Nanton Veronica, Bryan Richard T, Pope Anne M, Hughes Ana, Jefferson Kieran, Catto James W F, Knight Allen, Gallagher Jean, Mintz Harriet Paige, Pirrie Sarah J, Liu Wenyu, Young Annie, Patel Prashant, James Nicholas D
Health Sciences, University of Warwick Warwick Medical School, Coventry, UK.
Bladder Cancer Research Centre, Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.
BMJ Oncol. 2023 Nov 20;2(1):e000092. doi: 10.1136/bmjonc-2023-000092. eCollection 2023.
Recruitment and retention in cancer trials are long-standing issues, exacerbated by the COVID-19 pandemic. The UK National Institute of Health Research and leading clinicians have emphasised the urgency to achieve and surpass prepandemic levels of participation. Data from a recent UK trial demonstrated the impact of COVID-19 and highlighted factors that limited recruitment. In response to this worldwide problem, studies have identified strategies for remediation at the levels of funding, the research environment, study design and trial team-related aspects, yet evidence of progress is lacking. Equality, diversity and inclusivity have become central to UK health and social policy during the 2000s. The need for greater inclusivity in trials has become a particular concern for cancer researchers and funders in the UK and in the USA, in recognition of potential bias in results. In the UK trials, the lack of standardised recording of ethnicity data renders interpretation difficult and caution is required in comparisons with the USA. Recently, the focus of concern has shifted away from the impact of deprivation and low socioeconomic status on trial participation. Barriers created by these factors and their frequent intersection with ethnicity should not be overlooked. The UK has adopted an advisory approach to broadening recruitment, publishing policy documents, guidance and toolkits. In the USA, by contrast, action on inclusion is increasingly mandated. Within the UK paradigm, the cancer research community is strongly encouraged to adopt a coordinated approach towards standardised digital data collection and embed and evaluate innovative, cocreated, locally relevant strategies.
癌症试验中的招募和受试者留存是长期存在的问题,新冠疫情使这些问题更加恶化。英国国家卫生研究院和顶尖临床医生强调了实现并超越疫情前参与水平的紧迫性。英国近期一项试验的数据显示了新冠疫情的影响,并突出了限制招募的因素。针对这一全球性问题,研究已经确定了在资金、研究环境、研究设计和试验团队相关方面进行补救的策略,但仍缺乏进展的证据。在21世纪,平等、多样性和包容性已成为英国卫生和社会政策的核心。鉴于结果可能存在偏差,试验中需要更大的包容性已成为英国和美国癌症研究人员及资助者特别关注的问题。在英国的试验中,由于缺乏种族数据的标准化记录,难以进行解读,与美国进行比较时需要谨慎。最近,人们关注的焦点已从贫困和低社会经济地位对试验参与的影响上转移。不应忽视这些因素造成的障碍以及它们与种族的频繁交叉。英国采取了一种咨询方式来扩大招募范围,发布了政策文件、指南和工具包。相比之下,美国则越来越多地强制要求采取包容行动。在英国的模式下,强烈鼓励癌症研究界采取协调一致的方法来进行标准化数字数据收集,并采用和评估创新的、共同创建的、与当地相关的策略。