在妇科瘤学临床试验中的人口报告和语言排除
Sarah S Lee1, Andreea I Dinicu2, Likolani Arthurs3
1Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Perlmutter Cancer Center, New York University Langone Health, New York, NY; Bellevue Hospital, New York, NY.
American journal of obstetrics and gynecology
|September 26, 2023
概括
临床试验招生标准,特别是语言排除,可能会限制代表性不足的群体在妇科瘤学中的入学机会. 在研究中报告种族和种族数据仍然不一致,强调需要更大的透明度.
科学领域:
- 妇科瘤学 妇科瘤学
- 临床试验研究 临床试验研究
- 健康差异 在健康上的差异
背景情况:
- 公平获得临床试验对于解决癌症结局差异至关重要.
- 国家癌症组织优先确保公平参与临床试验.
研究的目的:
- 调查临床试验资格标准,这些标准可能会阻碍代表性不足的群体在妇科瘤学中的招生.
- 评估在已发表的妇科瘤学研究中报告的人口信息的情况.
主要方法:
- 在clinicaltrials.gov (1997-2021) 登记的妇科瘤学研究的系统审查.
- 对人口因素的纳入/排除标准的分析和在已发表的研究中报告的人口变量的审查.
- 基于疾病发病率的预期试验入学人数与按种族观察到的入学人数的比较.
主要成果:
- 确定了1500多项妇科瘤学研究;分析了581项已发表的研究以进行人口统计报告.
- 在95%的研究中报告了年龄,在63%的研究中报告了种族,在29%的研究中报告了种族.
- 12%的研究基于语言排除了患者,行业赞助的试验不太可能比研究人员发起的试验这样做. 与子宫癌和卵巢癌试验相比,在宫癌试验招生中观察到显著的种族差异.
结论:
- 在过去三十年中,10个妇科瘤学试验中的1个中存在语言排除.
- 对种族和种族数据的不一致报告需要采取措施来提高患者招募和数据收集的透明度.
- 迫切需要采取行动,以加强代表性不足的人群的招聘,并确保在妇科瘤学研究中全面报告人口统计数据.
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