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Joint meeting of the Royal Statistical Society
Edinburgh Local Group and Medical Section
Double Bill: Gordon Murray and Jim Slattery
8 February 2000
**2.30 pm** Please note time differs from that given in RSS
News
Room 301, Craighouse Campus, Napier University,
Edinburgh
Non RSS members are welcome to attend, particularly non-
statisticians interested in the issues. There is no need to book
a place but if you would like further information please contact
[log in to unmask], or phone 0131-455-2349.
Programme:
Jim Slattery, Medicines Control Agency
DESIGN OF TRIALS IN DIAGNOSTIC AGENTS
This talk will discuss current perceptions of how the
efficacy of diagnostic agents should be tested as reflected
in the guidelines being developed by regulatory authorities
in Europe and in the US. Some problems which have been
seen in recent application for licences to market such
products will be discussed and a current debate over the
evaluation of imaging techniques will presented.
Coffee/Tea
Gordon Murray University of Edinburgh Medical School
Improving the Design of Clinical Trials in Head Injury
In the last decade a number of "neuroprotective" agents have
been developed and taken forward into Phase III clinical
trials in severe head injury. This talk will review a number
of the controversial issues associated with these trials,
including interim analyses based on the idea of 'futility',
and the choice of appropriate outcome measures. The main
emphasis of the talk will be on strategies for targeting
patients for inclusion into trials (e.g. setting the
inclusion/exclusion criteria to reject patients with an
extreme prognosis), and how this impacts on the statistical
power.
Pamela Warner
Medical Statistics Unit
Department of Public Health Sciences
University of Edinburgh Medical School
Teviot Place
EDINBURGH EH8 9AG
Scotland UK
Ph.: 44-(0)131- 650 3248
Fax: 44-(0)131- 650 6909
email: [log in to unmask]
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