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Problem
6.1
You
are asked to advise a pharmaceutical company in planning
clinical trials of a Drug P, which relieves neuropathic
pain in diabetic rats. Volunteer studies have been done
to establish a safe upper limit for single oral and intravenous
doses. The company scientists would like to base a "go
- no go" development decision on the outcome of the
following "proof of concept" trial. They would
like to do two-hour intravenous infusions of high-dose Drug
P compared to placebo. Although many other studies in neuropathic
pain have examined repeated doses over several weeks, a
study of this length with Drug P would require expensive
animal toxicology studies of up to several months in duration.
Question
6.1.1
Assuming
that sample size and other aspects of study design are appropriate,
is this brief intravenous study a reliable way to decide
whether to develop the drug further?
 
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