Izarn F, Henry J, Besle S, Ray-Coquard I, Blay J-Y, Allignet B
Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
Department of Human and Social Sciences, Triangle, UMR 5206, ENS de Lyon, Lyon, France.
ESMO Open. 2025 Jan;10(1):104086. doi: 10.1016/j.esmoop.2024.104086. Epub 2024 Dec 18.
Over the past two decades, the globalization of oncology clinical trials has expanded, yet significant disparities persist across countries. This study aimed to evaluate these geographical inequalities, the evolution of trial phases, and the adherence to ethical standards according to the World Bank's income group.
The ClinicalTrials.gov database was searched and recorded in June 2024. We analyzed data from 87 748 oncology clinical trials conducted between 2000 and 2021, across high-income (HICs), upper-middle-income (UMICs), lower-middle-income (LMICs), and low-income countries. Key metrics included trial density, funding sources, registration timing, and trial phase distribution.
The number of oncology trials increased significantly, with a mean absolute annual rise of 266.6 trials, with China currently being the leading site of early- and validation-phase trials. While HICs still present the highest trial densities, UMICs showed a notable increase in early-phase trials, reflecting a shift in research dynamics. However, despite these advances, 76.4% of countries still had no new trials initiated by 2024. Additionally, ethical practices saw improvement from 2005 to 2021 with an increase in pre-commencement registration (from 9.2% to 58%, P < 0.0001), and more validation-phase trials with a survival variable as the primary outcome (from 40% to 59.6%, P < 0.0001).
Despite the growth in oncology clinical trials, significant disparities in trial distribution and access remain, especially in LMICs. Continued investments in research infrastructure and adherence to ethical standards are crucial to ensure that clinical research benefits are equitably distributed, particularly in regions with the greatest need for advanced cancer therapies.
在过去二十年中，肿瘤学临床试验的全球化有所扩展，但各国之间仍存在显著差异。本研究旨在根据世界银行的收入组别评估这些地理不平等、试验阶段的演变以及对伦理标准的遵守情况。
检索并记录了2024年6月的ClinicalTrials.gov数据库。我们分析了2000年至2021年间在高收入国家（HICs）、中高收入国家（UMICs）、中低收入国家（LMICs）和低收入国家进行的87748项肿瘤学临床试验的数据。关键指标包括试验密度、资金来源、注册时间和试验阶段分布。
肿瘤学试验数量显著增加，平均每年绝对增加266.6项试验，中国目前是早期和验证阶段试验的主要开展地。虽然高收入国家的试验密度仍然最高，但中高收入国家的早期试验数量显著增加，反映出研究动态的转变。然而，尽管有这些进展，到2024年仍有76.4%的国家没有启动新的试验。此外，从2005年到2021年，伦理实践有所改善，开始前注册有所增加（从9.2%增至58%，P<0.0001），更多以生存变量作为主要结局的验证阶段试验（从40%增至59.6%，P<0.0001）。
尽管肿瘤学临床试验有所增长，但试验分布和可及性方面仍存在显著差异，尤其是在中低收入国家。持续投资于研究基础设施并遵守伦理标准对于确保临床研究益处得到公平分配至关重要，特别是在最需要先进癌症治疗的地区。
