Division of Medical Oncology, University of Colorado Hospital, Aurora, CO 80045, USA.
Division of Oncology, Siteman Cancer Center, Washington University in St. Louis, MO 63110, USA.
Future Oncol. 2021 Aug;17(24):3271-3280. doi: 10.2217/fon-2020-1262. Epub 2021 May 28.
To provide an assessment of published literature on the demographic representation in Phase I trials of biopharmaceutical oncology agents. We conducted a rapid evidence assessment to identify demographic representation reported in Phase I clinical trials for biopharmaceutical oncology agents published in 2019. Globally, the population was predominantly White/Caucasian (62.2%). In the USA, the distribution was heavily skewed toward White/Caucasian (84.2%), with minimal representation of Blacks/African-Americans (7.3%), Asians (3.4%), Hispanics/Latinos (2.8%) or other race/ethnicity groups. Our data highlight that Phase I oncology trials do not reflect the population at large, which may perpetuate health disparities. Further research is needed to understand and address barriers to participation, particularly among under-represented groups.
评估生物制药肿瘤学药物 I 期试验中的人群代表性文献。我们进行了快速证据评估，以确定 2019 年发表的生物制药肿瘤学药物 I 期临床试验中报告的人口统计学代表性。在全球范围内，人群主要为白种人/高加索人（62.2%）。在美国，分布严重偏向白种人/高加索人（84.2%），黑人/非裔美国人（7.3%）、亚洲人（3.4%）、西班牙裔/拉丁裔（2.8%）或其他种族/民族群体的代表性极小。我们的数据表明，I 期肿瘤学试验不能反映总体人群，这可能会延续健康差距。需要进一步研究以了解和解决参与障碍，特别是在代表性不足的群体中。
