Analyzing and Interpreting PRO-CTCAE with CTCAE and Other Clinical Data to Characterize Drug Tolerability

使用 CTCAE 和其他临床数据分析和解释 PRO-CTCAE，以表征药物耐受性

基本信息

批准号：
10884103
负责人：
ETHAN M. BASCH
金额：
$ 26.92万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-07-08 至 2024-08-31
项目状态：
已结题

项目摘要

PROJECT ABSTRACT In cancer clinical trials, it is essential to understand and communicate the negative impact of drugs on patient participants in order to balance risks and benefits. Symptom side effects such as nausea and diarrhea are particularly common and impactful on the patient experience. However, historically this information has been reported by clinicians on behalf of their patients rather than by patients themselves – a process that has been shown to miss up to half of patients' symptoms. Therefore, the National Cancer Institute (NCI) supported development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), a library of questions to enable systematic patient self-reporting of side effect information. To date, the PRO-CTCAE questions have been developed and tested for validity and feasibility of use in clinical trials – work that was led by the investigators on this proposal under contracts to the NCI. However, it is not yet established how best to combine PRO-CTCAE information with traditional measures of treatment impact such as clinician-reported adverse events, time on treatment, drug dose levels, performance status, and hospitalizations. The purpose of this supplement is to complete work towards understanding the role of the PRO-CTCAE in combination with these traditional measures of treatment impact in assessments of drug tolerability. In this supplement, advanced statistical methods will be used to analyze data from newly available clinical trials, delayed by the pandemic, accessible to the team through the National Clinical Trial Network (cooperative groups) and industry. The specific aims are to: 1) characterize relationships between the PRO-CTCAE and traditional measures of treatment impact and tolerability; 2) test and standardize analytic techniques for the PRO-CTCAE; 3) refine approaches to analyzing missing PRO-CTCAE data; and 4) develop and refine tabular and graphical data visualizations for longitudinal PRO-CTCAE data. To accomplish these aims, our multi-disciplinary team will work collaboratively and flexibly with other investigators and stakeholders through the U01 consortium chaired by Dr. Amylou Dueck, and will continue to share data, statistical programming code, and ideas freely. This work is intended to inform best practices for tabulating and reporting PRO-CTCAE data, and will enable more systematic and patient-centered evaluations of tolerability in cancer clinical trials. This supplement will extend the grant by 12 months.

项目摘要在癌症临床试验中，了解和传达药物对患者的负面影响至关重要参与者为了平衡风险和收益而出现恶心和腹泻等副作用。然而，从历史上看，这些信息一直是常见且对患者体验有影响的。由主教代表患者而非患者本人报告——这一过程已被证实结果显示，该方法可以漏掉多达一半的患者症状，因此，美国国家癌症研究所 (NCI) 表示支持。制定不良反应通用术语标准的患者报告结果版本事件 (PRO-CTCAE)，一个问题库，使患者能够系统地自我报告副作用迄今为止，PRO-CTCAE 问题已经开发并测试了其有效性和可行性。临床试验中的使用——由研究人员根据与 NCI 签订的合同就该提案领导的工作。然而，目前尚未确定如何最好地将 PRO-CTCAE 信息与传统的测量方法结合起来。治疗影响，例如临床医生报告的不良事件、治疗时间、药物剂量水平、表现本补充的目的是完成了解病情的工作。 PRO-CTCAE 与这些治疗影响的传统衡量标准相结合在评估中的作用在本补充品中，将使用先进的统计方法来分析数据。新近可用的临床试验因大流行而推迟，团队可以通过国家临床试验网络（合作团体）和行业的具体目标是： 1）表征。 PRO-CTCAE 与治疗影响和耐受性的传统衡量标准之间的关系 2) 测试并标准化 PRO-CTCAE 的分析技术 3) 完善分析缺失的方法； PRO-CTCAE 数据；4) 开发和完善纵向的表格和图形数据可视化为了实现这些目标，我们的多学科团队将通力合作，通过 Amylou Dueck 博士主持的 U01 联盟与其他研究人员和利益相关者灵活合作，并将继续自由地分享数据、统计编程代码和想法。这项工作的目的是。为制表和报告 PRO-CTCAE 数据的最佳实践提供信息，并将实现更加系统化以及以患者为中心的癌症临床试验耐受性评估。该补充将扩大资助范围。到 12 个月。