Hauck Cherie L, Kelechi Teresa J, Cartmell Kathleen B, Mueller Martina
Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas St., Charleston, SC, 29425, USA.
Clemson University, Department of Public Health Sciences, 503 Edwards Hall, Clemson, SC, 29634, USA.
Contemp Clin Trials Commun. 2021 Oct 21;24:100843. doi: 10.1016/j.conctc.2021.100843. eCollection 2021 Dec.
Cancer is the second-leading cause of death in the United States. Clinical trials translate basic science discoveries into treatments needed by cancer patients. Inadequate accrual of trial participants is one of the most significant barriers to the completion of oncology clinical trials.
The purpose of this study was to investigate trial-level factors that affect accrual and/or completion of oncology clinical trials, identify gaps in the literature, and indicate opportunities for future research.
A systematic review of the literature on trial-level factors that affect accrual and/or completion of oncology clinical trials was performed. Searches in PubMed and Scopus identified 6582 studies. Based on eligibility criteria, 16 studies were selected for the review. Results were analyzed according to the following: a) background factors, b) disease-related, c) treatment-related, and d) trial design.
Background factors that were investigated in relation to oncology clinical trial accrual and/or completion included sponsor, number and location of participating institutions, competing trials, time of trial opening, and fast-track status. Disease-related factors included the annual incidence and type(s) of targeted cancer. Several types of treatment such as drugs, radiation and surgery were examined in the studies. Trial design factors included trial development time, eligibility criteria, randomization, sample size, trial phase, placebo use, and required protocol procedures and their timing.
With low patient participation rates in oncology clinical trials that hold promise for future treatments, it is imperative that trial-level factors affecting accrual be identified and addressed to facilitate the completion of trials.
癌症是美国第二大死因。临床试验将基础科学发现转化为癌症患者所需的治疗方法。试验参与者招募不足是肿瘤学临床试验完成的最重要障碍之一。
本研究的目的是调查影响肿瘤学临床试验招募和/或完成的试验层面因素，识别文献中的空白，并指出未来研究的机会。
对影响肿瘤学临床试验招募和/或完成的试验层面因素的文献进行系统综述。在PubMed和Scopus中检索到6582项研究。根据纳入标准，选择16项研究进行综述。结果根据以下方面进行分析：a）背景因素，b）疾病相关因素，c）治疗相关因素，d）试验设计。
与肿瘤学临床试验招募和/或完成相关的背景因素包括申办者、参与机构的数量和地点、竞争试验、试验启动时间和快速通道状态。疾病相关因素包括目标癌症的年发病率和类型。研究中考察了几种类型的治疗方法，如药物、放疗和手术。试验设计因素包括试验开发时间、纳入标准、随机化、样本量、试验阶段、安慰剂使用以及所需的方案程序及其时间安排。
鉴于有望用于未来治疗的肿瘤学临床试验患者参与率较低，必须识别并解决影响招募的试验层面因素，以促进试验的完成。
