    1:30 pm - 5:00 pm

Course details

statistics seminar | level: intermediate | register now
for questions related to this event, contact uantwerpen@flames-statistics.com
affiliation: University of Antwerp


Abstract

During this afternoon session the E9 Efficacy guideline ‘Statistical principles for Clinical Trials’ issued by ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) will be discussed. Important statistical principles necessary to take into consideration when designing, conducting and analysing your clinical trial will be reviewed. Topics covered are primary and secondary variables, blinding, randomisation, type of comparison (superiority, equivalence, non-inferiority), interim analysis and early stopping, data analysis considerations (e. g. analysis sets, subgroups). Special attention is given to different types of randomisation and group-sequential designs. Students are assumed to be familiar with basic principles of statistical testing.


Prerequisites


Background readings


Fee

PhDs and postdocs of a Flemish university: free
Other academics/Non-profit/Social sector: EUR 75
Private sector: EUR 200

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Venue

Online via Antwerp University


Instructor

Dr. Ella Roelant


During this afternoon session the E9 Efficacy guideline ‘Statistical principles for Clinical Trials’ issued by ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) will be discussed. Important statistical principles necessary to take into consideration when designing, conducting and analysing your clinical trial will be reviewed. Topics covered are primary and secondary variables, blinding, randomisation, type of comparison (superiority, equivalence, non-inferiority), interim analysis and early stopping, data analysis considerations (e. g. analysis sets, subgroups). Special attention is given to different types of randomisation and group-sequential designs. Students are assumed to be familiar with basic principles of statistical testing.

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