对早期临床试验中获取实验性治疗机会的差异缺乏调查研究。EGALICAN-2研究的目标是确定造成这种不平等的因素。法国国家癌症研究所认证的11个早期临床试验中心(CLIP2)进行了一项国家前瞻性调查。收集了社会人口学、社会经济和医疗数据。利用单变量逻辑回归模型估计与每个研究变量影响相关的比值比和90%置信区间。构建了一个多元逻辑回归模型，探索与实验性治疗(C1D1)的给药相关的独立因素。进行了剔除女性癌症患者的事后分析。2015年至2016年，法国的11个CLIP2中心共有1355名患者参与了研究。848名患者接受了C1D1治疗(73%)，320名患者(27%)未通过筛选。年龄中位数为58岁(范围17-97岁)，667名患者(54%)为女性。大多数患者患有转移性疾病(n=751, 87%)。在多元逻辑回归分析中，与C1D1相关的显著独立因素是男性、在拥有早期临床试验单位的医院接受初始治疗以及居住在富裕的大都市地区(P值<0.05)。在事后分析中，性别因素不再显著[比值比=1.21 (95%置信区间0.86-1.70)，P值=0.271]。本研究调查了肿瘤学早期临床试验中社会不平等因素。我们的研究强调了性别、治疗路径和地理位置的因素。与乳腺癌不同，妇科癌对C1D1的影响显著。本研究的结果有助于改善患者参与早期临床试验的机会。 版权所有 © 2023 The Authors. 由Elsevier Ltd. 发表。保留所有权利。

Investigation of the disparities in the access to experimental treatment in early-phase clinical trials is lacking. The objective of the EGALICAN-2 study was to identify the factors underpinning such inequalities.A national prospective survey was conducted in 11 early-phase clinical trial centers (CLIP2) certified by the French National Cancer Institute. Sociodemographic, socioeconomic and medical data were collected. Univariate logistic regression models were carried out to estimate odds ratios and 90% confidence intervals associated with the effect of each study variable. A multivariate logistic regression model was built to explore the independent factors associated with the administration of the experimental treatment (C1D1). A post hoc analysis was carried out excluding female cancer patients.Between 2015 and 2016, 1355 patients referred from 11 CLIP2 centers in France were included in the study. Eight hundred and forty-eight patients received C1D1 (73%) and 320 patients (27%) were screening failure. Median age was 58 years (range 17-97 years) and 667 patients (54%) were female. Most patients had a metastatic disease (n = 751, 87%). In the multivariate logistic regression analysis, the significant independent factors associated with C1D1 were male sex, initial care received in a hospital with an early-phase unit and living in wealthy metropolitan areas (P values <0.05). In the post hoc analysis, the sex factor was no longer significant [odds ratio = 1.21 (95% confidence interval 0.86-1.70), P value = 0.271].This study investigated the factors producing social inequalities in the context of early-phase clinical trials in oncology. Our research highlights factors of sex, care pathway and geographic location. Gynecological cancer was found to impact C1D1 significantly, unlike breast cancer. The results of this study should contribute to improve patient access to early-phase clinical trials.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.