A reminder that David Hand will give his talk on Datamining at 6pm on
Tuesday 11 January at Napier University, 10 Colinton Road, Edinburgh.
Non-members welcome.
There will be a joint meeting of the Edinburgh Local Group and Medical
Section on 8 February 2000 at 2.30 pm in Room 301, New Craig,
Craighouse Campus, Napier University, Edinburgh. (Please note change
of time and venue to that given in the January meetings card.)
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.
AND
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. None of the Phase III trials performed to date has shown
convincing evidence of efficacy in a broad population of head injured
patients, which is in marked contrast to the striking, robust evidence
of efficacy in the experimental models used in the pre-clinical
development of these compounds.
One possible explanation for this disparity is that there are
limitations inherent in the design of current Phase III trials in head
injury. This talk will review a number of the controversial issues,
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.
Non-members welcome.
Further information on either meeting may be obtained from Jill Sales
on 0131 455 2349 or e-mail [log in to unmask]
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