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Dear allstatters,

I have been discussing schemes for a Phase 1 study to look at dose level
and dosage form options for an anti-hypertensive therapy.  My preference
would be for a factorial design, looking a 3 factors at once, but my
medical colleague was not convinced.

In particular, he said that all the studies he had seen were of a simple
parallel group design.
He asked whether there were any precedents for using factorial designs
in phase 1 for cardiovascular agents.

I am well aware of the theoretical advantages of factorial designs and
their practical utility in agricultural and industrial experiments.
However, there seems to be a strong preference in clinical research for
simple designs.

Your mission, should you care to accept it will be to let me know if, in
you experience, factorial designs are useful in Phase 1.  Studies with
cardiovascular agents would be of particular interest.
I would also like to hear negative replies.

Many thanks

Tim Auton

The views, opinions and judgements expressed in this message are solely
those of the author.  The message contents have not been reviewed or
approved by Protherics.


T R Auton PhD MSc C.Math
Head of Biomedical Statistics
Protherics Molecular Design Ltd
Beechfield House
Lyme Green Business Park
Macclesfield
Cheshire SK11 0JL
UK
email: [log in to unmask]