Clinical outcome assessment trends in clinical trials-Contrasting oncology and non-oncology trials.
Clinical outcome assessment trends in clinical trials-Contrasting oncology and non-oncology trials.
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DOI：
10.1002/cam4.6325
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发表时间：
2023-08
期刊：
影响因子：
4
通讯作者：
Celiku O
中科院分区：
文献类型：
--
作者：
Kim Y;Gilbert MR;Armstrong TS;Celiku O
临床结果评估(COA)是以患者为中心的新干预措施和支持性护理评估的关键。COA在肿瘤学中尤其信息丰富，在肿瘤学中，关注患者的感觉和功能是至高无上的，但它们在试验结果中的纳入落后于传统的生存和肿瘤反应。为了了解COA在肿瘤学中的使用趋势以及促进COA使用的里程碑式努力的影响，我们在ClinicalTrials.gov上对肿瘤学临床试验进行了计算调查，并将它们与临床研究的其余部分进行了比较。肿瘤学试验是通过以肿瘤术语为标题的医学受试者确定的。试验检索从PROQOLID获得的COA器械名称。回归分析评估了与时间和设计相关的趋势。在1985年至2020年启动的肿瘤学介入试验中，有18%(N = 35,415)报告使用了655台COA器械中的一种或多种。84%的使用COA的试验利用了患者报告的结果，其中4%-27%使用了其他COA类别的试验。使用COA的可能性随着试验阶段的进展(OR = 1.30，p <； 0.001)、随机化(OR = 2.32，p <； 0.001)、数据监测委员会的使用(OR = 1.26，p <； 0.001)、非FDA管制干预研究(OR = 1.23，p = 0.001)、支持性护理与治疗为重点的试验(OR = 2.94，p <； 0.001)而增加。在1985年至2020年启动的非肿瘤学试验中(N = 244,440)，有26%的人报告使用辅酶A；它们具有与肿瘤学试验相似的辅酶A使用预测因素。CoA的使用量随着时间的推移呈线性增长(R = 0.98p <； 0.001)，在几个单独的监管事件之后显著增加。虽然COA在临床研究中的使用量随着时间的推移而增加，但仍有必要进一步推广COA的使用，特别是在早期和以治疗为重点的肿瘤学试验中。在ClinicalTrials.gov登记中对介入临床试验的综合评估显示，肿瘤试验中纳入临床结果评估的比率很低，但正在增加。虽然这项研究揭示了监管和倡导努力对更多地使用临床结果评估的积极影响，但仍有必要进一步瞄准早期和以治疗为重点的肿瘤学试验。
Clinical outcome assessments (COAs) are key to patient‐centered evaluation of novel interventions and supportive care. COAs are particularly informative in oncology where a focus on how patients feel and function is paramount, but their incorporation in trial outcomes have lagged that of traditional survival and tumor responses. To understand the trends of COA use in oncology and the impact of landmark efforts to promote COA use, we computationally surveyed oncology clinical trials in ClinicalTrials.gov comparing them to the rest of the clinical research landscape. Oncology trials were identified using medical subject heading neoplasm terms. Trials were searched for COA instrument names obtained from PROQOLID. Regression analyses assessed chronological and design‐related trends. Eighteen percent of oncology interventional trials initiated 1985–2020 (N = 35,415) reported using one or more of 655 COA instruments. Eighty‐four percent of the COA‐using trials utilized patient‐reported outcomes, with other COA categories used in 4–27% of these trials. Likelihood of COA use increased with progressing trial phase (OR = 1.30, p < 0.001), randomization (OR = 2.32, p < 0.001), use of data monitoring committees (OR = 1.26, p < 0.001), study of non‐FDA‐regulated interventions (OR = 1.23, p = 0.001), and in supportive care versus treatment‐focused trials (OR = 2.94, p < 0.001). Twenty‐six percent of non‐oncology trials initiated 1985–2020 (N = 244,440) reported COA use; they had similar COA‐use predictive factors as oncology trials. COA use increased linearly over time (R = 0.98, p < 0.001), with significant increases following several individual regulatory events. While COA use across clinical research has increased over time, there remains a need to further promote COA use particularly in early phase and treatment‐focused oncology trials. Comprehensive evaluation of interventional clinical trials in the ClinicalTrials.gov registry revealed low but increasing rates of clinical outcome assessment incorporation in oncology trials. While the study revealed a positive impact of regulatory and advocacy efforts on increasing use of clinical outcome assessments, there remains a need to further target early phase and treatment‐focused oncology trials.
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