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In
order to use a drug most effectively, one needs the answers
to more questions than can be answered in a single clinical
trial. This section describes a potential sequence in which
an investigator might define the clinical niche of a new
analgesic candidate drug. In terms of the explanatory
vs. pragmatic schema, early studies tend to be explanatory,
looking for "proof of principle". Once this is
demonstrated, the main challenge is more pragmatic in nature,
to learn where the treatment belongs in the set of already
available treatments for various patient groups.
INITIAL EFFICACY STUDY
Experienced
investigators usually seek a "sledgehammer effect"
in an initial efficacy study by using the highest dose that
safety data from studies in healthy volunteers will permit,
and by choosing a well-defined patient population who have
a relatively predictable response to analgesics. Examples
of the latter include postoperative dental pain for pain
related to acute inflammation, and diabetic neuropathy or
postherpetic neuralgia for neuropathic pain. Comparators
(Section 3) would be
placebo and a standard analgesic (if one exists) for the
condition in question.
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