Global Distribution and Characteristics of Research Facilities Participating in Phase III Oncology Trials.
完整摘要 · 中文译文
背景：III期临床试验为患者提供了获得新兴疗法的机会，但地理可及性差异显著。开展此类试验的研究机构的分布特征可为了解全球不均衡提供线索。 方法：我们于2024年7月23日从ClinicalTrials.gov数据库中提取了所有正在招募的III期癌症干预性试验内的研究站点。将地址各组成部分合并后通过谷歌地图API（Google Maps API）进行查询以实现标准化识别。我们比较了世界银行各区域内研究机构的数量、密度（每100万人）及试验组合，并使用双对数线性模型估计了各国试验与研究机构的弹性系数[β]。 结果：在来自1287项试验的77625个列出站点中，64018个（82.5%）被映射至84个国家的6634个唯一研究机构。各国研究机构数量与试验数量呈强相关（R2 = 0.86，p值 < 0.001，β = 0.95，95% CI 0.87-1.04）。美国和中国的机构数量（2626，39.6%）和试验数量（624，48.5%）分别最多。规模最大的100家研究机构来自高收入国家（HIC）或中国，密度排名前20的国家中有16个（80%）位于欧洲和中亚。拉丁美洲和加勒比、南亚及撒哈拉以南非洲地区仅开展多区域试验（> 93%，p值 < 0.001）、企业申办试验（> 90%，p值 < 0.001）和全身治疗试验（> 80%，p值 < 0.001）的机构比例较高。 结论：研究机构的数量为 与各国癌症试验的数量密切相关。在高收入国家（HICs）之外，研究机构数量较少，主要集中于全身治疗，并且经常依赖于产业资助的多区域试验。
完整摘要 · 英文原文
BACKGROUND: Phase III clinical trials offer patients access to emerging therapies, yet geographical access varies significantly. The profile of research facilities conducting such trials can provide insights into global disparities. METHODS: We extracted all research sites within recruiting Phase III cancer interventional trials from the ClinicalTrials.gov database on July 23, 2024. Address components were combined and queried through the Google Maps API for standardized identification. We compared research facilities' number, density (per 1 M people), and portfolio of trials across World Bank regions and estimated the elasticity coefficient [β] of trials and research facilities per country with log-log linear models. RESULTS: Of 77,625 listed sites from 1287 trials, 64,018 (82.5%) were mapped to 6634 unique research facilities across 84 countries. The number of research facilities and trials by country were strongly correlated (R2 = 0.86, p value < 0.001, β = 0.95, 95% CI 0.87-1.04). The United States and China had the largest number of facilities (2626, 39.6%) and trials (624, 48.5%) respectively. The 100 largest research facilities in size were from high-income countries (HIC) or China, and 16/20 (80%) top countries by density were located in Europe and Central Asia. Latin America and Caribbean, South Asia, and Sub-Saharan Africa had high proportion of facilities running exclusively multiregional (> 93%, p value < 0.001), industry-sponsored (> 90%, p value < 0.001), and systemic therapy trials (> 80%, p value < 0.001). CONCLUSIONS: The number of research facilities is strongly associated with the volume of cancer trials across countries. Outside HICs, research facilities were less numerous, focused on systemic therapies, and frequently reliant on industry-sponsored, multiregional trials.
摘要 待译
BACKGROUND: Phase III clinical trials offer patients access to emerging therapies, yet geographical access varies significantly. The profile of research facilities conducting such trials can provide insights into global disparities. METHODS: We extracted all research sites within recruiting Phase III cancer interventional trials from the ClinicalTrials.gov database on July 23, 2024. Address components were combined and queried through the Google Maps API for standardized identification.…