Creating An Efficient Clinical Trial Build System via The Clinical Trials Rapid Activation Consortium (CTRAC)

通过临床试验快速激活联盟 (CTRAC) 创建高效的临床试验构建系统

• 批准号: 10227524
• 负责人: HOWARD H. BAILEY
• 金额: $ 30.02万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10227524
• 关键词: Address; Adverse event; Area; Automation; Cancer Burden; Cancer Center; Catchment Area; Clinical; Clinical Trials; Clinical Trials Network; Clinical trial protocol document; Communities; Complex; Custom; Development; Disease; Education; Electronic Health Record; Expenditure; Formularies; Future; Goals; Individual; Infrastructure; Institution; Intervention Studies; Investigational Therapies; Laboratories; Leadership; Malignant Neoplasms; Manuals; Medication Errors; Mentorship; Methods; Mission; Modification; Patient Care; Patients; Pharmaceutical Preparations; Policies; Population Research; Procedures; Process; Protocols documentation; Provider; Research; Research Personnel; Resources; Site; Specific qualifier value; Standardization; Structure; System; Testing; Time; Universities; Vendor; Wisconsin; Work; anticancer research; arm; base; cancer care; care providers; cost; imaging biomarker; improved; innovation; member; neoplasm resource; next generation; novel; population based; standard of care; support network; treatment planning

PROJECT SUMMARY Standard-of-care electronic health records (EHR)-based treatment plans support efficiency and quality through standardization. However, treatment-plan builds for clinical trials, irrespective of the number of patients, must be built from the ground up for each new trial and at each added site. Additionally, investigational treatment plans often require configurations for novel medications, numerous ancillary procedures, and research finance requirements. The current paradigm is costly, complex, and inefficient. Representatives of five cancer centers agreed to be part of the project’s Clinical Trials Rapid Activation Consortium (CTRAC). The project’s goal is to develop processes across multiple NCI-supported cancer centers that will facilitate the development of single builds of EHR clinical-trial treatment plans that can be deployed at multiple institutions in support of NCI- sponsored network studies. Members will investigate the question: can a small consortium of clinical trials sites develop methods to standardize workflows, drug formularies, drug administration procedures, and laboratory requirements leading to the creation of the components for a standardized, electronic, clinical trials build system? Specific aims are as follows: 1) To identify the tasks currently performed by EHR investigational treatment plans (SOPs, policies, and workflows) and to define differences among these SOPs at the individual member sites of the consortium; 2) To standardize the processes within each task where possible and document differences that would require modifications across sites; 3) To develop a master assessment of EHR treatment-plan modules that could be reused to perform components of the same research protocol tasks at multiple sites while maintaining compliance with the requirements of member organizations of the consortium; 4) To organize a leadership structure for the consortium that will work with the NCI and an EHR provider to oversee this initiative to assure that adequate progress is made toward the ultimate goal of creating a more automated electronic clinical-trial build system that will facilitate the activation of clinical trials across all NCI- supported networks; 5) To build standardized electronic clinical-trial build modules that could undergo future pilot testing at each institution for a specified group of NCI-sponsored clinical trials; and 6) To facilitate development of metrics for the new EHR processes that can demonstrate whether more consistent patient care, reduced medication errors, and fewer adverse events result from a standardized approach to clinical- trial build modules.

项目总结 基于医疗标准电子健康记录(EHR)的治疗计划支持效率和质量 通过标准化。然而，临床试验的治疗计划建立，无论有多少 对于每个新的试验和每个增加的地点，必须从头开始建立患者。另外， 研究治疗计划通常需要配置新的药物、许多辅助药物 程序和研究经费要求。当前的模式成本高昂、复杂，而且 效率低下。五个癌症中心的代表同意参加该项目的快速临床试验 激活联盟(CTRAC)。该项目的目标是开发跨多个NCI支持的流程 癌症中心将促进开发单一版本的EHR临床试验治疗计划， 可以部署在多个机构，以支持NCI赞助的网络研究。成员将 调查这个问题：一个临床试验站点的小联盟能否开发出标准化的方法 工作流程、药物处方、给药程序和实验室要求 创建标准化、电子化、临床试验构建系统的组件？具体目标是 1)确定目前由EHR研究治疗计划(SOP、政策、 和工作流程)，并定义这些SOP之间在各个成员站点的差异 联盟；2)在可能的情况下标准化每项任务中的流程，并记录差异 将需要跨站点进行修改；3)制定EHR治疗计划的总体评估 可重复使用的模块，用于在多个站点执行相同研究协议任务的组件 同时保持遵守联合体成员组织的要求；4) 组织财团的领导结构，该财团将与NCI和EHR提供商合作，以 监督这一计划，以确保朝着创造更多 自动化电子临床试验构建系统，将促进激活所有NCI- 支持的网络；5)建立标准化的电子临床试验构建模块，可以在未来 在每个机构为NCI赞助的一组指定的临床试验进行试点测试；以及6)促进 为新的电子病历流程制定衡量标准，以证明更一致的患者 医疗护理、减少用药差错和不良事件的减少源于标准化的临床方法- 试用构建模块。