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Journal ArticleDOI

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

08 Apr 2014-Clinical Epidemiology (Dove Press)-Vol. 6, pp 129-135
TL;DR: Denmark is facing a reduction in clinical trial activity as the pharmaceutical industry has moved trials to low-cost emerging economies, but 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.
Abstract: 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.

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TL;DR: A substantial impact of the regulatory action to restrict use of SR in Europe is demonstrated: SR utilisation overall decreased strongly and the proportion of patients fulfilling the restricted indications, without contraindications, increased after the proposed RMMs.
Abstract: In May 2013 and March 2014, the European Medicines Agency (EMA) issued two decisions restricting the use of strontium ranelate (SR). These risk minimisation measures (RMM) introduced new contraindications and limited the indications of SR therapy. The EMA required an assessment of the impact of RMMs on the use of SR in Europe. Methods design: multi-national, multi-database cohort Setting: electronic medical record databases based on hospital (Denmark) and primary care provenance (Italy, Spain, the Netherlands, UK). Participants: the database source populations were included for population-based analyses, and SR users for patient-level analyses. Intervention: New RMMs included contraindications (ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, uncontrolled hypertension) and restricted SR indication to severe osteoporosis with initiation by experienced physician and not as first line anti-osteoporosis therapy. Prevalence and incidence rates of SR use in the population; prevalence of contraindications and restricted indications in SR users, plus 1-year therapy persistence. Drug use measures were calculated in three periods for comparison: reference (2004 to May 2013), transition (June 2013 to March 2014) and assessment (from April 2014 to end 2016). The study population included 143 million person-years(PY) of follow-up and 76,141 incident episodes of SR treatment. Average monthly prevalence rates of SR use dropped by 86.4% from 62.6/10,000 PY (95 CI 62.4–62.9) in the reference to 8.5 (8.5–8.6) in the assessment period. Similarly, the incidence rate of SR use fell by 97.3% from 7.4/10,000 PY (7.4–7.4) to 0.2 (0.2–0.2) between the reference and assessment period. The prevalence of any contraindication decreased, whilst the prevalence of restricted indications increased in these periods. One-year persistence decreased in the assessment compared with reference period. Our study demonstrates a substantial impact of the regulatory action to restrict use of SR in Europe: SR utilisation overall decreased strongly. The proportion of patients fulfilling the restricted indications, without contraindications, increased after the proposed RMMs.

9 citations

References
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Journal Article
TL;DR: The misclassification of hypertension may lead to an underestimation of risks of hypertension in various occupations in the Occupational Hospitalization Register or bias the occupational risk pattern of essential hypertension to become more alike that of arteriosclerotic diseases.
Abstract: This study validated hypertension (ICD-8: 401.99) in The National Inpatient Register with reference to the use of the diagnosis in the Occupational Hospitalization Register. A university hospital and a regional hospital were chosen for the evaluation. A sample of case records with the discharge diagnosis essential hypertension and additional case records with other diagnoses were re-coded blindly and independently by two doctors. Cause of admission or admission diagnosis was recorded for essential hypertension cases. The agreement with The National Inpatient Register ranged from 60 to 40%. About half of the cases with the discharge diagnosis "essential hypertension" were admitted to hospital due to hypertension, about a quarter due to diagnoses within "other arteriosclerotic diseases" (ICD-8: 400, 402-440). The misclassification may lead to an underestimation of risks of hypertension in various occupations in the Occupational Hospitalization Register or bias the occupational risk pattern of essential hypertension to become more alike that of arteriosclerotic diseases.

32 citations

Journal ArticleDOI
TL;DR: Event detection using population-based health care databases is a new research tool in interventional cardiology that may allow large, low-cost, randomized clinical trials to reflect daily clinical practice, covering a broad range of patients and end points with complete lifelong follow-up.
Abstract: AIM To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials. BACKGROUND Randomized clinical trials often focus on short-term efficacy and safety in a controlled environment. Trial follow-up may be linked with study-related investigations and differ from routine clinical practice. Because treatment and control in randomized trials differ from daily practice, trial results may have reduced general applicability and may be of limited value in clinical decision-making. Further, it is economically very costly to conduct randomized clinical trials. METHODS AND RESULTS Population-based health care databases collect data continuously and prospectively, and make it possible to monitor lifelong outcomes of cardiac interventions in large numbers of patients. This strengthens external validity by eliminating the effects of study-related monitoring or diagnostic tests. Further, follow-up data can be obtained at low expense. Importantly, data sources encompassing a complete population are likely to reflect clinical practice. Because population-based health care databases collect data for quality-control and administrative purposes unrelated to scientific investigations, certain biases, such as nonresponse bias, recall bias, and bias from losses to follow-up, can be avoided. CONCLUSION Event detection using population-based health care databases is a new research tool in interventional cardiology that may allow large, low-cost, randomized clinical trials to reflect daily clinical practice, covering a broad range of patients and end points with complete lifelong follow-up.

22 citations