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THE RESEARCHER PERSPECTIVE: COLLECTING,ANALYZING, AND REPORTING SEX-SPECIFIC DATA
Pages 11-20

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From page 11...
... Challenges emerge in designing experiments, applying for grants, and making the most of limited funding inasmuch as these activities build on the existing knowledge base, which is historically biased toward males. Collecting the Data: Sex in Biomedical Research The Politics of Sex Differences Biases against studying females are embedded in the research culture, and there are numerous misconceptions, said Larry Cahill, professor of neurobiology and behavior at the University of California, Irvine.
From page 12...
... One argument that is true is that the cyclic nature of female sex hormones necessitates larger samples and more test groups in rodent work. Studying females requires more time, is more labor-intensive, and is more expensive than studying only males.
From page 13...
... She asked how these large, expensive trials might have been designed differently if pharmacokinetics or responsiveness or the stage of the disease had been studied in both male and female animals. The blame for failed clinical trials is shared equally by the clinical researchers who design and conduct the trials and the basic researchers who continue to publish data on only males or only females because it is easier.
From page 14...
... Wong pointed out the problems of type I and type II errors, and the often greater concern about the former, and the problem of statistical power where an inadequate sample size increases the chance of a type II error. Wong further explained that two types of errors can occur in association with a hypothesis that there is no difference between drug and placebo (Table 1)
From page 15...
... of the remaining 992 women who do not have breast cancer would have positive mammograms. The Bayes rule, or a Bayesian interpretation, Wong explained, would suggest that the probability of breast cancer in those with positive mammograms is 7 of the total positive mammograms (7 + 69)
From page 16...
... In other words, a Bayesian integration gains strength from prior information whereas a frequentist approach cannot. A Bayesian approach formally integrates prior knowledge with data ("sequential learning")
From page 17...
... There are methodologic challenges to risk stratification, he noted, including the need for an independent determination of the risk groups, and there is a potential for type I and type II errors. Reporting the Data A Role for Journals Silver referred participants to the report of a 2010 IOM workshop, Sex Differences and Implications for Translational Neuroscience
From page 18...
... Journal policies determine manuscript reporting requirements, Silver said, and if journal editors believe that it is important to know the sex of origin of a cell type that is being studied or the sex of animal or human participants, investigators will have to include that information.
From page 19...
... Sex-Based Comparisons vs Reporting of Participant Sex Judith Lichtman, associate professor in the Department of Epidemiology and Public Health at Yale University School of Medicine, suggested that in considering standardization of journal policies for sexspecific reporting, it is important to remember that there are studies that are designed to assess sex-based differences, or of which such assessment is a natural extension, and studies in which sex-related data would be interesting to know but are not necessarily the focus. Studies designed to analyze by sex and studies that simply note the sex of participants as an observation present different methodologic issues.
From page 20...
... Data on Sex-Specific Reporting Pinn stressed that in looking at data on sex-specific reporting, it is important to know what studies the data are based on, for example, whether the data are only for clinical trials, or for clinical trials and observational studies, or whether the data are for studies funded by NIH or for all studies. She noted that NIH has been conducting analyses of clinical research and in looking at 12,000 protocols in FY 2010 found that 56% of the 23.3 million participants were women.


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