Evidence map›Paper›PMID 26503700›Full record

ArticleBMC women's health2015

Twenty years and still counting: including women as participants and studying sex and gender in biomedical research.

Carolyn M Mazure, Daniel P Jones

Abstract read
In one paragraph

Article in BMC women's health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 130 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Pooled it
  7. Trial
  8. Article
  9. Observational
  10. Review
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  12. Review
  13. Redesigning medicine: integrating sex and gender for better health outcomes.Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Review
  14. Article
  15. Article
  16. Article
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  20. Observational

70 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Carolyn M MazureDepartment of Psychiatry, Yale School of Medicine, New Haven, CT, USA. carolyn.mazure@yale.edu.
Daniel P JonesWomen's Health Research at Yale, Yale School of Medicine, 135 College Street, Suite 220, New Haven, CT, 06510, USA. daniel.jones@yale.edu.

Funding

Yale SCOR on Gender-Sensitive Treatment for Tobacco DependenceP50DA033945 · NIDA · YALE UNIVERSITY · PI MCKEE, SHERRY ANN · 2012 to 2017
$6.5M
Yale BIRCWH Scholar Program on Women's Health and Addictive BehaviorsK12DA031050 · NIDA · YALE UNIVERSITY · PI MAZURE, CAROLYN M. · 2010 to 2014
$2.5M
NIDA NIH HHS K12 DA031050NIDA NIH HHS K12-DA031050NIDA NIH HHS P50 DA033945NIDA NIH HHS P50-DA033945-02
6 · The paper itself

Abstract

backgroundThis 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. DISCUSSION: 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.

Indexed as

Interpersonal RelationsPatient SelectionBiomedical ResearchFemaleHumansMaleRandomized Controlled Trials as TopicUnited States

Identifiers

PMID26503700
PMCPMC4624369

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.