OpenClinica: Open Source Platform for Clinical Research

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中的瓶颈。我们的观点得到了Forrester Research最近的一项研究的支持，该研究确定专有软件是医疗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放源码软件来解决集成挑战。I这个项目将建立在Akaka的OpenClinica平台上，这是领先的开源临床研究解决方案，以开发一个基础广泛的开源软件基础设施，使不同的临床和翻译研究能够互操作，并从这个基础设施开发有针对性的商业支持的开源解决方案。它将：跨分布的异类数据源集成研究数据，甚至是来自界面和数据文档较差的遗留源的数据。通过语义协调的域模型和标准化的消息传递接口，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，以便以电子方式获取病例报告表(CRF)和患者日记(ePRO，或电子患者报告结果)的数据。在符合临床实践的良好环境中改进研究管理和监测。由此产生的解决方案将提升临床和转化性研究企业的能力，并支持学术卫生中心(AHCs)、政府机构、合同研究组织(CRO)和生物制药行业的协作研究。它将提高临床研究的吞吐量和效率，在不同的环境中可靠地运行，并通过将不同的研究工具和数据整合在一起来支持新型研究。

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.