Background The objective of this study was to evaluate whether sex- and gender-based analyses and proper sex- and gender-terminology were used in oncology trials leading to regulatory drug approval. Methods The Food and Drug Administration (FDA) Hematology/Oncology Approvals and Safety Notifications page was used to identify all anti-cancer therapies that received FDA approval between 2012 and 2019. The trials used to support FDA-drug approval were collected along with all available supplemental tables and study protocols. Documents were reviewed to determine if there was a plan to analyze results according to sex and gender and to determine if consistent sex and gender terminology were used. Results 128 randomized-controlled trials were identified corresponding to a cancer medicine which received FDA-approval. No study specified how sex and gender were collected or analyzed. No study reported any information on the gender of participants. Sex and gender terminology was used inconsistently at least once in 76% (97/128) of studies. Among the 102 trials for non-sex-specific cancer sites, 89% (91/102) presented disaggregated survival outcome data by sex. No study presented disaggregated toxicity data by sex or gender. Conclusion The majority of pivotal clinical trials in oncology fail to account for the important distinction between sex and gender and conflate sex and gender terminology. More rigor in designing clinical trials to include sex and gender based analyses and more care in using sex and gender terms in the cancer literature is needed. These efforts are essential to improve the reproducibility, generalizability, and inclusiveness of cancer research.

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肿瘤学临床试验中基于性和性别的分析的评价

背景 本研究的目的是评估在导致监管药物批准的肿瘤学试验中是否使用了基于性别和性别的分析以及适当的性别和性别术语。方法 美国食品药品监督管理局 (FDA) 的血液学/肿瘤学批准和安全通知页面用于识别 2012 年至 2019 年间获得 FDA 批准的所有抗癌疗法。收集了用于支持 FDA 药物批准的试验以及所有可用的补充表格和研究方案。审查文件以确定是否有计划根据性别和性别分析结果，并确定是否使用了一致的性别和性别术语。结果 确定了 128 项随机对照试验，这些试验与获得 FDA 批准的抗癌药物相对应。没有研究具体说明性别和性别是如何收集或分析的。没有研究报告有关参与者性别的任何信息。在 76% (97/128) 的研究中，性和性别术语至少有一次被不一致地使用。在针对非性别特异性癌症部位的 102 项试验中，89% (91/102) 提供了按性别分类的生存结果数据。没有研究提供按性别分类的毒性数据。结论 肿瘤学中的大多数关键临床试验未能说明性和性别之间的重要区别，并将性和性别术语混为一谈。需要更严格地设计临床试验以包括基于性和性别的分析，并且需要更加谨慎地在癌症文献中使用性和性别术语。这些努力对于提高可重复性、普遍性、