24 Mar Statistical Principles for Clinical Trials – ONLINE
- 22/04/2022
1:30 pm - 5:00 pm
Course details
statistics seminar | level: intermediate |
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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
Please register with the ticket in the category to which you belong. Applicable fees will be calculated after registration.
If your category is sold out, please register on the waiting list. Registration in another category will be invalid.
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.