This paper chronicles attempts in the United States over the
past 20 years to fully represent women in clinical trials and ensure the
study of sex and gender in biomedical research. We maintain that productive
science with the aim of serving the public health requires examining the
influence of sex and gender on health outcomes.
This section provides a historical perspective on the
changes in recommendations and requirements of both the National Institutes of
Health — the world’s largest single funder of biomedical research — and the
U.S. Food and Drug Administration — the world’s most influential regulator of
drugs and medical devices — for the acceptable conduct of research as it
relates to sex and gender. We also cite all reports by the U.S. Institute of
Medicine and the U.S. Congress’ General Accountability Office issued from 1990 to
the present on the inclusion of sex and gender in research, and selected
high-impact published studies that illustrate and document the paucity of, yet
the need for, inclusion of females and consideration of sex and gender in
research across an array of biomedical disciplines.
The key message of this paper is that it has been
20 years since the first requirements to include women as well as men in
clinical trials and analyze results by sex were mandated by a U.S. federal law,
yet not nearly enough progress has been made. Recent signs of potential change
in both policy and practice of scientific inquiry suggest much more progress
may be within reach. However, awaiting a cultural shift to allow the study of
sex and gender to be embraced is not seen as an effective strategy for change.
Rather, specific instrumental recommendations are offered for how to include
the study of sex and gender in research so as to increase our understanding and
promotion of health for the benefit of all.
Full article
at:
1Department of Psychiatry, Yale School of
Medicine, New Haven, CT, USA
2Women’s Health Research at Yale, Yale
School of Medicine, 135 College Street, Suite 220, New Haven 06510, CT, USA
More at: https://twitter.com/hiv_insight
No comments:
Post a Comment