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Rochester, MN, USA. Are the health needs of women adequately addressed by medical research as it is currently conducted? Researchers say a growing body of evidence shows important differences between men and women must be addressed by medical research, including how they respond to treatment and the long-term outcomes. Australian researchers and two cardiologists examine this question in the Mayo Clinic Proceedings, published by Mayo Foundation for Medical Education and Research.
"The traditional model of medical research was limited by gender and racial blindness and assumed that results of research on white male participants could be easily extrapolated to female and minority populations," write Wendy Rogers, B.M.B.S., Ph.D., and Angela Ballantyne, Ph.D., from the School of Medicine at Flinders University (Adelaide, AUS).
Exclusion of Women From Clinical Research: Myth or Reality? Wendy A. Rogers; Angela J. Ballantyne; for the Australian Gender Quity In Health Research Group. Mayo Clin Proc. 2008;83(5):536-542.
Drs. Rogers and Ballantyne reviewed 400 clinical studies that were conducted in Australia and the results were published in journals between Jan. 1, 2003 and May 31, 2006. The research provides data about issues that include:
the number of men versus women participating in research on diseases affecting both genders;
the number of studies classified as female-only research and male-only research; and
the degree to which studies provided gender-specific data and analysis.
Wendy Rogers, B.M.B.S., Ph.D., School of Medicine at Flinders University (Adelaide, AUS).
"Analysis such as this is essential for determining whether the national research agenda is addressing issues in both men's and women's health and the extent, if any, of inappropriate exclusions of either gender from potentially beneficial research," write Drs. Rogers and Ballantyne.
At first glance, the numbers collected by the Australian team do not suggest that women are under-represented in the research they examined.
Of the 546,824 persons studied, 73 percent were female. However, the team points out that these numbers were largely due to the greater number and size of female-only studies.
When Drs. Rogers and Ballantyne looked at the type of research in which men and women participated, they discovered that male participants were more than three times as likely to be involved in research into conditions affecting both men and women.
Other data provided by the Australian team indicates that gender-specific reporting of results in women is particularly lacking in pharmaceutical research.
"Research on women's health continues to focus predominantly on their reproductive capacity and function, whereas research with men continues to investigate conditions that are not specific to one sex," write Drs. Rogers and Ballantyne. The result, say the authors, is that women are underrepresented in research focusing on significant health issues that are unrelated to biological aspects of reproduction.
Despite the growing literature on the clinical importance of gender, the Australian team noted that the majority of the 400 studies reviewed did not analyze the potential role of participant's gender in their published research. Drs. Rogers and Ballantyne recommend that clinical trials registries collect data on the gender of participants "to facilitate further research in this area and that researchers, journal editors, and peer reviewers work to standardize mechanisms for sex-specific reporting and analysis in publications."
Editorial: Mayo Clinic Proceedings. In a companion editorial, cardiologists Sharonne N. Hayes, M.D., director of the Mayo Clinic Women's Heart Clinic, and Rita Redberg, M.D., from the University of California, San Francisco, explore the historical context surrounding the limited role of women participating in medical research and provide additional data that echo the findings of the Australian team.
"We observed the same phenomenon in a recent review of cardiology clinical trials where only 25 percent of all studies reported results by sex. As heart disease is the leading cause of death in women, it is dismaying that data from cardiovascular clinical trials are so limited," write Drs. Hayes and Redberg.
Noting that unexpected gender-based differences have been found in many diseases, including lung cancer, degenerative joint disease, depression and other mental health disorders, Drs. Hayes and Redberg assert that "the lack of sex differences should not be assumed and instead must be systematically studied." Given this information, "analyzing data by sex for conditions or treatments affecting both men and women is the only way we will be able to begin to provide optimal care for all patients," they write.
Dispelling the Myths: Calling for Sex-Specific Reporting of Trial Results. Sharonne N. Hayes; Rita F. Redberg. Mayo Clin Proc. Editorial: 2008;83:523-525. [ Download PDF ]
Editorial
Extract. Exclusion of women from clinical trials has its origins in the centuries-old concept of protecting women and children from harm. The logical result of this effort was that women of childbearing age were barred from participating in most medical research. Unfortunately, this reasonable, if somewhat paternalistic, effort to avoid harming fetuses by not enrolling pregnant participants in early-phase drug trials was overenthusiastically expanded to a virtual ban on all women in clinical trials. Additional reasons given for excluding women from research studies include the real and perceived challenges of “controlling” for cyclic hormonal effects on outcomes and the widely held assumption that any results derived from male-only research could be applied to women.
Sex-based medicine traditionally has been thought of as the study and treatment of conditions affecting only men or only women, such as reproductive health and sex-specific cancers. Only in the past decade or so have researchers widely recognized the many biological differences between the sexes. Sex-based differences in natural history of disease, epidemiology, pathophysiology, diagnostic accuracy of tests, response to therapy, and outcomes have all been identified in a range of diseases and conditions previously thought to be “gender neutral.” Despite findings in 1985 from the US Public Health Service Task Force on Women’s Health Issues1 that excluding women from clinical studies had led to a lack of knowledge about women’s biology and that this deficiency had compromised the health of women, male domination in clinical trial enrollment continued.
Exclusion of Women From Clinical Research: Myth or Reality? Wendy A. Rogers; Angela J. Ballantyne; for the Australian Gender Quity In Health Research Group. Mayo Clin Proc. 2008;83(5):536-542.
Abstract
Objective. To determine the proportion of male and female research participants and rates of sex-based analysis and sex-specific reporting in published Australian clinical research.
Participants And Methods. We assessed 400 clinical studies involving Australian-only participants, published in journals between January 1, 2003, and May 31, 2006 (100 per year). Numbers of male and female participants in each study and presence or absence of analysis by sex (covariate adjustment, subgroup analysis, or sex-specific reporting) were recorded. Sex-specific studies were evaluated to determine whether the exclusion of one sex was biologically necessary.
Results. The total sample comprised 546,824 participants, of whom 73% were female; 36 studies were male-only, 78 were female-only. Of the participants in 286 studies that were not sex-specific, 56% were female. Of 114 sex-specific studies, the segregation by sex was deemed to be biologically necessary in 62%, ie, the research related directly to male or female biological function. More than one-quarter (28%) of studies with 30 participants or more published covariate adjustment or subgroup analysis by sex; 7% included sex-specific reporting of results.
Conclusion. We found no routine exclusion of women; however, few publications analyzed results by sex. Some studies excluded women or men for apparently arbitrary reasons. Research performed with male-only participants differed in nature and size from that performed with female-only participants. These data indicate the need to track the sex of research participants. In addition, they 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.
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