Addressing persistent evidence gaps in cardiovascular sex differences research - the potential of clinical care data

Front Glob Womens Health. 2023 Jan 20:3:1006425. doi: 10.3389/fgwh.2022.1006425. eCollection 2022.

Abstract

Women have historically been underrepresented in cardiovascular clinical trials, resulting in a lack of sex-specific data. This is especially problematic in two situations, namely those where diseases manifest differently in women and men and those where biological differences between the sexes might affect the efficacy and/or safety of medication. There is therefore a pressing need for datasets with proper representation of women to address questions related to these situations. Clinical care data could fit this bill nicely because of their unique broad scope across both patient groups and clinical measures. This perspective piece presents the potential of clinical care data in sex differences research and discusses current challenges clinical care data-based research faces. It also suggests strategies to reduce the effect of these limitations, and explores whether clinical care data alone will be sufficient to close evidence gaps or whether a more comprehensive approach is needed.

Keywords: cardiovascular disease; electronic health records (EHR); epidemiology; real world evidence (RWE); sex differences; women.

Grants and funding

This work was supported by the Dutch Cardiovascular Alliance consortium DCVA IMPRESS (2020B004) and ERC Consolidator grant UCARE (866478). The funders were not involved in the writing of this manuscript.