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M ost biomedical and clinical research has been based on the assumption that the male can serve as representative of the species. This has been true in spite of increasing awareness of significant biological and physiological differences between the sexes, beyond the reproductive ones. Women and men differ in their susceptibility to and risk for many medical conditions, and they respond differently to drugs and other interventions. The close of the previous decade saw 8 out of 10 prescription drugs withdrawn from the U.S. market because they caused statistically greater health risks for women than men. Thus, what is true and good for the gander does not seem to be necessarily good for the goose. After a long history of underrepresentation of women and minorities in clinical trials, federal mandates now require their inclusion in federally funded clinical research in "sufficient [numbers] to provide for a valid analysis of any differences. .. in response to drugs, therapies and treatments." The old paradigm of the "70-kg white male" has finally been replaced by a population sample that attempts to include women and minorities at rates proportional to disease incidence. This evolution of clinical trials has provided much new information about sex differences in healthy and diseased individuals. Sex is a basic biological variable and should be part of the clinical study design when relevant. Already, a few strategies to standardize methods for conducting such studies in animals and humans have been proposed. However, procedures to enhance the collection and analysis of sex-specific data need to be implemented. For instance, female-specific variables, including the stage of ovarian cycle and use of oral contraceptives or hormone replacement therapy, are factors that may influence intervention outcomes. Moreover, routine pharmacokinetic analysis during early phases of drug development (phases I and II) would be advantageous in determining potential sex differences in dosage recommendations and to prevent adverse responses. Critics of sex-specific analysis claim that conducting scientifically rigorous trials with enough statistical power to detect sex differences is prohibitive in terms of time as well as cost. Nevertheless, when prescription drugs are withdrawn from the U.S. market because they cause greater health risks for women than men, the cost of not doing such analyses becomes a greater liability for drug companies. It is not necessary that every large, double-blind, randomized, placebo-controlled clinical trial be sufficiently powered to include sex as a covariant, if appropriate preliminary studies are conducted. Small pilot trials can provide information about drug or treatment efficacy for specific populations. These studies can be useful in establishing procedures, protecting against undesirable outcomes, and determining the statistically significant sample size for subgroup analysis. To this end, common protocols are still needed to determine whether subgroup analysis to detect sex differences must be con...

Obesity has become an international public health concern. In the United States, the rates of overweight and obesity have escalated dramatically in the last several decades. The health implications of obesity stem from its relationship with the development and progression of several health complications and diseases. Cardiovascular disease, which is the number one killer of women and men, is strongly influenced by obesity. The exact biological relationship between these two conditions is difficult to understand because several overlapping physiological systems and processes influence their development. One important component that affects obesity and cardiovascular disease is the sex of the individual. Although this basic biological variable is an obvious area for scientific study, research analyzing the influence of sex on obesity and cardiovascular disease is gravely lacking. The Society for Women's Health Research convened a workshop of obesity and cardiovascular disease experts in November 2005 to identify the gaps in scientific knowledge and crucial next steps in research related to sex differences in obesity and cardiovascular disease. This meeting report describes the workshop attendees' recommendations in detail.

In October 2006, the Society for Women's Health Research convened a workshop that focused on the behavioral and social influences on obesity in women across the life span with an emphasis on ethnicity, socioeconomic status, and mental health. The purposes of the workshop were to examine the current state of the science related to behavioral influences on obesity in women across the life span; to determine the mechanisms, methods, and technical advances required for research progress in this area; and to develop an agenda for future research on behavioral influences on obesity in women. The workshop participants included psychologists, social scientists, clinicians, health educators, health services researchers, nutrition specialists, and epidemiologists, among others, who have expertise in obesity at critical life stages in women (childhood, adolescence, pregnancy, menopause, and older age). Discussions during the workshop focused on 4 specific topics: (1) the relationship between mental or emotional health and obesity in women; (2) the impact of social, cultural, and environmental factors on obesity in women; (3) the improvement of obesity research methodology; and (4) the development of obesity prevention and intervention strategies. Based on these discussions, participants proposed recommendations for future research.

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