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Existing data sources for clinical epidemiology: Aarhus University Clinical Trial Candidate Database Denmark

机译:现有的临床流行病学数据来源:丹麦奥尔胡斯大学临床试验候选数据库

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摘要

Denmark is facing a reduction in clinical trial activity as the pharmaceutical industry has moved trials to low-cost emerging economies. Competitiveness in industry-sponsored clinical research depends on speed, quality, and cost. Because Denmark is widely recognized as a region that generates high quality data, an enhanced ability to attract future trials could be achieved if speed can be improved by taking advantage of the comprehensive national and regional registries. A “single point-of-entry” system has been established to support collaboration between hospitals and industry. When assisting industry in early-stage feasibility assessments, potential trial participants are identified by use of registries to shorten the clinical trial startup times. The Aarhus University Clinical Trial Candidate Database consists of encrypted data from the Danish National Registry of Patients allowing an immediate estimation of the number of patients with a specific discharge diagnosis in each hospital department or outpatient specialist clinic in the Central Denmark Region. The free access to health care, thorough monitoring of patients who are in contact with the health service, completeness of registration at the hospital level, and ability to link all databases are competitive advantages in an increasingly complex clinical trial environment.
机译:随着制药行业将试验转移到低成本的新兴经济体,丹麦面临的临床试验活动减少。行业赞助的临床研究的竞争力取决于速度,质量和成本。由于丹麦被公认为生成高质量数据的地区,因此,如果可以利用综合的国家和地区注册机构来提高速度,则可以增强吸引未来试验的能力。已经建立了“单入口点”系统来支持医院与行业之间的协作。在协助行业进行早期可行性评估时,通过使用注册表来识别潜在的试验参与者,以缩短临床试验启动时间。奥尔胡斯大学临床试验候选数据库包含来自丹麦国家患者注册中心的加密数据,可以立即估计丹麦中部地区每个医院部门或门诊专科诊所有特定出院诊断的患者数量。在日益复杂的临床试验环境中,免费获得医疗保健,对与医疗服务机构联系的患者进行全面监控,在医院一级完成注册的完整性以及链接所有数据库的能力是竞争优势。

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