乳腺癌临床试验中对种族和民族报道不足。
Insufficient Reporting of Race and Ethnicity in Breast Cancer Clinical Trials.
发表日期:2023 Sep 01
作者:
Grace Keegan, Angelena Crown, Charles DiMaggio, Kathie-Ann Joseph
来源:
ANNALS OF SURGICAL ONCOLOGY
摘要:
临床试验出版物中报告种族和种族的重要性不言而喻,这对于确定新治疗方案的普适性和有效性至关重要。这在乳腺癌方面尤为重要,因为研究表明黑人女性的死亡率比其他人高出40%至100%,然而她们在临床试验中的代表性不足。我们的目标是描述乳腺癌试验出版物中关于种族/种族报道的时间变化。我们在ClinicalTrials.gov进行搜索,以确定与从2010年5月至2022年张贴结果的试验相关联的主要出版物。统计分析包括总和频率和随时间变化的报道种族/种族比例和非白人受试者比例的线性回归模型。符合纳入标准的98项研究中有72项(73.4%)报告了种族/种族。在将报道种族/种族作为时间函数的线性回归模型中,未发现统计学上的显著变化,但我们检测到一个朝向减少趋势的信号(季度系数为-2.2,p = 0.2)。在整个研究期间报告种族和种族数据的所有研究中,非白人受试者的整体百分比为21.9%(标准误差为1.8,95%置信区间为18.4,25.5),出现了非白人入组比例减少的趋势(年季度系数为-0.8,p = 0.2)。我们的数据显示,在过去的12年中,乳腺癌临床试验中的种族报告和少数族裔群体的整体代表性没有改善,甚至可能有所下降。增加种族和种族数据的报告迫使医学界面对临床试验获取的不平等进行反思。这可能改善吸纳和留住少数族裔群体参与临床试验的努力,并随着时间的推移,减少肿瘤治疗结果的种族差异。© 2023. Society of Surgical Oncology.
Reporting race and ethnicity in clinical trial publications is critical for determining the generalizability and effectiveness of new treatments. This is particularly important for breast cancer, in which Black women have been shown to have between 40 and 100% higher mortality rate yet are underrepresented in trials. Our objective was to describe changes over time in the reporting of race/ethnicity in breast trial publications.We searched ClinicalTrials.gov to identify the primary publication linked to trials with results posted from May 2010-2022. Statistical analysis included summed frequencies and a linear regression model of the proportion of articles reporting race/ethnicity and the proportion of non-White enrollees over time.A proportion of 72 of the 98 (73.4%) studies that met inclusion criteria reported race/ethnicity. In a linear regression model of the proportion of studies reporting race/ethnicity as a function of time, there was no statistically significant change, although we detected a signal toward a decreasing trend (coefficient for quarter = -2.2, p = 0.2). Among all studies reporting race and ethnicity over the study period, the overall percentage of non-White enrollees during the study period was 21.9%, [standard error (s.e.) 1.8, 95% confidence interval (CI) 18.4, 25.5] with a signal towards a decreasing trend in Non-White enrollment [coefficient for year-quarter = -0.8 (p = 0.2)].Our data demonstrate that both race reporting and overall representation of minority groups in breast cancer clinical trials did not improve over the last 12 years and may have, in fact, decreased. Increased reporting of race and ethnicity data forces the medical community to confront disparities in access to clinical trials. This may improve efforts to recruit and retain members of minority groups in clinical trials, and over time, reduce racial disparities in oncologic outcomes.© 2023. Society of Surgical Oncology.