Donnelly Conan B, Wotherspoon Amy C, Morris Melanie, Wilson Richard H, Chen Jingwen J, Cairnduff Victoria, Morgan Eileen, Devlin Amy, Gavin Anna T
aNorthern Ireland Cancer Registry bCentre for Public Health cSchool of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast dNI Cancer Trials Centre and NI Cancer Trials Network, Belfast City Hospital, Belfast, UK.
Eur J Cancer Prev. 2017 Sep;26 Joining forces for better cancer registration in Europe:S229-S235. doi: 10.1097/CEJ.0000000000000373.
The aim of this study was to document cancer trial participation since establishment of the Northern Ireland Cancer Trials Network and investigate population and disease factors associated with trial participation. An independent cohort of over 51 000 cancer patients from the Northern Ireland Cancer Registry covering the same population (2007-2012) was linked to a database of 1316 interventional cancer trial participants in a UK region. The primary outcome measure was participation in an intervention clinical trial. Patients were followed up until 31 March 2013. Kaplan-Meier tests and Cox proportional hazard models using person days at risk to allow for death were used to investigate factors associated with trial participation. Multivariate analysis assessed the impact of age, cancer type and stage, distance from the cancer centre (radiotherapy), marital status, deprivation quintile and rurality. Participation was analysed separately for children (<15 years) and young individuals (15-24 years). Trial recruitment increased three-fold with establishment of a network. Participation was the highest for children at 21%, but relatively low at 2.05% for adults, although higher for haematological malignancies (4.5%). Lower likelihood of trial participation in adults was associated with female sex, older age, distance from regional Cancer Centre and stage 1 disease. The introduction of a regional Cancer Trials Network was associated with increased participation; however, trial participation remains relatively low at the population level especially among elderly patients. Linkage of clinical trials and cancer registry database provide an easy mechanism to monitor trial representativeness at the population level.
本研究的目的是记录自北爱尔兰癌症试验网络建立以来癌症试验的参与情况,并调查与试验参与相关的人群和疾病因素。来自北爱尔兰癌症登记处的一个独立队列,涵盖了同一人群(2007 - 2012年)的51000多名癌症患者,与英国一个地区的1316名介入性癌症试验参与者的数据库相链接。主要结局指标是参与干预性临床试验。对患者进行随访至2013年3月31日。使用Kaplan - Meier检验和Cox比例风险模型,以允许死亡的风险人天数来研究与试验参与相关的因素。多变量分析评估了年龄、癌症类型和分期、与癌症中心的距离(放疗)、婚姻状况、贫困五分位数和农村地区等因素的影响。分别对儿童(<15岁)和年轻人(15 - 24岁)的参与情况进行了分析。随着网络的建立,试验招募增加了两倍。儿童的参与率最高,为21%,而成人的参与率相对较低,为2.05%,尽管血液系统恶性肿瘤的参与率较高(4.5%)。成人试验参与可能性较低与女性、年龄较大、与地区癌症中心的距离以及1期疾病有关。区域癌症试验网络的引入与参与率的提高有关;然而,在人群层面,试验参与率仍然相对较低,尤其是在老年患者中。临床试验与癌症登记数据库的链接提供了一种在人群层面监测试验代表性的简便机制。