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 In an analysis spanning several decades that included work done as
recently as 2012, researchers found that women typically comprised
about 11 percent of participants in trials investigating cures for
HIV. Similarly, drug studies were only about 19 percent female and
just 38 percent of vaccine trial subjects were women.
“Based on previous studies in other health areas, it wasn’t
surprising, but perhaps disappointing given that nearly half of
those living with HIV are women,” lead study author Dr. Mirjam Curno,
who did the analysis while working as managing editor of the Journal
of the International AIDS Society, said by email.
Research in areas such as heart disease, cancer and depression has
also had historically low female participation, as have advanced
human trials testing experimental drugs, Curno and colleagues note
in the Journal of Acquired Immune Deficiency Syndromes.
While it may make sense to have fewer women in studies focused on
diseases that disproportionately affect men, research findings may
overlook gender-specific harms or benefits when the proportion of
men and women in the study is wildly different from what happens in
the real world, said senior study author Dr. Shirin Heidari by
email.
That’s because even when the disease is the same, women may have
different symptoms than men and respond in unique ways to the
treatments being tested.
“Failing to systematically study sex and gender differences in
health research leads to less evidence-based medicine for one sex or
another,” said Heidari, who is chair of the gender policy committee
for the European Association of Science Editors.
The analysis of gender disparities in HIV trials included more than
500 studies published in prominent medical journals over several
decades.
One limitation of the analysis is that by relying on published work,
it may not capture any differences in the gender makeup of more
recent trials that haven’t yet been completed, the authors
acknowledge.
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It’s possible that at least some studies in the analysis didn’t set
out to favor men, but ended up enrolling fewer female participants
due to obstacles that can disproportionately impact women such as
lack of child care or elder care or limited transportation or time
to participate, noted Mary Foulkes, a biostatistics researcher at
George Washington University in Washington, D.C.
One question not answered by the analysis is why eligible women may
have decided not to participate, Foulkes, who wasn’t involved in the
study, said by email.
Sometimes, trial enrollment criteria can be too restrictive to
enroll enough women, for example by barring women who are pregnant,
nursing or of childbearing age. In the past, eligibility criteria
have excluded large numbers of women even in HIV trials designed to
study female patients, noted Dr. Monica Gandhi, an HIV specialist at
the University of California, San Francisco.
Women’s underrepresentation in HIV trials can make the findings of
limited use in treating female patients, Gandhi, who wasn’t involved
in the study, said by email.
“When I take care of an HIV-infected woman in my clinic, I do not
know if this new and exciting treatment or strategy applies
specifically to her if the trial did not include enough people in
their study that look like her,” Gandhi said.
SOURCE: http://bit.ly/1JKDP44 Journal of Acquired Immune Deficiency
Syndromes, online September 8, 2015.
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