CRUK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, 1053 Great Western Road, Glasgow, G12 OYN, UK.
Institute of Health and Wellbeing, University Of Glasgow Gartnavel Royal Hospital, Admin Building, 1st Floor, 1055 Great Western Road, Glasgow,, G12 0XH, UK.
Trials. 2020 Jun 5;21(1):486. doi: 10.1186/s13063-020-04425-9.
An impactful clinical trial will have real-life benefits for patients and society beyond the academic environment. This study analyses case studies of cancer trials to understand how impact is evidenced for cancer trials and how impact evaluation can be more routinely adopted and improved.
The United Kingdom (UK) Government allocates research funding to higher-education institutions based on an assessment of the institutions' previous research efforts, in an exercise known as the Research Excellence Framework (REF). In addition to each institution's journal publications and research environment, for the first time in 2014, allocation of funding was also dependent on an evaluation of the wider, societal impact of research conducted. In the REF2014, impact assessment was performed by evaluation of impact case studies. In this study, case studies (n = 6637) submitted by institutions for the REF2014 were accessed and those focussing on cancer trials were identified. Manual content analysis was then used to assess the characteristics of the cancer trials discussed in the case studies, the impact described and the methods used by institutions to demonstrate impact.
Forty-six case studies describing 106 individual cancer trials were identified. The majority were phase III randomised controlled trials and those recruiting patients with breast cancer. A list of indicators of cancer trial impact was generated using the previous literature and developed inductively using these case studies. The most common impact from a cancer trial identified in the case studies was on policy, in particular citation of trial findings in clinical guidelines. Impact on health outcomes and the economy were less frequent and health outcomes were often predicted rather than evidenced. There were few descriptions identified of trialists making efforts to maximise trial impact.
Cancer trial impact narratives for the next REF assessment exercise in 2021 can be improved by evidencing actual rather than predicted Impact, with a clearer identification of the beneficiaries of cancer trials and the processes through which trial results are used. Clarification of the individuals responsible for performing impact evaluations of cancer trials and the provision of resources to do so needs to be addressed if impact evaluation is to be sustainable.
一项有影响力的临床试验将为患者和社会带来超出学术环境的实际益处。本研究通过分析癌症试验案例研究，了解如何为癌症试验提供证据，并探讨如何更常规地采用和改进影响评估。
英国（UK）政府根据各机构以往的研究工作评估，向高等教育机构分配研究资金，这一过程被称为卓越研究框架（REF）。除了每个机构的期刊出版物和研究环境外，2014 年首次将资金分配还取决于对所进行的研究的更广泛的社会影响的评估。在 REF2014 中，通过评估影响案例研究来进行影响评估。在这项研究中，访问了机构为 REF2014 提交的案例研究（n=6637），并确定了专注于癌症试验的案例研究。然后手动进行内容分析，以评估案例研究中讨论的癌症试验的特征、描述的影响以及机构用于证明影响的方法。
确定了 46 个描述 106 个单独癌症试验的案例研究。大多数是 III 期随机对照试验，招募的是乳腺癌患者。使用先前的文献生成了癌症试验影响的指标列表，并使用这些案例研究进行归纳式开发。案例研究中确定的癌症试验最常见的影响是政策方面，特别是在临床指南中引用试验结果。对健康结果和经济的影响较少见，并且通常是预测而不是证明。很少有描述表明试验人员努力最大限度地提高试验的影响力。
在 2021 年的下一次 REF 评估中，癌症试验影响的叙述可以通过提供实际而非预测的影响来改进，更明确地确定癌症试验的受益者以及使用试验结果的过程。如果要使影响评估可持续，则需要明确负责进行癌症试验影响评估的人员，并提供资源。
