Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
Clin Epidemiol. 2014 Apr 8;6:129-35. doi: 10.2147/CLEP.S60080. eCollection 2014.
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.
丹麦正面临临床试验活动减少的局面，因为制药行业已将试验转移到低成本的新兴经济体。行业赞助的临床研究的竞争力取决于速度、质量和成本。由于丹麦被广泛认为是一个能产生高质量数据的地区，如果能够通过利用全面的国家和地区登记系统来提高速度，那么提高吸引未来试验的能力是有可能实现的。建立了一个“单一入口点”系统，以支持医院和行业之间的合作。在协助行业进行早期可行性评估时，通过使用登记系统来确定潜在的试验参与者，从而缩短临床试验启动时间。奥胡斯大学临床试验候选者数据库包含来自丹麦全国患者登记处的加密数据，可立即估计丹麦中部地区每个医院科室或门诊专科诊所中具有特定出院诊断的患者数量。免费获得医疗保健、对与卫生服务接触的患者进行彻底监测、在医院层面进行完整的登记以及能够链接所有数据库，这些都是在日益复杂的临床试验环境中具有竞争力的优势。
