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 实施之前构建了一次护理标准电子健康记录（EHR）治疗计划 并通过标准化支持质量。相比之下，用于临床试验的治疗计划可以支持 只需零试用参与者，就必须为每个新试验而从头开始建造，并且在每个附加的站点中， 并制定经常需要用于新型药物的配置的治疗计划，众多辅助药物 程序和研究财务要求。当前的范式是昂贵，复杂且效率低下的。 五个癌症中心的代表同意成为该项目临床试验的一部分快速激活 财团（CTRAC）。该项目的目标是开发多个NCI支持的癌症的过程 将有助于开发EHR临床治疗计划的单一建筑物的中心 部署在多个机构中，以支持NCI赞助的网络研究。成员将调查 问题：一个小的临床试验站点可以开发标准化工作流程的方法，药物 共同行为，药物管理程序和实验室要求，导致创建 标准化的，电子临床试验系统的组件？具体目的如下：1） 确定EHR研究治疗计划（SOP，政策和工作流程）当前执行的任务 并在财团的各个成员遗址中定义这些SOP之间的差异； 2）到 标准化每个任务中的过程，并记录需要的差异 跨站点的修改； 3）开发可能是EHR治疗计划模块的主评估 重新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 遵守财团的成员组织的要求； 4）组织领导 财团的结构将与NCI和EHR提供商合作，以监督该计划以确保 这一取得了足够的进步是为了创建全自动电子临床审判的最终目标 构建系统，将促进所有NCI支持网络的临床试验激活； 5）建造 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 一组指定的NCI赞助的临床试验； 6）促进新EHR的指标开发 可以证明更一致的患者护理，减少药物错误和更少的过程 不良事件是由标准化方法的临床试验构建模块产生的。