PSI TRAINING COURSE
GOOD STATISTICAL PRACTICE
Date 25th and 26th February 1999
Time 11.00 to 17.30 on Day 1 (registration from 10.30)
09.00 - 16.30 on Day 2
Location Taplow House Hotel, near Maidenhead, Berks
Course Fee PSI Members £550.00 (inc.£81.91 VAT @ 17.5%)
Non Members £575.00 (inc.£85.64 VAT @ 17.5%)
This two day course will address some of the practical issues that are
encountered in setting up and analysing clinical trials. It should be of
particular interest to statisticians who are relatively new to the
pharmaceutical industry. The course programme is attached.
The course will be presented by the following experienced statisticians from
within the industry.
Chrissy Fletcher (Amgen Ltd)
Debbie Hepworth (SmithKline Beecham Pharmaceuticals)
Mick Ireson (SmithKline Beecham Pharmaceuticals)
John Kirkpatrick (Insight Statistical Consulting Ltd)
Alan Phillips (Wyeth Research (UK) Ltd)
The course registration fee includes morning coffee, lunch, afternoon tea,
dinner and overnight accommodation (with en-suite facilities) on 25th
February plus breakfast, morning coffee, lunch and afternoon tea on 26th
February.
The closing date for registration is 29th January 1999.
Places are limited and can only be reserved on receipt of a completed
registration form.
Registration forms can be obtained from:
PSI Executive Office, Resources for Business, South Park Road, MACCLESFIELD,
Cheshire, SK11 6SH
Telephone +44 (0)1625 511750 Facsimile +44 (0)1625 267879
and should be returned by post or fax to the same address.
A confirmation letter, invoice and hotel details will be sent to each
delegate on receipt of the completed registration form. Payment should
follow by post as soon as possible.
COURSE PROGRAMME
The course will include presentations on the following topics/issues:
DAY ONE
Input To The Protocol
* Determining objectives and end-points
* Sample size calculations
* Randomisation
Populations
* Types of populations
* Definitions of populations
* Some of the more common problems encountered in defining populations
Interim Analysis
* Definition of an interim analysis
* Use of stopping rules and adjustment of p-values
* Breaking the blind
* Unplanned interim analyses
* Use of and interaction with Data Monitoring Committees
DAY TWO
Statistical Analysis
* Issues in multicentre trials
* Approaches to multiple end-points and time-points
* Consideration of missing values
* Superiority and non-inferiority in clinical trials
Efficacy and Safety Overviews
* Introduction to the regulatory process and documents
* Submission requirements
* Strategies for pooling studies
* Subgroups
* Safety updates and guidelines
For each of these sections either a practical or discussion session will be
included.
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