Advancing Analysis and Interpretation ofAdverse Events and PROs in Cancer Clinical Trials
推进癌症临床试验中不良事件和 PRO 的分析和解释
基本信息
- 批准号:10477392
- 负责人:
- 金额:$ 65.03万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-09-19 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AccountingAddressAdjuvant TherapyAdverse eventAdvocateAftercareAlkaline PhosphataseBilirubinCharacteristicsChemopreventionClinical InvestigatorClinical TrialsClinical assessmentsCollaborationsCommon Terminology Criteria for Adverse EventsCommunitiesDataData AnalysesData CollectionData ReportingData ScientistDevelopmentDiseaseDoseDose-LimitingEvaluationEventFrequenciesFundingFutureGenerationsHuman ResourcesImmunotherapyMeasuresMethodsModelingMorbidity - disease rateNational Surgical Adjuvant Breast and Bowel ProjectOncologistOncologyOutcomePatient Outcomes AssessmentsPatientsPhasePhase III Clinical TrialsPsychometricsPublishingRandomizedReportingResearchResearch PersonnelResourcesRisk FactorsSerumStandardizationStatistical MethodsTherapy trialTimeToxic effectTreatment-related toxicityVoiceWorkbasecancer clinical trialcancer sitecancer therapydata managementdocetaxelexperiencehealth related quality of lifeimmunotherapy trialsimprovedindexingindividual patientinstrumentirinotecanmultidisciplinarynovelnovel strategiespatient populationpredictive modelingprogramssecondary outcomestatistical centertreatment sitetreatment trialweb app
项目摘要
In this application and program of research, we will collaborate with the NRG Oncology Statistical Center to
develop analytic strategies to investigate novel methods for assessing treatment tolerability, as well as to model
new approaches for data presentation using data from randomized NSABP trials that contain both Common
Terminology Criteria for Adverse Events (CTCAE) data and high quality patient reported outcomes (PRO) data.
Subsequently, we will apply these new analytic approaches and other methods to NRG Oncology phase III
clinical trials that include PRO-CTCAE items to assess treatment toxicity associated with immunotherapy.
Inclusion of PRO-CTCAE items in this newest generation of immunotherapy trials is particularly important, as
there are limited PRO data from early phase immunotherapy studies, and tolerability may be a critical issue for
patients in the adjuvant therapy or early metastatic disease settings that are the patient populations in these
trials. We previously developed a summary measure, the toxicity index (TI), to discriminate patients based on
their overall toxicity experiences. Toxicity data are summarized for each subject from graded AE according to
CTCAE. TI accounts for all observed toxicity grades rather than only the most severe one, as is conventionally
done. Because of its sensitivity to differences in the overall toxicity, the TI is likely to be useful also for identifying
predictors of treatment-related toxicity. In addition to the other novel methods described herein, we will employ
the TI and extensions or refinements of it to support new and improved methods for PRO and related adverse
event data. The problems addressed in this RFA are very amenable to partial solution by the TI approach. We
also propose to modify it in collaboration with oncologists, PRO experts and patient advocates to address the
duration and frequency of AEs, and other special needs of PRO-CTCAE data. While we will focus much effort
on developing new technical statistical methods, we will work as a team of PRO experts, oncologists, data
scientists, and clinical trial experts to keep the developments grounded in patient-centric and clinical trial relevant
perspectives. The specific aims of this application are: Aim 1: To apply and extend TI and other methods to
describe toxicity and develop models to determine risk factors for AEs. (a) Develop new graphical methods to
describe toxicity; (b) Develop new longitudinal models accounting for missing data to determine risk factors for
AEs; (c) Compare our new methods with existing approaches such as max-grade/max-time, TAME, and ToxT;
(d) Refine, extend, and apply the TI to PRO-CTCAE to model CTCAE data. Aim 2: To develop predictive models
for limiting dose toxicity, treatment completion, and efficacy based on individual patient characteristics and
toxicity profiles defined by TI and PRO-TI. (a) Develop predictive models for completion and efficacy as time to
event outcomes; (b) Develop predictive models for optimal dose using various definitions of tolerability based on
CTCAE and PRO-CTCAE; (c) Develop and disseminate web applications to implement the methods developed;
(d) Use multi-disciplinary experts and patient advocates to review and guide the methods developed.
在此应用程序和研究计划中,我们将与NRG肿瘤学统计中心合作
制定分析策略来研究评估治疗耐受性的新方法,并建模
使用随机NSABP试验的数据,用于数据显示的新方法,这些方法包含两个常见
不良事件的术语标准(CTCAE)数据和高质量的患者报告的结果(PRO)数据。
随后,我们将将这些新的分析方法和其他方法应用于NRG肿瘤学阶段
临床试验,包括促进症的项目,以评估与免疫疗法相关的治疗毒性。
在这一最新一代的免疫疗法试验中纳入亲CTCAE项目尤为重要,因为
来自早期免疫疗法研究的PRO数据有限,耐受性可能是一个关键问题
辅助治疗或早期转移性疾病环境中的患者是患者的患者
试验。我们以前制定了一项摘要措施,即毒性指数(TI),以根据基于患者进行区分
他们的整体毒性经历。根据根据AE分级AE的每个受试者总结毒性数据
ctcae。 TI占所有观察到的毒性等级,而不是最严重的毒性等级
完毕。由于其对整体毒性差异的敏感性,TI可能也对识别也很有用
预测与治疗相关的毒性的指标。除了本文所述的其他新方法外,我们还将采用
IT的TI和扩展或改进,以支持Pro和相关不利的新方法和改进的方法
事件数据。通过TI方法,此RFA中解决的问题非常适合部分解决方案。我们
还建议与肿瘤学家,专家专家和患者倡导者合作修改它,以解决
AES的持续时间和频率以及Pro-CTCAE数据的其他特殊需求。虽然我们将集中精力
在开发新的技术统计方法时,我们将成为专家,肿瘤学家,数据的团队
科学家和临床试验专家,以保持发展中以患者为中心和临床试验的发展相关
观点。此应用程序的具体目的是:目标1:应用和扩展TI和其他方法
描述毒性并开发模型以确定AE的危险因素。 (a)开发新的图形方法
描述毒性; (b)开发新的纵向模型,以确定缺少数据以确定的风险因素
aes; (c)将我们的新方法与现有方法进行比较,例如最高级/最大时间,TAME和TOXT;
(d)改进,扩展并将Ti应用于Pro-CTCAE,以建模CTCAE数据。目标2:开发预测模型
限制剂量毒性,治疗完成和基于个体患者特征的功效
Ti和Pro-Ti定义的毒性曲线。 (a)为完成和效力作为时间的预测模型
事件成果; (b)使用基于耐受性的各种定义开发最佳剂量的预测模型
ctcae和pro-ctcae; (c)开发和传播Web应用程序以实施开发的方法;
(d)使用多学科专家和患者倡导者审查和指导开发的方法。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
PATRICIA A. GANZ其他文献
PATRICIA A. GANZ的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('PATRICIA A. GANZ', 18)}}的其他基金
Cognitive Training for Cancer-related Cognitive Impairment: A Multi-Center Randomized Controlled Trial
癌症相关认知障碍的认知训练:多中心随机对照试验
- 批准号:
10562299 - 财政年份:2023
- 资助金额:
$ 65.03万 - 项目类别:
Advancing Analysis and Interpretation of Adverse Events and PROs in Cancer Clinical Trials
推进癌症临床试验中不良事件和 PRO 的分析和解释
- 批准号:
10884827 - 财政年份:2023
- 资助金额:
$ 65.03万 - 项目类别:
Advancing Analysis and Interpretation ofAdverse Events and PROs in Cancer Clinical Trials
推进癌症临床试验中不良事件和 PRO 的分析和解释
- 批准号:
10241463 - 财政年份:2018
- 资助金额:
$ 65.03万 - 项目类别:
Advancing Analysis and Interpretation ofAdverse Events and PROs in Cancer Clinical Trials
推进癌症临床试验中不良事件和 PRO 的分析和解释
- 批准号:
9788322 - 财政年份:2018
- 资助金额:
$ 65.03万 - 项目类别:
ENHANCING OUTCOMES IN YOUNG BREAST CANCER SURVIVORS: A PROGRAM OF THE UCLA-LIVEST
提高年轻乳腺癌幸存者的治疗效果:UCLA-LIVEST 项目
- 批准号:
8332706 - 财政年份:2011
- 资助金额:
$ 65.03万 - 项目类别:
ENHANCING OUTCOMES IN YOUNG BREAST CANCER SURVIVORS: A PROGRAM OF THE UCLA-LIVEST
提高年轻乳腺癌幸存者的治疗效果:UCLA-LIVEST 项目
- 批准号:
8294044 - 财政年份:2011
- 资助金额:
$ 65.03万 - 项目类别:
ENHANCING OUTCOMES IN YOUNG BREAST CANCER SURVIVORS: A PROGRAM OF THE UCLA-LIVEST
提高年轻乳腺癌幸存者的治疗效果:UCLA-LIVEST 项目
- 批准号:
8497454 - 财政年份:2011
- 资助金额:
$ 65.03万 - 项目类别:
VITAMIN D IN BREAST CANCER: A CROSS-SECTIONAL OBSERVATIONAL STUDY IN RECENTLY DI
维生素 D 在乳腺癌中的作用:近期 DI 的一项横断面观察研究
- 批准号:
8167136 - 财政年份:2009
- 资助金额:
$ 65.03万 - 项目类别:
THE UCLA FAMILIAL CANCER REGISTRY AND GENETIC EVALUATION PROGRAM
加州大学洛杉矶分校家族癌症登记和基因评估计划
- 批准号:
8167123 - 财政年份:2009
- 资助金额:
$ 65.03万 - 项目类别:
相似国自然基金
时空序列驱动的神经形态视觉目标识别算法研究
- 批准号:61906126
- 批准年份:2019
- 资助金额:24.0 万元
- 项目类别:青年科学基金项目
本体驱动的地址数据空间语义建模与地址匹配方法
- 批准号:41901325
- 批准年份:2019
- 资助金额:22.0 万元
- 项目类别:青年科学基金项目
大容量固态硬盘地址映射表优化设计与访存优化研究
- 批准号:61802133
- 批准年份:2018
- 资助金额:23.0 万元
- 项目类别:青年科学基金项目
IP地址驱动的多径路由及流量传输控制研究
- 批准号:61872252
- 批准年份:2018
- 资助金额:64.0 万元
- 项目类别:面上项目
针对内存攻击对象的内存安全防御技术研究
- 批准号:61802432
- 批准年份:2018
- 资助金额:25.0 万元
- 项目类别:青年科学基金项目
相似海外基金
Prostate Specific Anti-androgen Therapy for Localized Prostate Cancer
前列腺特异性抗雄激素疗法治疗局限性前列腺癌
- 批准号:
10760194 - 财政年份:2023
- 资助金额:
$ 65.03万 - 项目类别:
Regulatory Mechanisms Addressing Diabetic Vasculopathy
解决糖尿病血管病变的调节机制
- 批准号:
10718850 - 财政年份:2023
- 资助金额:
$ 65.03万 - 项目类别:
Brain Networks of Turning Performance with Aging and Stroke
衰老和中风影响转向性能的大脑网络
- 批准号:
10536898 - 财政年份:2022
- 资助金额:
$ 65.03万 - 项目类别:
Subclonal heterogeneity and outcome disparities in Triple-Negative Breast Cancer among African Americans
非裔美国人三阴性乳腺癌的亚克隆异质性和结果差异
- 批准号:
10596525 - 财政年份:2022
- 资助金额:
$ 65.03万 - 项目类别:
Neonatal Opioid Withdrawal Syndrome (NOWS) in Kentucky: Improving Outcomes for Infants
肯塔基州新生儿阿片类药物戒断综合症 (NOWS):改善婴儿的预后
- 批准号:
10380355 - 财政年份:2021
- 资助金额:
$ 65.03万 - 项目类别: