Joint meeting Manchester University's Biostats Group on "Drug trials and development"

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.

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.

Stephen Evans' Presentation (this is a personal view)
Stephen Senn's Presentation