Sample Size Determination in Clinical Trials
10-11 March
Presenters Anne Whitehead and Patrick Kelly
Location Medical and Pharmaceutical Statistics Research Unit
The University of Reading, UK
Cost £600 (with discounts for early booking - see below)
At the planning stage of a clinical trial a key question is 'How many patients
do we need?' For a superiority trial the main objective is to provide evidence
of superior efficacy for the new therapy relative to the control. This requires
a sample size that ensures sufficient statistical power to detect a clinically
relevant improvement. Equivalence or non-inferiority trials require sample sizes
that establish with sufficient confidence that the new therapy is respectively
equivalent to or no worse than the control.
This course provides a framework for sample size determination in superiority,
non-inferiority and equivalence trials. It considers a general parametric
approach applicable to binary, ordinal, time to event or normally distributed
patient responses. Comparisons are made with other commonly used approximate and
exact methods. Both parallel group and cross-over designs are considered.
Extension to more than two treatments is also considered. Practical aspects such
as allowance for drop-outs, protocol violations and mid-trial sample size
reviews are addressed. The course includes practical sessions involving the use
of hand calculators and training in software packages such as nQuery Advisor?
and PASS?.
Programme
* A general parametric approach to sample size calculations
* Binary, ordinal, time to event and normally distributed data
* A unified approach to superiority, equivalence and
non-inferiority trials
* Parallel group and cross-over designs
* Designs with more than two treatments
* Practical and ethical considerations
* Software
Course fees
Students £360
Sponsors/Public
sector/academic £450
Other £510
For bookings made less than 6 weeks prior to commencement of the course the
fee is £600
The course fee includes all supporting documentation, refreshments and lunches.
Dinner is included on the first evening.
Cancellation
Registrations are transferable to another course or individual at any time,
otherwise cancelled course registration will incur the following charges:
11 - 20 days before the start of the course 50%
1 - 10 days before the start of the course 90%
course start date or later 100%.
We reserve the right to cancel any course without liability other than a refund
of the course fee.
For further information please contact
Barbara Dodds
MPS Research Unit
The University of Reading
PO Box 240, Earley Gate
Reading RG6 6FN, UK.
Tel: +44 118 378 6662
Fax: +44 118 975 3169
E-mail: [log in to unmask]
http://www.reading.ac.uk/mps
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