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: 10227589
• 负责人: STEVEN Terry ROSEN
• 金额: $ 30万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 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 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10227589
• 关键词: Adverse event; Cancer Center; Clinical Trials; Complex; Custom; Development; Electronic Health Record; Expenditure; Formularies; Future; Goals; Individual; Institution; Investigational Therapies; Laboratories; Leadership; Manuals; Medication Errors; Methods; Modification; Participant; Patient Care; Pharmaceutical Preparations; Policies; Procedures; Process; Protocols documentation; Provider; Research; Site; Specific qualifier value; Standardization; Structure; System; Testing; Time; Work; arm; cost; member; novel; standard of care; support network; treatment planning

PROJECT SUMMARY/ABSTRACT Standard-of-care electronic health records (EHR) treatment plans are constructed once prior to implementation and support quality through standardization. By comparison, treatment-plan builds for clinical trials may support as few as zero trial participants, must be built from the ground up for each new trial and at each added site, and have treatment plans that 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? The 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 fully 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.

项目摘要/摘要 医疗标准电子健康记录(EHR)治疗计划在实施之前构建一次 并通过标准化来支持质量。相比之下，临床试验的治疗计划构建可能会支持 对于每个新的试验和每个增加的地点，必须从头开始建立少到零个试验参与者， 并有治疗计划，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。目前的模式成本高昂、复杂且效率低下。 五个癌症中心的代表同意成为该项目临床试验快速激活的一部分 财团(CTRAC)。该项目的目标是开发跨越多种NCI支持的癌症的过程 中心将促进开发单一版本的EHR临床试验治疗计划，这些计划可以 部署在多个机构，以支持NCI赞助的网络研究。委员将会调查 问：一个临床试验站点的小联盟能否开发出标准化工作流程、药物 处方、给药程序和实验室要求导致建立 标准化、电子化、临床试验构建系统的组件？具体目标如下：1) 确定目前由EHR研究治疗计划(SOP、政策和工作流程)执行的任务 并在联合体的各个成员站点确定这些SOP之间的差异；2) 尽可能标准化每项任务中的流程，并记录需要 跨站点修改；3)开发EHR治疗计划模块的总体评估，该模块可以 重复使用以在多个站点执行相同研究协议任务的组件，同时维护 遵守联合体成员组织的要求；4)组织领导 将与NCI和EHR提供商合作的财团的结构，以监督这一倡议，以确保 朝着创建完全自动化的电子临床试验的最终目标取得了足够的进展 建立系统，促进在NCI支持的所有网络中激活临床试验；5)建立 标准化的电子临床试验构建模块，可以在每个机构进行未来的试点测试 指定的一组由NCI赞助的临床试验；以及6)促进新的EHR指标的开发 能够证明更一致的患者护理、更少的用药错误和更少的 不良事件源于临床试验构建模块的标准化方法。