DESIGN AND ANALYSIS OF CLINICAL TRIALS
13th - 15th September 2004
COURSE CONTENT
Basics of clinical trial design
- randomisation
- avoidance of bias
- ethical issues
Types of trial design
- parallel groups
- cross-over trials
- sequential metnods
Sample size
Explanatory vs pragmatic trials
Regulatory/organisational aspects
Analysis of parallel group studies
Cross-over trials
- design and analysis aspects
- two period trials
- multi-period trials
- N-of-1 trials
Trials for bioequivalence
Use of baseline values
Interpretation of results
- multiple testing
- subgroup analysis
- published papers
Introduction to unusual and advanced methods of design and analysis
THE SPEAKERS
The course will be given by staff from the Medical Statistics Unit of
The University of Edinburgh. Robin Prescott is Director of the Unit
and Professor of Health Technology Assessment. He has been working in
the medical field for over thirty years and has a particular interest
in cross-over trials. He has wide experience of multi-centre trials
and of working with the pharmaceutical industry. Gordon Murray is
Professor of Medical Statistics at The University of Edinburgh. He has
over twenty years of experience of collaborating in clinical trials
with medical colleagues, the pharmaceutical industry, and drug regulatory
authorities. Areas of particular interest include trials in
cardiovascular medicine and cliinical neurosciences.
WHO SHOULD ATTEND
This course is suitable for all clinicians and scientists involved in
the conduct of clinical trials, and for member of Ethics Committees.
In particular, Clinical Research Associates and Clinical Data Managers
will find this course extremely useful.
WHY ATTEND
A well-designed clinical trial, analysed competently, will enable
treatment evaluations to be made as precisely as possible while
minimising the chances of drawing the wrong conclusion. This course
will be practically orientated with lectures, practical exercises and
small group discussions interspersed throughout.
COURSE FEES
Standard rate £795
Academic institutions and registered charities £495
Fees include daily morning coffee, lunch, afternoon tea, a course
dinner and a delegate's pack including full course notes.
REGISTRATION AND FURTHER INFORMATION
To reserve your place(s), please complete the registration form on
the inside cover and fax or post it to:
Office of Lifelong Learning - CPD Unit
11 Buccleuch Place
Edinburgh EH8 9LW
Tel: 0131 651 1818
Fax: 0131 651 1746
Email: [log in to unmask]
Alternatively you can book online at:
www.lifelong.ed.ac.uk/cpd/courses
TERMS AND CONDITIONS
Payment should accompany your registration form. If invoiced, fees
must be paid in full by the day before the course is due to commence.
Failure to pay may result in attendance being refused.
For cancellations received in writing at least five working days
before the course commences, a 20% administrative charge will be made.
After this date, fees will not normally be refunded but places are fully
transferable.
The University of Edinburgh reserves the right to cancel or postpone the
course, in which case fees will be refunded in full. In the event of
cancellation, The University of Edinburgh will not be held liable for
registrants' travel or accommodation costs. All payments should be in
sterling. Please note that participants are responsible for payment of
any bank charges incurred.
VENUE
The course will take place in the Holiday Inn, Edinburgh-North, one
mile from the city centre and easily accessible from both the main
railway station and airport
ACCOMMODATION
Course participants have the opportunity to stay at the Holiday Inn,
Edinburgh-North at the reduced rate of £80 per night. All bedrooms in
the hotel have modem points. For further information please contact
Reservations on 0131 332 2442 quoting The University of Edinburgh.
Alternatively please contact our accommodation agency, Murray Accommodation.
Telephone: 08707 509808
Email: [log in to unmask]
or visit www.murray-accommodation.co.uk
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