Less than a quarter of the population to participate in clinical trials of antiretroviral drugs are women, potentially limiting the generalizability of the findings, according to a systematic review published in 1 edition of FebruaryJournal of Acquired Immune Deficiency Syndromes.
The authors argue that gender differences in the prevalence, incidence, symptoms, and progression of the disease and the results were recorded in 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) may result in side effects and differences in response to treatment.
Also gender differences in power, personal relationships, life experiences and systemic learning in the field of health can influence people at risk of infection, health seeking behavior and use of health services.
Women's limited participation is a concern for clinical trials across a wide range of disease areas, but the problem seems to be particularly acute in patients with HIV.
Researchers evaluating the clinical trials of antiretroviral drugs (any phase) which were published in eight major medical journals. In order to examine the evolution over time, they selected three time periods: 1994-1997, 2001-2004 and 2008-2011.
In 387 95,305 separate studies with participants, only 23% of the participants were female. The average ratio in each individual study was 19%. The average improved over time - from 9% in the mid-nineties to 22% more recently.
Research conducted in countries with higher incomes have a lower number of female subjects, as well as female, involved in these studies.
Studies funded by charitable foundations and universities recruited more women than pharmaceutical companies and public bodies. Although the US National Institutes of Health have been legally obliged since 1993 the fund only studies that allow gender comparisons, in a significant way, the third of the studies they funded, in part, had only 20% of female participants.
The researchers also examined 53 vaccine trials for HIV prevention. An average of 38% of the participants were women. However in 104 studies working towards a cure for HIV, the average rate of female participation was only 11%, with more than a quarter of non-recruitment of women studies at all despite of both sexes to be eligible.
"Our study showed a persistent under-representation of women in clinical trials of HIV," comment the authors. "Only with sufficient knowledge of sex and gender differences and similarities can take a treatment based on evidence, prevention, care and be delivered for both men and women living with or at risk for HIV optimally."
They note barriers that limit women's participation in the studies - security issues especially in relation to unborn children, requirements to use contraception while taking part in the study, need to take care of family and caring responsibilities honor time commitments is challenging, and socioeconomic inequalities, and as important, poor education and lack of understanding of what represantam studies.
The authors also point to aclinical phase III trial in the United States was set to address these barriersWhere 67% of the participants were women (mostly women of color). Clinics with a large number of female patients (especially in the Deep South) were selected as study sites, even though they had less experience execution of clinical trials; study sites had quotas requiring more female subjects than male participants; an experienced patient advocate worked with clinics about personalized recruitment strategies; outreach activities were conducted; Community groups have been engaged for the reimbursement of transport and reception costs was advertised and enrollment criteria; They were broad.
However those who perform this test reflected that should have given much attention to the retention strategies as for initial recruitment - personalized support to help women to continue working with health can have better retention in this study.
Translated by Claudio Souza, the original Roger Pebody inWomen under-represented in HIV clinical trialsin 12 February 2016