ORGANIZATION OF THE REPORT

The report that follows summarizes the presentations by the expert panelists, and the open panel discussions that took place during the workshop. This report is not intended to be a scholarly review but a detailed accounting of speaker presentations and commentary by panelists and workshop attendees.

An overview of the study of sex differences in biomedical research was provided by experts from four academic institutions and the NIH, and their presentations are summarized in Chapter 2. Discussion focused on the public health importance of studying sex differences in the nervous system, and the potential application of a stronger understanding of these differences to healthcare delivery. Participants discussed when sex differences should be and should not be considered, and how to design preclinical and clinical studies so that sex-based differences can be evaluated.

Chapter 3 provides highlights of four disease/condition-specific panel discussions. Experts discussed the implications of sex differences in translational research in depression, pain and pain perception, sleep medicine, and multiple sclerosis and neuroinflammation. These areas were identified by the planning committee as particularly relevant to the discussion. Issues common across these and other areas of neuroscience research were raised during an overarching discussion following the disease panels.

In Chapter 4, representatives from two key neuroscience professional journals discussed the reporting of sex differences in research publications, and current journal policies on analysis by sex in submitted manuscripts.

Chapter 5 summarizes the panel discussions of the regulatory and industry issues related to sex differences research. Morgan Sheng, vice president of neuroscience at Genentech, gave the keynote address at the workshop, offering an industry view of sex differences in translational neuroscience. Panelists from the FDA, the NIH, and industry discussed the history, guidelines, and regulations regarding the inclusion of males and females in clinical trials, and how and when industry considers and addresses studying sex differences, given current regulatory requirements.

Concluding remarks and discussion of practical next steps by participants are provided in Chapter 6, and the references, list of registered attendees, workshop agenda, and speaker biographies are available in the appendixes.



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