Workshop on Sex Differences and Implications for Translational Neuroscience Research
Basic research that involves delineating meaningful drug effects and behavioral and physiological responses that differ between the sexes can be costly and time consuming because they require additional experiment groups and protocols. However, epidemiological and clinical studies indicate substantial sex differences in response to drugs. The sex differences cut across other parameters such as socioeconomic factors, race, age, etc. In the current era of translational research and personalized medicine, it is increasingly important to take sex differences into account, so that these drug effects can be more accurately understood. This is particularly important in the neurosciences because of the complex nature of many disorders of the nervous system including mental, neurological, and substance use disorders. Consequently, the Institute of Medicine’s Forum on Neuroscience and Nervous System Disorders hosted a workshop to explore the key principles and strategies used by basic translational researchers and industry in studying sex differences in the neurosciences for the therapy development pathway.
The objectives of this workshop were to:
- Briefly outline the public health importance of studying sex difference in the nervous system, in health and sickness, including the potential application to healthcare delivery.
- Identify the scientific principles that should be considered when designing pre-clinical experiments that will examine sex differences, including strategies to bridge between pre-clinical and clinical studies
- Discuss when and how sex differences should and should not be considered.
- Explore the key principles and strategies used by academic clinicians to effectively utilize basic research for pre-clinical and clinical application and study (i.e., phase 0-4), including approaches used by researchers to decide how and when to take into consideration the potential importance of sex differences.
- Explore how and when industry considers and addresses studying sex differences, given regulatory guidelines.
- Examine the advantages, constraints, and implication of performing “valid analysis” versus requiring statistical outcomes between the sexes.
- Identify the next steps that will be critical to establishing a set of principles that could be used by a variety of stakeholders in considering when and how to incorporate studying sex differences into translational research efforts