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…Â
124 Citations
Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress?
- MedicineJournal of women's health
- 2011
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.
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
- MedicineAcademic medicine : journal of the Association of American Medical Colleges
- 2018
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.
After inclusion, information and inference: reporting on clinical trials results after 15 years of monitoring inclusion of women.
- MedicineJournal of women's health
- 2011
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.
Inclusion of women and gender-specific analyses in randomized clinical trials of treatments for depression.
- Psychology, MedicineJournal of women's health
- 2010
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.
The Persistence of Sex Bias in High-Impact Clinical Research.
- Biology, MedicineThe Journal of surgical research
- 2022
Exclusion of women from clinical research: myth or reality?
- Psychology, MedicineMayo Clinic proceedings
- 2008
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.
Doubly blind: a systematic review of gender in randomised controlled trials
- MedicineGlobal health action
- 2016
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.
Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Devices
- MedicineCirculation. Cardiovascular quality and outcomes
- 2011
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.
Considerations of sex and gender differences in preclinical and clinical trials.
- MedicineHandbook of experimental pharmacology
- 2012
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,…
The inclusion of women and minorities in smoking cessation clinical trials: a systematic review.
- MedicineThe American journal on addictions
- 2009
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.
References
SHOWING 1-10 OF 19 REFERENCES
Gender bias in clinical trials: do double standards still apply?
- MedicineJournal of women's health & gender-based medicine
- 2001
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.
Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities.
- MedicineJournal of clinical epidemiology
- 2003
Women subjects in NIH-funded clinical research literature: lack of progress in both representation and analysis by sex.
- MedicineJournal of women's health & gender-based medicine
- 2000
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.
Participation in cancer clinical trials: race-, sex-, and age-based disparities.
- MedicineJAMA
- 2004
Although the total number of trial participants increased during the study period, the representation of racial and ethnic minorities decreased and were less likely to enroll in cooperative group cancer trials than were whites, men, and younger patients, respectively.
Tracking publication outcomes of National Institutes of Health grants.
- MedicineThe American journal of medicine
- 2005
Sex Differences in Antidepressant Response in Recent Antidepressant Clinical Trials
- PsychologyJournal of clinical psychopharmacology
- 2005
Gender differences in treatment response are not large enough to suggest that gender should guide the clinical use of SSRI and SNRI antidepressants, but the results do have implications for the design and interpretation of antidepressant clinical trials.
Gender differences in symptoms associated with acute myocardial infarction: a review of the research.
- MedicineHeart & lung : the journal of critical care
- 2005
Sex-based differences in the effect of digoxin for the treatment of heart failure.
- MedicineThe New England journal of medicine
- 2002
Digoxin therapy is associated with an increased risk of death from any cause among women, but not men, with heart failure and depressed left ventricular systolic function.
A Randomized Trial of Low-Dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women
- MedicineThe New England journal of medicine
- 2005
Subgroup analyses showed that aspirin significantly reduced the risk of major cardiovascular events, ischemic stroke, and myocardial infarction among women 65 years of age or older, leading to a nonsignificant finding with respect to the primary end point.