SEMINAR - 17 OCTOBER 2001
The Biostatistics Group and the Manchester RSS are holding a joint
seminar on Wednesday 17 October 2001 commencing at 2.00 pm at MANDEC
(Manchester Dental Education Centre) Higher Cambridge Street,
Manchester. The title is "Drug trials and development" and the
following are the 3 speakers -
SHEILA BIRD (MRC Biostatistics Unit, Institute of Public Health,
Cambridge) Trials and Tribulations: judicial, ethical and NICE
This talk will range over issues such as (consumer principle of)
randomization, confidentiality versus criminality, informed consent,
informative drop-out, database linkage, non-randomized natural history
comparison of effectiveness, epidemiology and design of effectiveness
trials (pharmaceutical or judicial), costs, and public health risk
assessment.
STEPHEN EVANS (UK Medicines Control Agency)
Statistical contributions to assessing safety of medicines
Statistical effort in the development of medicines has tended to be
concentrated on assessing efficacy. When a new medicine is licensed
its safety is always provisional. The major statistical issues relate
to: combining evidence from randomised trials; statistics of rare
events; statistical issues in the interpretation of observational
studies. These topics will be illustrated by reference to hormones and
venous thromboembolism and cancer.
STEPHEN SENN (University College, London)
The identifiability problem: gene by treatment interaction,
pharmacogenomics and cross-over trials
It has been claimed that the human genome project will make clinical
trials "cleaner" by permitting identification and selection
or elimination (as the case may be) of responders and non-responders
for treatment. This would then lead to so-called "theranostic"
treatment strategies in which genetic diagnosis and gene-tailored
treatment are equal partners. I give some grounds for suggesting that
this may be more difficult than has been supposed. I also suggest that
the generally despised (by biostatisticians) cross-over trial may
have a role to play in some would-be theranostic strategies.
All welcome to attend. There is no charge and tea/coffee will be
served mid-afternoon. Please email [log in to unmask] if you will
be attending so that we can arrange enough refreshments.
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