EU on active control
January 14, 2011
A PLACEBO control arm (where
ethical and feasible) should be
included in pivotal trials which are
used to support marketing
applications, according to the
European Medicines Agency.
The EMA outlines its argument in
a reflection paper published late
last year, saying that the need for
active control must be considered
on a case by case basis.
Recommendations in the paper
include that experimental drugs be
compared with placebos where the
drug may be associated with
mortality or morbidity concerns.
The EMA also said that placebos
should be used where treatment
with a drug of inferior efficacy
might “conceivably lead to significant,
long-term, or irreversible harm”.
“In both scenarios, the comparison
to active control will usually need to
be ‘direct’ (within the same trial),”
the EMA said.
“There are few circumstances
where an indirect comparison
might be considered sufficiently
reliable,” the EMA added.
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