Agaronnik Nicole D, Peters Mary Linton B, Iezzoni Lisa I
Harvard Medical School, Boston, MA, USA.
Division of Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Clin Trials. 2025 Jun;22(3):367-373. doi: 10.1177/17407745241304114. Epub 2025 Jan 2.
BACKGROUND/AIMS: People with disability have higher rates of cancer, excluding skin cancer, compared with people without disability. Food and Drug Administration draft guidelines from 2024 address use of performance status criteria to determine eligibility for clinical trials, advocating for less restrictive thresholds. We examined the exclusion of people with disability from clinical trials based on performance status and other criteria.
We reviewed eligibility criteria in approved interventional Phase III and Phase IV oncology clinical trials listed on ClinicalTrails.gov between 1 January 2019 and 31 December 2023. Functional status thresholds were assessed using the Eastern Cooperative Oncology Group Performance Status Scale and Karnofsky Performance Scale in clinical trial eligibility criteria. Qualitative analysis was used to review eligibility criteria relating to functional impairments or disability.
Among 96 oncology clinical trials, approximately 40% had restrictive Eastern Cooperative Oncology Group and Karnofsky Performance Scale thresholds, explicitly including only patients with Eastern Cooperative Oncology Group 0 or 1, or equivalent Karnofsky Performance Scale 70 or greater. Only 20% of studies included patients with Eastern Cooperative Oncology Group 2 and Karnofsky Performance Scale 60. Multiple studies contained miscellaneous eligibility criteria that could potentially exclude people with disability. No studies described making accommodations for people with disability to participate in the clinical trial.
Draft Food and Drug Administration guidelines recommend including patients with Eastern Cooperative Oncology Group scores of 2 and Karnofsky Performance Scale scores of 60 in oncology clinical trials. We found that oncology clinical trials often exclude people with more restrictive performance status scores than the draft Food and Drug Administration guidelines, as well as other criteria that relate to disability. These estimates provide baseline information for assessing how the 2024 Food and Drug Administration guidance, if finalized, might affect the inclusion of people with disability in future trials.
背景/目的：与非残疾人士相比，残疾人士患癌症（不包括皮肤癌）的几率更高。美国食品药品监督管理局2024年的指南草案涉及使用体能状态标准来确定临床试验的资格，主张采用限制较少的阈值。我们基于体能状态和其他标准研究了残疾人士被排除在临床试验之外的情况。
我们回顾了2019年1月1日至2023年12月31日期间在ClinicalTrails.gov上列出的已批准的介入性III期和IV期肿瘤学临床试验的资格标准。在临床试验资格标准中，使用东部肿瘤协作组体能状态量表和卡氏功能状态量表评估功能状态阈值。采用定性分析来审查与功能障碍或残疾相关的资格标准。
在96项肿瘤学临床试验中，约40%的试验对东部肿瘤协作组和卡氏功能状态量表设定了严格的阈值，明确仅纳入东部肿瘤协作组0或1级的患者，或卡氏功能状态量表评分70分及以上的等效患者。只有20%的研究纳入了东部肿瘤协作组2级和卡氏功能状态量表60分的患者。多项研究包含可能会将残疾人士排除在外的其他资格标准。没有研究描述为残疾人士参与临床试验提供便利。
美国食品药品监督管理局的指南草案建议在肿瘤学临床试验中纳入东部肿瘤协作组评分为2分、卡氏功能状态量表评分为60分的患者。我们发现，肿瘤学临床试验通常排除了比美国食品药品监督管理局指南草案中体能状态评分更严格的残疾人士，以及与残疾相关的其他标准。这些评估为评估2024年美国食品药品监督管理局的指南（如果最终确定）如何影响未来试验中残疾人士的纳入提供了基线信息。
