Quantifying Sex Bias in Clinical Studies at Scale With Automated Data Extraction

  title={Quantifying Sex Bias in Clinical Studies at Scale With Automated Data Extraction},
  author={Sergey Feldman and Waleed Ammar and Kyle Lo and Elly Trepman and Madeleine van Zuylen and Oren Etzioni},
  journal={JAMA Network Open},
Importance Analyses of female representation in clinical studies have been limited in scope and scale. [] Key MethodDesign, Setting, and Participants In this cross-sectional study, clinical studies from published articles from PubMed from 1966 to 2018 and records from Aggregate Analysis of ClinicalTrials.gov from 1999 to 2018 were identified.

Analysis of Female Enrollment and Participant Sex by Burden of Disease in US Clinical Trials Between 2000 and 2020

This study’s findings suggest that sex bias persists within clinical trials, with male and female participants underrepresented in different areas of research.

Sex bias in surgical research

Mind the Gap: Reporting and Analysis of Sex and Gender in Health Research in Australia, a Cross-Sectional Study

Women were significantly underrepresented in cardiology and nephrology studies and overrepresented in psychiatry, care of the elderly, and orthopedic studies and when analyzed by specialty, women are over represented in specialties considered to be female patient dominated, and under Representation of women in some specialties can reinforce gender stereotypes, potentially harming women.

Sex Inequalities in Medical Research: A Systematic Scoping Review of the Literature

The gender gap and misogynistic studies remain present in the contemporary medical literature and Females remain broadly under-represented in the medical literature, sex and gender are poorly reported and inadequately analyzed in research.

Representation of Women in Randomized Trials in Cardiac Surgery: A Meta‐Analysis

The proportion of women in cardiac surgery trials is low and likely inadequate to provide meaningful estimates of the treatment effect, according to a systematic evaluation of cardiac surgery RCTs published in the past 2 decades.

The role of sex and gender in the selection of Alzheimer patients for clinical trial pre-screening

The large number of low-educated elderly women with AD demands for a sex-focused approach in clinical research, and new assessment tools insensitive to education level should be developed to enable a proportional representation of women.

Quantifying 60 Years of Gender Bias in Biomedical Research with Word Embeddings

Overall, it is found that traditional gender stereotypes have reduced over time in biomedical research, but the embeddings of many medical conditions are as biased today as they were 60 years ago.

Harnessing the Power of Sex Differences: What a Difference Ten Years Did Not Make

It is shown that little progress has been made in harnessing the power that sex differences can afford in research for discovery and therapeutic potential for neurological and psychiatric disease to improve the health of men, women and gender diverse individuals.

Large-scale labeling and assessment of sex bias in publicly available expression data

In conclusion, the results demonstrate limited overall sex bias, while highlighting high bias in specific subfields and underscoring the importance of including sex labels to better understand the underlying biology.

State of the evidence: a survey of global disparities in clinical trials

A comprehensive global study investigating the number of randomised controlled trials published on different health conditions, and how this compares with the global disease burden that they impose, finds research priorities are not well optimised to reduce the global burden of disease.



Gender bias in clinical trials: do double standards still apply?

The NIH Revitalization Act does not appear to have improved gender-balanced enrollment or promoted the use of gender-specific analyses in clinical trials published in an influential medical journal.

Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress?

The current level of compliance with guidelines for the inclusion, analysis, and reporting of sex and race/ethnicity in federally funded randomized controlled trials (RCTs) is compared to that from 2004.

Women subjects in NIH-funded clinical research literature: lack of progress in both representation and analysis by sex.

Survey of research articles published in major medical journals shows the need for increased awareness and monitoring of recruitment and retention of women in clinical research and for analysis of data by sex of the subjects to be carried out consistently.

Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials.

Inadequate compliance with NIH-funded clinical trials requires women and minorities as subjects to be included, and the findings illustrate inadequate compliance with the NIH guidelines.

Sex Bias in Hand Surgery Research.

Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute.

Federal efforts to increase the representation of women in clinical trials have been moderately successful primarily because of the institution of a small number of large, single-sex trials involving coronary artery disease.

Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses

Objective To evaluate the frequency, validity, and relevance of statistically significant (P<0.05) sex-treatment interactions in randomized controlled trials in Cochrane meta-analyses. Design

Women encounter ADRs more often than do men

The data confirm the higher risk of ADRs among female subjects compared with a male cohort and identify gender-specific differences in the pharmacokinetic and pharmacodynamic behaviour of drugs as an explanation.

A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results

There is a need to improve the external validity of RCTs such that physicians treating patients in real-world settings have the appropriate evidence on which to base their clinical decisions, by modifying trial design modification to include a more representative patient sample and supplementing RCT evidence with data generated from observational studies.