FDA Proposes Rule on Women in Clinical Trials
Contact:
Food and Drug Administration
Susan M. Cruzan: 301-827-6242
Broadcast Media: 301-827-3434
Consumer Hotline: 800-532-4440
Source:
Food and Drug Administration (FDA)
September 23, 1997
FDA today proposed a rule that would ensure that women are not excluded from
participating in early studies of drugs and biologics to treat
life-threatening diseases
just because of their reproductive potential. The following may be used to
respond
to inquiries.
In a notice to be published in tomorrow's Federal Register, the agency is
requesting public comment on a proposal that would prevent the routine
exclusion
of either men or women from clinical studies because of potential risks of
toxicity
to offspring or reproductive organs.
The proposed rule would permit FDA to place a trial on clinical hold (not
allow
the study to be conducted or to continue) if a sponsor proposes to exclude
or is
excluding women from a trial for inappropriate reasons.
FDA's proposal reflects a significant evolution of thought about
participation of
women of reproductive potential in clinical studies during the past two
decades,
and is in keeping with the agency's l993 guideline encouraging women's
participation in all phases of clinical trials.
FDA prepared this proposal after the National Task Force on AIDS Drug
Development and the Presidential Advisory Council on HIV/AIDS recommended
that women with HIV or AIDS, particularly those of reproductive potential,
not be
excluded from investigational trials intended to study a therapy for a
life-threatening disease.
Many of the women who are affected by HIV and AIDS are young women with
reproductive potential.
The council's recommendation, along with limited surveys of some applications
showing the exclusion of women of reproductive age in some clinical trials,
including some trials of drugs for life-threatening illness, led to
today's proposal.
In developing this proposal FDA focused on several important factors:
First, FDA is committed to expanding access to and accelerating
approval of new therapies for life-threatening diseases. FDA
recognizes that physicians and patients are generally willing to accept
greater potential risks or side effects from medical products to treat
life-threatening diseases.
Second, FDA believes that patients, including women of
reproductive potential, in concert with their partners and doctors,
can make their own risk/benefit decision when provided with
thorough information about risks and potential benefits by the clinical
investigator. The informed consent process, required by law for
participation in all studies, provides information intended to describe
known and potential risks, including potential risks to the embryo or
fetus, should a woman become pregnant.
By encouraging diversity at all stages of a drug's development, FDA hopes
that
drug sponsors will generate better data about how the drug will affect the
populations that will receive it once it is marketed. The agency believes
it is
important to identify important information about a drug during the
investigational
phase, such as dosages for different age groups, genders, and racial
subgroups,
and to use that information to refine labeling information, patient
selection, and
dose selection.
It is important to note that the proposed rule would not require specific
recruitment goals for women, nor would it apply to all clinical trials.
For example,
it would not apply to:
Clinical trials designed to look at healthy volunteers exclusively;
trials designed to test drugs for special circumstances, such as in
gender
specific populations such as drugs for prostate cancer; or
trials designed exclusively for men so long as a companion study in
women
of reproductive potential has been planned or is being conducted.