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

@article{Geller2006AdherenceTF,
  title={Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials.},
  author={Stacie E Geller and Marci G. Adams and Molly L Carnes},
  journal={Journal of women's health},
  year={2006},
  volume={15 10},
  pages={
          1123-31
        }
}
BACKGROUND The National Institutes of Health Revitalization Act of 1993 requires that NIH-funded clinical trials include women and minorities as subjects; other federal agencies have adopted similar guidelines. The objective of this study was to determine the current level of compliance with these guidelines in federally funded randomized controlled trials. METHODS Randomized controlled trials published in nine influential medical journals in 2004 were identified by PubMed search. Studies… Expand
Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress?
TLDR
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. Expand
The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials
TLDR
Investigating current levels of compliance with NIH guidelines for inclusion, analysis, and reporting in NIH-funded randomized controlled trials (RCTs) and comparing the results with those from 2009 and 2004 found NIH policies have not resulted in significant increases in reporting results by sex, race, or ethnicity. Expand
After inclusion, information and inference: reporting on clinical trials results after 15 years of monitoring inclusion of women.
TLDR
Efforts at including women in clinical research have increased the information captured relative to women's health and improved reporting and disseminating sex/ gender-specific results will allow sex/gender-specific inferences and healthcare decisions. Expand
Inclusion of women and gender-specific analyses in randomized clinical trials of treatments for depression.
TLDR
Examination of the inclusion of women and gender-specific analyses in recent randomized clinical trials (RCTs) for depression finds many recent studies of depression treatments include women but do not examine outcomes by gender. Expand
Sex and race/ethnicity reporting in clinical trials: a necessity, not an option.
TLDR
It is demonstrated that women and people of color continue to be underrepresented in clinical trials and that sex and race=ethnicity-specific results are still infrequently reported, which limits the ability to establish appropriate guidelines for the prevention, diagnosis, and treatment of a multitude of diseases. Expand
Exclusion of women from clinical research: myth or reality?
TLDR
Data indicate the need to track the sex of research participants and provide the basis for assessing appropriate inclusion of men and women in research and for comparing any relationship between different international regulatory models and the rates of female participation in research. Expand
Doubly blind: a systematic review of gender in randomised controlled trials
TLDR
Social characteristics like sex/gender remain hidden from analyses and interpretation in RCTs, with loss of information and embedding of error all along the path from design to interpretation, and therefore to uptake in clinical practice. Expand
Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Devices
TLDR
There is a lack of sex-specific safety and effectiveness data for high-risk cardiovascular devices before FDA approval and justifications for this lack of evidence may perpetuate the status quo, which could present an opportunity to improve cardiovascular outcomes. Expand
Considerations of sex and gender differences in preclinical and clinical trials.
Women continue to be underrepresented in clinical trials, particularly in Phases I and II of experimental drug studies in spite of legislative guidelines in the USA, Canada, the European Union,Expand
The inclusion of women and minorities in smoking cessation clinical trials: a systematic review.
TLDR
Female representation, while commensurate with population levels, declined significantly for trials that began recruitment after 1993, and minorities continued to be under-represented in later trials; however, significant improvement in representation and analysis by race occurred. Expand
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