Gynecology with Center for Oncological Surgery, Charite Universitatsmedizin Berlin, Berlin, Germany
North-Eastern German Society of Gynaecological Oncology (NOGGO eV), Berlin, Germany.
Int J Gynecol Cancer. 2024 Nov 4;34(11):1677-1684. doi: 10.1136/ijgc-2024-005982.
Findings from clinical trials have led to advancement of care for patients with gynecologic malignancies. However, restrictive inclusion of patients into trials has been widely criticized for inadequate representation of the real-world population. Ideally, patients enrolled in clinical trials should represent a broader population to enhance external validity and facilitate translation of outcomes across all relevant groups. Specifically, there has been a systematic lack of data for underrepresented groups, with many studies failing to report or differentiate study participants based on sociodemographic domains, such as race and ethnicity. As such, the impact of treatment in these underrepresented groups is poorly understood, and clinical outcomes according to various sociodemographic factors are infrequently assessed. Inclusion of diverse trial participants, with different racial and ethnic background, is essential for the understanding of factors that may impact clinical outcomes. Therefore, we conducted a multi-national meeting of clinical trial groups and industry with the goal of increasing equity, diversity, and inclusion in gynecologic cancer clinical trials and to address barriers to recruitment, participation, and harmonization of data collection and reporting. These Gynecologic Cancer Intergroup (GCIG) statements present recommendations and strategies for the gynecologic cancer research community to improve equity, diversity, and inclusion in gynecologic cancer clinical trials.
临床试验的结果推动了妇科恶性肿瘤患者的治疗进展。然而,由于试验对患者的纳入限制过于严格,未能充分代表真实世界的人群,因此受到了广泛的批评。理想情况下,临床试验纳入的患者应代表更广泛的人群,以增强外部有效性,并促进所有相关人群的结果转化。具体来说,代表性不足的人群的数据一直存在系统缺失,许多研究未能根据社会人口统计学领域(如种族和民族)报告或区分研究参与者。因此,这些代表性不足的人群中治疗的效果理解不足,根据各种社会人口统计学因素评估的临床结果也很少。纳入具有不同种族和民族背景的多样化试验参与者对于理解可能影响临床结果的因素至关重要。因此,我们召开了一次多国家临床试验组和行业会议,旨在增加妇科癌症临床试验中的公平性、多样性和包容性,并解决招募、参与以及数据收集和报告协调方面的障碍。这些妇科癌症国际协作组(GCIG)的声明为妇科癌症研究界提出了建议和策略,以改善妇科癌症临床试验中的公平性、多样性和包容性。
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