THE CAMBRIDGE STATISTICS DISCUSSION GROUP
Thursday 9th May 2002 7:15 for 7:45
Strangeways Research Laboratory,
Worts Causeway,
Cambridge
Eleven years of statistics and statistical issues in the
pharmaceutical industry.
Kris Kelly,
Formerly Amgen Ltd.,
Cambridge
Abstract:
I was taught by my very old fashioned tutor that the three
important principles of biological experimentation are replication,
randomisation and restraint, the latter meaning control. I will deal with
control in its most general sense, focussing on issues for Randomised
Controlled Clinical Trials using examples from my 7 years in academia and
11 in the pharmaceutical industry. This will include control groups,
stratification, eligibility criteria and regulation including audit. I
will touch on the implications of the Declaration of Helsinki as amended
in 2000 and the International Conference on Harmonisation (ICH) guidelines
on Statistical Principles for Clinical Trials and on Choice of
Control Group.
Speaker:
During her PhD and following 6 years in Birmingham, Krys
developed statistical methodology for analysing human variation, with
applications in disease and behaviour. She then spent 7 years with the
newly formed West Midlands CRC Clinical Trials Unit as Head of Statistics
and IT, helping to develop and manage the Unit as well as contributing to
clinical trial methodology. In 1990, she joined Amgen to set up the
Statistics Function in Europe, becoming Director of Statistics and
Clinical Data Management. As well as contributing to the design and
implementation of global clinical programmes leading to product
registrations, she led a group of up to a hundred statisticians and data
managers.
Directions: Head away from Cambridge city centre along the Hills Road.
About 200 yards after the hospital roundabout a road (signposted
'Fulbourn 3') forks off to the left - this is Wort's Causeway.
Strangeways Research Laboratory is the first building on the right on
Wort's Causeway. There is car parking both at the front and the rear of
the building. Access to the building may be difficult after 7:45.
Provisional Next Meeting:
7th October - Ian MacPherson (PRISM) on 'Exploiting Biological Potential'.
Supper: Some members eat regularly in the University Centre before
each talk meeting in the downstairs bar at 6pm. Feel free to join them.
Subscriptions: of 4 pounds per member are now due for the 2001-2002 session.
Cheques should be made payable to Peter Watson and may be posted to
the secretary at the address below.
Secretary: Peter Watson, MRC Cognition and Brain Sciences Unit,
15 Chaucer Road, Cambridge CB2 2EF;telephone 01223 355294 Extension 722;
E-mail [log in to unmask]
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