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Suggested Citation:"CLOSING REMARKS." Institute of Medicine. 2012. Sex-Specific Reporting of Scientific Research: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13307.
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Fourth, Adler mentioned earlier discussions about requiring sex-stratified analyses. She reminded participants that it was noted that requiring identification of sex-specific information is easier to implement than requiring sex-specific analyses, but possibly less effective than requiring them. Editorial policies that require sex-stratified analysis would affect how studies are designed and conducted, not only how they are reported. The ultimate goal would be a culture change in scientific research that embraces sex as a key variable for analysis.

CLOSING REMARKS

Clayton offered closing comments on behalf of the workshop sponsor. The purpose of research is to inform, she said, and, for those involved in health research, to increase knowledge about human biology and to foster development of evidence-based health policy and clinical care.

Journal editors, Clayton pointed out, are uniquely positioned as gatekeepers for much of the scientific knowledge that reaches the public domain. They have the power to advance appropriate consideration of sex differences, she said, acknowledging that the term appropriate is subject to interpretation and that “one size does not fit all.” Journal editors and editorial bodies, such as the ICMJE, can set standards for the inclusion of sex-related information in manuscripts submitted to their publications, including the sex of origin of tissues and cells and the sex of animals and humans in preclinical and clinical studies. They are also in a position to set guidelines to encourage authors to think about analysis and reporting of sex differences.

Clayton reiterated that NIH requires the inclusion of women and minorities, as scientifically appropriate, in all clinical research that is supported by NIH. For a phase 3 clinical trial, if an evidence review reveals a likelihood of a sex-based difference, the study must be designed to allow comparisons between males and females, and the results must be provided to NIH in the final progress report. However, NIH does not have any control over what is published in the scientific literature. Together, the scientific community needs to find ways to ensure that this information gets out so that it can be helpful to researchers, clinicians, and policy-makers, she said. Funding is more limited than at other times, so scientists should also be efficient in collecting as many data as possible from studies. She concluded by noting that patients who participate in trials are relying on researchers to get the maximum information from clinical research.

Suggested Citation:"CLOSING REMARKS." Institute of Medicine. 2012. Sex-Specific Reporting of Scientific Research: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13307.
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The number of women participating in clinical trials has increased during the last two decades, but women are still underrepresented in clinical trials in general. Some of the overall increase can be attributed to the greater number of women-only trials (of therapies for diseases that affect only women). Even when women are included in clinical trials, the results are often not analyzed separately by sex.

On August 30, 2011, the Institute of Medicine (IOM) Board on Population Health and Public Health Practice hosted the workshop Sex-Specific Reporting of Scientific Research. The workshop explored the need for sex-specific reporting of scientific results; potential barriers and unintended consequences of sex-specific reporting of scientific results; experiences of journals that have implemented sex-specific requirements, including the challenges and benefits of such editorial policies; and steps to facilitate the reporting of sex-specific results. Presenters and participants included current and former editors of scientific journals, researchers, and scientists and policymakers from government, industry, and nonprofit organizations. Presentations and discussions highlighted the importance to both women and men of having sex-specific data, the problems with sample size and financial constraints for conducting the research, the appropriateness of sex-specific analyses, and the limitations of journal policies to change experimental designs.

Sex-Specific Reporting of Scientific Research summarizes the presentations and discussions by the expert panelists during the IOM workshop. The workshop's first session focused on why sex-specific reporting is important. Panelists highlighted historical and current events that have hindered or helped to advance the study of women. In the next session, panelists in academe discussed the challenges of collecting, analyzing, and reporting sex-specific data from the researcher's perspective. That was followed by two panels of leading journal editors who shared their experiences in developing and implementing editorial policies and the implications of sex-specific reporting policies for journals.

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