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如何优化和评估妇科癌症临床试验中的多样性:GCIG 巴塞罗那会议声明。

How to optimize and evaluate diversity in gynecologic cancer clinical trials: statements from the GCIG Barcelona Meeting.

机构信息

Gynecology with Center for Oncological Surgery, Charite Universitatsmedizin Berlin, Berlin, Germany

North-Eastern German Society of Gynaecological Oncology (NOGGO eV), Berlin, Germany.

出版信息

Int J Gynecol Cancer. 2024 Nov 4;34(11):1677-1684. doi: 10.1136/ijgc-2024-005982.


DOI:10.1136/ijgc-2024-005982
PMID:39496422
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11672020/
Abstract

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.

摘要

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。

相似文献

[1]
How to optimize and evaluate diversity in gynecologic cancer clinical trials: statements from the GCIG Barcelona Meeting.

Int J Gynecol Cancer. 2024-11-4

[2]
Diversity and transparency in gynecologic oncology clinical trials.

Cancer Causes Control. 2023-2

[3]
Racial and ethnic enrollment disparities in clinical trials leading to Food and Drug Administration approvals for gynecologic malignancies.

Am J Obstet Gynecol. 2025-1-23

[4]
The generalizability of NCI-sponsored clinical trials accrual among women with gynecologic malignancies.

Gynecol Oncol. 2016-12

[5]
Racial and Ethnic Disparities in Clinical Trial Enrollment Among Women With Gynecologic Cancer.

JAMA Netw Open. 2023-12-1

[6]
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Am J Obstet Gynecol. 2024-1

[7]
Enrollment of Individuals From Racial and Ethnic Minority Groups in Gynecologic Cancer Precision Oncology Trials.

Obstet Gynecol. 2022-10-1

[8]
Enrollment of Racial and Ethnic Minoritized Groups in Gynecologic Oncology Clinical Trials: A Review of the Scope of the Problem, Contributing Factors, and Strategies to Improve Inclusion.

Clin Obstet Gynecol. 2023-3-1

[9]
Perspectives on inclusion, diversity, equity, and access in clinical trials: findings from a 6-continent survey.

Int J Gynecol Cancer. 2025-2

[10]
The Impact of an International Network (Gynecologic Cancer InterGroup) for Clinical Research on Global Capacity for Gynecologic Cancer Clinical Trials.

Int J Gynecol Cancer. 2017-5

引用本文的文献

[1]
Global determinants of gynecologic cancer incidence and mortality: A cluster-based analysis with predictive insights.

Int J Gynaecol Obstet. 2025-9

[2]
Worldwide barriers of optimal surgical care provision in advanced ovarian cancer.

Int J Gynaecol Obstet. 2025-9

本文引用的文献

[1]
Cervical cancer treatment update: A Society of Gynecologic Oncology clinical practice statement.

Gynecol Oncol. 2023-12

[2]
Telehealth utilization in gynecologic oncology clinical trials.

Gynecol Oncol. 2023-10

[3]
Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup.

Lancet Oncol. 2022-8

[4]
Race/ethnicity reporting and representation in US clinical trials: a cohort study.

Lancet Reg Health Am. 2022-7

[5]
Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

J Clin Oncol. 2022-7-1

[6]
Racial and Ethnic Differences in Hysterectomy-Corrected Uterine Corpus Cancer Mortality by Stage and Histologic Subtype.

JAMA Oncol. 2022-6-1

[7]
Despite The FDA's Five-Year Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs.

Health Aff (Millwood). 2022-3

[8]
African American participation in cancer clinical trials.

Ecancermedicalscience. 2021-10-25

[9]
Racial and Ethnic Disparities Among Participants in Precision Oncology Clinical Studies.

JAMA Netw Open. 2021-11-1

[10]
Integrating Research into Community Practice - Toward Increased Diversity in Clinical Trials.

N Engl J Med. 2021-10-7

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