Increasing representation of under-served groups in randomised oncology trials

人们认识到，临床试验中招募的参与者的多样性并不总是代表目标患者人群，如果试验结果有利，将对这些患者采取干预措施。如果我们要确保抢先体验新治疗方案的机会是公平的，并且结果可推广到所有受疾病影响的人，就需要适当代表潜在服务不足的人群。这在肿瘤学中尤其重要，治疗可能会延长，随访可能会很长，两者的影响可能对不同群体产生不同的文化或经济影响。PRioRITy研究1确定了“确保在随机试验中纳入和参与代表性不足或弱势群体的最佳方法是什么？以及“如何优化试验参与者的资格标准，以帮助随机试验的招募？”作为研究重点。ICR-CTSU已建立了一系列随机对照II期和III期癌症试验，包括试验用药品和干预措施（如放疗）。每年有数千名患者参加ICR-CTSU管理的试验，这些试验在英国和国际上的100多家癌症中心和地区医院进行。这为探讨平等、多样性和包容性的特点、与平等、多样性和包容性有关的潜在征聘障碍以及测试干预措施的框架提供了机会，以便更广泛地代表得不到充分服务的人口。ICR-CTSU已就纳入/排除标准及INCLUDE 2种族框架（摘要提交至国际临床试验方法学会议，于二零二二年第三季度发表）审查其试验组合。该研究将建立在这项试点工作的基础上，重点关注癌症治疗的随机试验，并扩展到“隐藏”的人口统计数据。

It is recognised that the diversity of participants enrolling in clinical trials is not always representative of the target population of patients for whom the intervention would be adopted if the trial results are favourable. Appropriate representation of potentially underserved populations is required if we are to ensure that the opportunity for early access to novel treatment options is equitable and results are generalisable to all people affected with the condition. This is particularly critical in oncology, where treatments can be prolonged, follow-up can be lengthy and the impact of both may have different cultural or economic implications for different groups. The PRioRITy study1 identified "what are the best approaches to ensure inclusion and participation of under-represented or vulnerable groups in randomised trials?" and "how can eligibility criteria for trial participants be optimised so that they aid recruitment to randomised trials?" as research priorities. The ICR-CTSU has an established portfolio of randomised controlled phase II and III cancer trials, both of investigational medicinal products and of interventions such as radiotherapy. Several thousand patients are typically enrolled in ICR-CTSU managed trials at over 100 cancer centres and regional hospitals across the UK and internationally each year. This provides an opportunity to explore equality, diversity and inclusion (EDI) characteristics, potential EDI-related barriers to recruitment and a framework for testing interventions for broader representation of underserved populations. ICR-CTSU has reviewed its trial portfolio with respect to inclusion/exclusion criteria and The INCLUDE2 Ethnicity Framework (abstract submitted to International Clinical Trials Methodology Conference for presentation in Q3 2022). The studentship will build on this pilot work with a focus on randomised trials of cancer treatments and extension into "hidden" demographics data.