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
基本信息
- 批准号:10227589
- 负责人:
- 金额:$ 30万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Adverse eventCancer CenterClinical TrialsComplexCustomDevelopmentElectronic Health RecordExpenditureFormulariesFutureGoalsIndividualInstitutionInvestigational TherapiesLaboratoriesLeadershipManualsMedication ErrorsMethodsModificationParticipantPatient CarePharmaceutical PreparationsPoliciesProceduresProcessProtocols documentationProviderResearchSiteSpecific qualifier valueStandardizationStructureSystemTestingTimeWorkarmcostmembernovelstandard of caresupport networktreatment planning
项目摘要
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.
项目总结/文摘
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)
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STEVEN Terry ROSEN其他文献
STEVEN Terry ROSEN的其他文献
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