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.
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.