Toxicity Monitoring on Phase III Trials with Administrative Data

使用管理数据进行 III 期试验的毒性监测

基本信息

批准号：
8519978
负责人：
Richard Aplenc
金额：
$ 46.16万
依托单位：
CHILDREN'S HOSP OF PHILADELPHIA
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-03 至 2016-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8519978
关键词：
Accounting Acute Myelocytic Leukemia Administrator Adult Adverse event Caring Cessation of life Charge Child Childhood Childhood Acute Myeloid Leukemia Children&apos s Oncology Group Clinical Data Clinical Trials Clinical Trials Cooperative Group Code Cost Analysis Data Data Set Data Sources Databases Development Diagnosis Effectiveness Enrollment Face Funding Health Information System Institute of Medicine (U.S.)International Lead Malignant Childhood Neoplasm Malignant Neoplasms Methodology Methods Molecular Cytogenetics Monitor National Cancer Institute Oncology Group Outcome Patients Pediatric Hospitals Pharmaceutical Preparations Phase Phase III Clinical Trials Policy Maker Predictive Value Procedures Process Public Health Recommendation Relapse Reporting Research Personnel Residual Neoplasm Resources Sensitivity and Specificity Site System Therapy Clinical Trials Toxic effect Toxicity Tests Treatment Cost Treatment Protocols Variant Work administrative database arm cancer therapy clinical epidemiology cost effectiveness trial improved innovation molecular phenotype novel success

项目摘要

DESCRIPTION (provided by applicant): National Cancer Institute (NCI) funded cooperative oncology group trials have improved overall survival for children with cancer from 10% to 85% over the past five decades, and have set standards of care for adults with malignancies. However, according to the Institute of Medicine: "the clinical trial system is approaching a state of crisis". If [it] does not improve its efficiency and effectiveness, the introduction of new treatments for cancer will be delayed and patient lives will be lost unnecessarily. This application proposes to improve toxicity monitoring, estimate treatment associated resource utilization and costs, and serve as a platform for answering important clinical epidemiology questions by merging data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) administrative data base for patients treated for de novo acute myeloid leukemia (AML) on recent Phase III clinical trials. Four hypotheses underpin this application: (1) We hypothesize that greater than 95% of patients enrolled on recent and current COG AML trials can be identified in PHIS; (2) COG-PHIS merged data will more accurately report adverse events than unmerged data; (3) COG-PHIS merged data can prospectively monitor a Phase III trial for adverse events; (4) COG-PHIS merged data will describe standardized costs of treatment by regimen arm and enable analyses of cost variation. This application has significance both as a methodological advancement and in the use of this methodology to improve toxicity monitoring and outcome analysis in cooperative group oncology trials. Furthermore, this application is highly innovative as the first merging of cooperative grou clinical trial data with administrative data. Finally, the approach taken in this application shoul be applicable not only to other pediatric malignancies, but also to adult cancers generally. Thus, the application is likely to have a high impact on the care of both children and adults with cancer.

描述（由申请人提供）：美国国家癌症研究所 (NCI) 资助的合作肿瘤学小组试验在过去 50 年中将癌症儿童的总生存率从 10% 提高到 85%，并为患有恶性肿瘤的成人制定了护理标准。然而，医学研究所表示：“临床试验系统正接近危机状态”。如果不提高其效率和有效性，癌症新疗法的推出将被推迟，患者的生命将不必要地丧失。该应用程序旨在通过合并儿童肿瘤学组 (COG) 和儿科健康信息系统 (PHIS) 管理数据库的数据来改进毒性监测、估计治疗相关的资源利用率和成本，并作为回答重要临床流行病学问题的平台适用于最近 III 期临床试验中接受新发急性髓系白血病 (AML) 治疗的患者。该应用有四个假设：(1) 我们假设参加最近和当前 COG AML 试验的超过 95% 的患者可以在 PHIS 中识别； (2) COG-PHIS 合并数据将比未合并数据更准确地报告不良事件； (3) COG-PHIS 合并数据可以前瞻性地监测 III 期试验的不良事件； (4) COG-PHIS 合并数据将描述治疗组的标准化治疗成本，并能够分析成本变化。该应用作为方法学的进步以及使用该方法来改进合作团体肿瘤学试验中的毒性监测和结果分析都具有重要意义。此外，作为首次将合作团体临床试验数据与管理数据合并，该应用程序具有高度创新性。最后，本申请中采用的方法不仅应适用于其他儿科恶性肿瘤，而且还应适用于一般成人癌症。因此，该应用程序可能会对患有癌症的儿童和成人的护理产生重大影响。