> PSI Training Course: Equivalence and Non-inferiority Trials
>
> presented by
>
> Richard Kay
> Vice President, Biostatistics and Programming, PAREXEL
>
> 7th February 2000 (Course runs 0930 to 1700)
>
> This course will focus on the design and analysis of equivalence and non-inferiority trials in a clinical setting. It is therefore relevant to statisticians working in the
> later phases of clinical development who require an overview of the issues in terms of both design and analysis.
>
>
> Course Syllabus
>
> 1) Introduction
>
> - Superiority
> - Equivalence
> - Non-inferiority
> - 'Absence of evidence is not evidence of absence'
> - Some clinical background
>
> 2) Confidence Intervals for Establishing Equivalence and Non-inferiority
>
> - Method for equivalence
> - Equivalence testing is different
> - Two one-sided tests approach
> - Method for non-inferiority
>
> 3) The Choice of Equivalence Margins
>
>
> 4) The Choice of Control Group and Other Issues
>
> - Parallel group and cross-over trials
> - Lack of internal placebo control
> - The role of full-analysis and per-protocol sets
>
> 5) Sample Size Calculations
>
> - Comparing two means
> - Comparing a single mean to zero
> - Comparing two proportions
>
> 6) Other Issues
>
> - Regulatory Guidelines
>
> Each participant will receive course notes.
>
> Registration Costs:
> PSI Members: > £220.00 (plus £38.50 VAT)
> Non-Members: £245.00 (plus £42.88 VAT)
>
> Fee includes coffee, lunch and afternoon tea.
>
> Venue:
> The Bull Hotel, Oxford Road,
> Gerrards Cross, Bucks, SL9 7PA
>
> For further details contact:
> Tracey Hurst.
> PSI Executive Office
> Resources for Business
> South Park Road
> Macclesfield, SK11 6SH, UK
> Tel: +44 (0)1625 511750
> Fax: +44 (0)1625 267879
> E-mail: [log in to unmask]
>
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