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Women under-represented in HIV clinical trials
Roger Pebody, 2016-02-08 07:10:00
Less than a quarter of people taking part in clinical trials
for antiretroviral medications are women, potentially limiting the
generalisability of findings, according to a systematic review published in the
February 1 edition of the Journal of
Acquired Immune Deficiency Syndromes.
The authors say that gender differences in prevalence,
incidence, symptoms, disease progression and outcomes have been noted across a
range of diseases. Differences in pharmacokinetics
(how drugs are absorbed and distributed in the body) and pharmacodynamics
(the effect of a drug on the body) can result in differences in side-effects
and response to treatment.
Moreover gender differences in power, personal relationships, life experiences and
health literacy can influence people’s risk of infection, health-seeking
behaviour and use of health services.
Limited participation of women is a concern for clinical
trials across a wide range of disease areas, but the problem appears to be
particularly acute in HIV.
The researchers searched for clinical trials of
antiretroviral medications (of any phase) that were published in eight major
medical journals. In order to examine evolution over time, three time periods
were selected: 1994-1997, 2001-2004 and 2008-2011.
In 387 separate studies with 95,305 participants, only 23%
of participants were female. The average proportion in each individual study was 19%. The
average has improved over time – from 9% in the mid-1990s to 22% more recently.
Research conducted in higher-income countries involved fewer
Studies funded by universities and charitable foundations recruited
more women than pharmaceutical companies and public bodies. Although the US
National Institutes of Health has been legally obliged since 1993 to only fund
studies which will allow meaningful gender comparisons, in the third of the
studies which they part-funded only 20% of participants were women.
The researchers also examined 53 clinical trials of vaccines
for HIV prevention. An average of 38% of participants were women. However in
104 studies working towards a cure for HIV, the average rate of female
participation was only 11%, with over a quarter of studies recruiting no women at
all despite both sexes being eligible.
“Our study showed a persistent under-representation of women
in HIV clinical trials,” comment the authors. “Only with sufficient knowledge
of sex and gender differences and similarities can optimal and evidence-based
treatment, prevention, and care be delivered to both women and men living with
or at risk for HIV.”
They note barriers limiting women’s participation in studies
– safety concerns especially in relation to unborn children, requirements to
use contraceptives while taking part, family and caregiving responsibilities
making time commitments challenging, socio-economic inequalities, low education
and lack of understanding of what trials are.
The authors also point to a phase III clinical trial in the
United States which set out to address these barriers and in which 67% of
participants were women (mostly women of colour). Clinics with large numbers of
female patients (primarily in the Deep South) were selected as study sites even
if they had less experience of running clinical trials; study sites had quotas
requiring more female than male participants; an experienced patient advocate
worked with clinics on tailored recruitment strategies; outreach activities were
conducted; community groups were engaged with; the reimbursement of transport and
childcare costs was publicised; and enrolment criteria were broad.
those running this trial reflected that they should have given as much attention
to retention strategies as to initial recruitment – individualised support to
help women continue to engage with healthcare might have improved retention in this study.