International AIDS Society, Geneva, Switzerland.
Centre for the AIDS Programme of Research in South Africa, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
J Int AIDS Soc. 2012 Mar 8;15(1):11. doi: 10.1186/1758-2652-15-11.
Sex and gender differences influence the health and wellbeing of men and women. Although studies have drawn attention to observed differences between women and men across diseases, remarkably little research has been pursued to systematically investigate these underlying sex differences. Women continue to be underrepresented in clinical trials, and even in studies in which both men and women participate, systematic analysis of data to identify potential sex-based differences is lacking. Standards for reporting of clinical trials have been established to ensure provision of complete, transparent and critical information. An important step in addressing the gender imbalance would be inclusion of a gender perspective in the next Consolidated Standards of Reporting Trials (CONSORT) guideline revision. Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as a set of well-recognized and widely used guidelines for authors and biomedical journals, should similarly emphasize the ethical obligation of authors to present data analyzed by gender as a matter of routine. Journal editors are also promoters of ethical research and adequate standards of reporting, and requirements for inclusion of gender analyses should be integrated into editorial policies as a matter of urgency.
性别差异影响着男性和女性的健康和幸福。尽管研究已经引起了对不同疾病中男女之间观察到的差异的关注,但很少有研究致力于系统地调查这些潜在的性别差异。女性在临床试验中的代表性仍然不足,即使在男性和女性都参与的研究中,也缺乏系统地分析数据以确定潜在的基于性别的差异。为了确保提供完整、透明和关键的信息,已经制定了临床试验报告的标准。解决性别失衡问题的重要一步是在下一次《临床试验报告统一标准》(CONSORT)指南修订中纳入性别视角。《生物医学期刊投稿的统一要求》作为一组为作者和生物医学期刊制定的公认的、广泛使用的指南,同样应该强调作者的道德义务,将按性别分析的数据作为常规呈现。期刊编辑也是伦理研究和适当报告标准的推动者,应该将纳入性别分析的要求作为紧急事项纳入编辑政策。