Guidelines Regarding
Trials Involving Potentially Teratogenic Agents in Men and Women
of Reproductive Potential
For trials involving potentially teratogenic agents, it may be
appropriate to include a statement in the protocol document and
in the informed consent that it is strongly recommended that
women avoid pregnancy and men avoid fathering children while
receiving treatment.
The Food and Drug Administration (FDA) has concluded that (1)
exclusion of women from early trials is not medically necessary
because the risk of fetal exposure can be minimized by patient
behavior and laboratory testing, and (2) initial determinations
about whether that risk is adequately addressed are properly left
to patients, physicians, local IRBs and sponsors, with
appropriate review and guidance by the FDA (58 FR 39406 [July 22,
1993]). The FDA stated that
appropriate precautions should be taken in clinical
studies to guard against inadvertent exposure of fetuses to
potentially toxic agents and to inform subjects and patients of
potential risk and the need for precautions. In all cases the
informed consent document and investigator’s brochure should
include all available information regarding the potential risk of
fetal toxicity. If animal reproductive toxicity studies are
complete, the results should be presented, with some explanation
of their significance in humans. If these studies have not been
completed, other pertinent information should be provided, such
as a general assessment of fetal toxicity in drugs with related
structures or pharmacologic effects. If no relevant information
is available, the informed consent should explicitly note the
potential for fetal risk.
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