OpenClinica: Open Source Platform for Clinical Research

OpenClinica：临床研究开源平台

• 批准号: 8005812
• 负责人: CAL T COLLINS
• 金额: $ 28.98万
• 依托单位: AKAZA RESEARCH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-10 至 2011-06-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8005812
• 关键词: Address; Biological Products; Businesses; Case Report Form; Clinical; Clinical Research; Code; Communities; Computer Systems; Computer software; Connecticut; Data; Data Sources; Defect; Development; Documentation; Electronics; Environment; Good Clinical Practice; Government Agencies; Growth; Head; Health; Healthcare; Incentives; Industry; Institute of Medicine (U.S.); International; Licensing; Maintenance; Metadata; Modeling; Monitor; Paper; Patient Outcomes Assessments; Patients; Peer Review; Phase; Process; Published Comment; Research; Research Contracts; Research Infrastructure; Rewards; Science; Semantics; Services; Small Business Innovation Research Grant; Solutions; Source; System; Technology; Testing; Translational Research; United States National Institutes of Health; Universities; Validation; Vendor; Work; base; cluster computing; cohesion; data exchange; design; diaries; electronic data; empowered; federated computing; flexibility; improved; innovation; interoperability; meetings; model development; open source; public health research; research and development; research study; software development; software systems; syntax; theories; tool

DESCRIPTION (provided by applicant): We believe a key barrier to transforming clinical research is the lack of open, integrated, transparent technology solutions that address bottlenecks in information integration and business process management. Our viewpoint is supported by a recent Forrester Research study that identifies proprietary software as "one of the biggest barriers" to interoperability in the health IT environment, and suggests wider use of open source software to address integration challenges. I This project will build on Akaka's OpenClinica platform, the leading open source clinical research solution, to develop a broad-based open source software infrastructure that enables interoperability in heterogeneous clinical and translational research, and to develop targeted commercially-supported open source solutions from this infrastructure. It will: Integrate research data across distributed heterogeneous data sources, even data from legacy sources with poor interfaces and data documentation. Automate exchange of information with other systems in the healthcare and clinical research enterprises via semantically harmonized domain models and standardized messaging interfaces. Facilitate transition of paper-based processes to electronic systems for electronic data capture of case report forms (CRFs) and patient diaries (ePRO, or electronic Patient Reported Outcomes). Improve research management and monitoring in a Good Clinical Practice-compliant environment. The resulting solution will advance the capabilities of the clinical and translational research enterprise and empower collaborative research at Academic Health Centers (AHCs), government agencies, Contract Research Organizations (CROs), and the biopharmaceutical industry. It will increase the throughput and efficiency of clinical research, operate reliably in heterogeneous environments, and enable new types of research by bringing together disparate research tools and data.

描述（由申请人提供）：我们认为，转变临床研究的一个关键障碍是缺乏开放、集成、透明的技术解决方案，以解决信息集成和业务流程管理方面的瓶颈。Forrester Research最近的一项研究支持了我们的观点，该研究将专有软件确定为医疗IT环境中互操作性的“最大障碍之一”，并建议更广泛地使用开源软件来解决集成挑战。该项目将建立在Akaka的OpenClinica平台（领先的开源临床研究解决方案）上，开发一个广泛的开源软件基础设施，使异构临床和转化研究能够互操作性，并从该基础设施开发有针对性的商业支持的开源解决方案。它将：集成跨分布式异构数据源的研究数据，甚至是来自接口和数据文档较差的遗留数据源的数据。通过语义协调的领域模型和标准化消息传递接口，自动与医疗保健和临床研究企业中的其他系统交换信息。促进纸质流程向电子系统过渡，以获取病例报告表格（CRFs）和患者日记（ePRO或电子患者报告结果）的电子数据。在符合良好临床规范的环境中改进研究管理和监测。由此产生的解决方案将提高临床和转化研究企业的能力，并增强学术健康中心（AHCs）、政府机构、合同研究组织（cro）和生物制药行业的合作研究能力。它将提高临床研究的吞吐量和效率，在异构环境中可靠地运行，并通过汇集不同的研究工具和数据来实现新型研究。