Bots Sophie H, Onland-Moret N Charlotte, den Ruijter Hester M
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.
Laboratory for Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
Front Glob Womens Health. 2023 Jan 20;3:1006425. doi: 10.3389/fgwh.2022.1006425. eCollection 2022.
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.
从历史上看，女性在心血管临床试验中的代表性不足，导致缺乏针对性别的数据。这在两种情况下尤其成问题，一种是疾病在女性和男性中表现不同的情况，另一种是性别之间的生物学差异可能影响药物疗效和/或安全性的情况。因此，迫切需要能恰当代表女性的数据集，以解决与这些情况相关的问题。临床护理数据因其在患者群体和临床测量方面独特的广泛范围，可能非常符合这一要求。这篇观点文章阐述了临床护理数据在性别差异研究中的潜力，并讨论了基于临床护理数据的研究目前面临的挑战。它还提出了减少这些局限性影响的策略，并探讨仅靠临床护理数据是否足以弥合证据差距，或者是否需要更全面的方法。
