Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
Queen's University, Kingston, Ontario, Canada.
Int J Radiat Oncol Biol Phys. 2022 Jul 1;113(3):500-508. doi: 10.1016/j.ijrobp.2022.01.053. Epub 2022 Feb 11.
Randomized controlled trials (RCTs) are the cornerstone of delivering sustained improvements in cancer outcome. To inform radiation therapy research policy and prioritization, we analyze the radiation therapy RCT landscape including comparison with trials of systemic therapies over the same period, with a specific focus on funding and disparities across income settings.
This retrospective cohort study identified all phase 3 RCTs evaluating anticancer therapies published from 2014 to 2017. RCTs were classified according to anticancer modality and country of origin. Descriptive statistics were used to compare key characteristics of radiation therapy RCT studies according to study design characteristics, tumor types evaluated, types of intervention appraised, treatment intent and main funding sources.
The study cohort included 694 RCTs of which 64 were radiation therapy RCTs (9%) compared with 601 systemic therapy RCTs (87%). Among all radiation therapy RCTs, 47% of them focused on 2 areas of evaluation: (1) combining radiation therapy with systemic agents (25%) and (2) changes in dose fractionation (22%). The most common cancers studied were head and neck (22%), lung (22%), and breast (14%), with cervical cancer trials representing only 3% of the cohort. Among the radiation therapy RCTs, 33% of them met their primary endpoint, and 62% assessed interventions in the curative setting compared with 31% in systemic therapy RCTs. For their country locations, 77% of radiation therapy RCTs took place in high-income countries, 13% in low-and-middle-income countries, and 11% in both high-income and low-and-middle-income countries. For funding, 17% of radiation therapy RCTs received funding from industry compared with 79% of systemic therapy RCTs.
This study highlights the need for greater investment in radiation therapy RCTs and the need to look at the disparities in conducting RCTs globally. The study emphases the urgent need for more capacity building for cancer clinical trials in low-and-middle-income countries and more sustainable funding sources.
随机对照试验（RCT）是持续改善癌症结果的基石。为了为放射治疗研究政策和优先级提供信息，我们分析了放射治疗 RCT 领域，包括与同期系统治疗试验的比较，并特别关注收入环境下的资金和差异。
这项回顾性队列研究确定了所有评估抗癌疗法的 3 期 RCT，这些 RCT 发表于 2014 年至 2017 年期间。根据抗癌模式和原产国对 RCT 进行分类。使用描述性统计来比较放射治疗 RCT 研究根据研究设计特征、评估的肿瘤类型、评估的干预类型、治疗意图和主要资金来源的关键特征。
该研究队列包括 694 项 RCT，其中 64 项为放射治疗 RCT（9%），601 项为系统治疗 RCT（87%）。在所有放射治疗 RCT 中，有 47%的研究集中在 2 个评估领域：（1）将放射治疗与全身药物联合使用（25%）和（2）改变剂量分割（22%）。研究最多的癌症是头颈部（22%）、肺部（22%）和乳房（14%），而宫颈癌试验仅占队列的 3%。在放射治疗 RCT 中，有 33%的研究达到了主要终点，62%的研究评估了根治性干预措施，而系统治疗 RCT 中这一比例为 31%。就其国家位置而言，77%的放射治疗 RCT 发生在高收入国家，13%发生在中低收入国家，11%发生在高收入和中低收入国家。在资金方面，17%的放射治疗 RCT 得到了工业界的资助，而 79%的系统治疗 RCT 得到了资助。
本研究强调了需要增加对放射治疗 RCT 的投资，并需要研究全球范围内进行 RCT 的差异。该研究强调了在中低收入国家进行癌症临床试验的能力建设和更可持续的资金来源的迫切需要。
