Some places remain on this course. For further details or to register,
please contatct
Barbara Dodds
MPS Research Unit
The University of Reading
PO Box 240, Earley Gate
Reading RG6 6FN
Phone: +44 118 931 6662
Fax: +44 118 975 3169
E-mail: [log in to unmask]
Sample Size Determination in Efficacy and Equivalence
Trials
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22-23 February
2000
At the planning stage of a clinical trial a key question is 'How many
patients do we need?'” In efficacy studies we require sample sizes
that ensure sufficient statistical power to detect a difference of clinical
relevance between two treatments. In equivalence studies we require sample
sizes that establish with sufficient confidence that two treatments are
equally effective.
This course provides a general parametric approach to
sample size calculations applicable to patient responses which are binary,
ordinal, survival times or normally distributed. Comparisons are made with
other commonly used approximate and exact methods. Designs with multi-level
error structures such as cross-over and multi-centre studies, and with more
than two treatments are discussed. Practical aspects such as allowance for
drop outs, protocol violations and sample size reviews are addressed. The
course includes practical sessions involving the use of hand calculators.
Software packages for sample size calculations are discussed.
Programme
A general parametric approach to sample size calculations
Binary, ordinal, survival and normal data
Equivalence versus efficacy
Cross-over designs
Multi-centre studies
Designs with more than two treatments
Practical and ethical considerations
Software
Cost
500 pounds
(40% discount for public sector employees or full-time registered students)
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