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> 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] > %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%