Fortrea Inc., Durham, USA.
SAMRC Precision Oncology Research Unit (PORU), DSI/NRF SARChI Chair in Precision Oncology and Cancer Prevention (POCP), Pan African Cancer Research Institute (PACRI), University of Pretoria, Pretoria, South Africa.
ESMO Open. 2024 May;9(5):103373. doi: 10.1016/j.esmoop.2024.103373. Epub 2024 May 7.
The burden of cancer exerts a disproportionate impact across different regions and population subsets. Disease-specific attributes, coupled with genetic and socioeconomic factors, significantly influence cancer treatment outcomes. Precision oncology promises the development of safe and effective options for specific ethnic phenotypes and clinicodemographic profiles. Currently, clinical trials are concentrated in resource-rich geographies with younger, healthier, white, educated, and empowered populations. Vulnerable and marginalized people are often deprived of opportunities to participate in clinical trials. Despite consistent endeavors by regulators, industry, and other stakeholders, factors including diversity in trial regulations and patient and provider-related cultural, logistic, and operational barriers limit the inclusiveness of clinical trials. Understanding and addressing these constraints by collaborative actions involving regulatory initiatives, industry, patient advocacy groups, community engagement in a culturally sensitive manner, and designing and promoting decentralized clinical trials are vital to establishing a clinical research ecosystem that promotes equity in the representation of population subgroups.
癌症负担在不同地区和人群亚组中存在不成比例的影响。疾病的特定属性，加上遗传和社会经济因素，会极大地影响癌症治疗的结果。精准肿瘤学有望为特定的种族表型和临床人口统计学特征开发安全有效的治疗选择。目前，临床试验主要集中在资源丰富的地区，这些地区的人群往往更加年轻、健康、白种人、受过教育和有能力。弱势群体和边缘人群往往被剥夺了参与临床试验的机会。尽管监管机构、行业和其他利益相关者一直在努力，但包括试验法规多样性以及患者和提供者相关的文化、后勤和运营障碍在内的因素，限制了临床试验的包容性。通过涉及监管举措、行业、患者权益组织、以文化敏感方式进行社区参与以及设计和推广分散临床试验的协作行动来理解和应对这些限制，对于建立一个促进人口亚组代表性公平的临床研究生态系统至关重要。
