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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.

AbstractDenmark 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.

Topics: Clinical trial (55%), Health care (51%)

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Journal ArticleDOI
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.

5 citations


References
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Journal ArticleDOI
TL;DR: The Danish Civil Registration System (CRS) in connection with other registers and biobanks will continue to provide the basis for significant knowledge relevant to the aetiological understanding and possible prevention of human diseases.
Abstract: Introduction: The Danish Civil Registration System (CRS) was established in 1968, and all persons alive and living in Denmark were registered for administrative use. Content: CRS includes individual information on the unique personal identification number, name, gender, date of birth, place of birth, citizenship, identity of parents and continuously updated information on vital status, place of residence and spouses. Validity and coverage: Since 1968, CRS has recorded current and historical information on all persons living in Denmark. Among persons born in Denmark in 1960 or later it contains complete information on maternal identity. For women born in Denmark in April 1935 or later it contains complete information on all their children. CRS contains complete information on immigrations and emigrations from 1969 onwards, permanent residence in a Danish municipality from 1971 onwards, and full address in Denmark from 1977 onwards. Conclusion: CRS in connection with other registers and biobanks will continue to provide the basis for significant knowledge relevant to the aetiological understanding and possible prevention of human diseases.

3,078 citations


Journal ArticleDOI
TL;DR: Although the NPR is overall a sound data source, both the content and the definitions of single variables have changed over time and researchers using the data should carefully consider potential fallacies in the data before drawing conclusions.
Abstract: Introduction: The Danish National Patient Register (NPR) was established in 1977, and it is considered to be the finest of its kind internationally. Content: At the onset the register included information on inpatient in somatic wards. The content of the register has gradually been expanded, and since 2007 the register has included information on all patients in Danish hospitals. Validity and coverage: Although the NPR is overall a sound data source, both the content and the definitions of single variables have changed over time. Changes in the organisation and provision of health services may affect both the type and the completeness of registrations. Conclusion: The NPR is a unique data source. Researchers using the data should carefully consider potential fallacies in the data before drawing conclusions.

2,754 citations


Journal Article
TL;DR: The Danish National Hospital Register is well suited to contribute to international comparative studies with relevance for evidence-based medicine, and how researchers may get access to the Register is described.
Abstract: The Danish National Hospital Register (LPR) has collected nationwide data on all somatic hospital admissions since 1977, and since 1995 data on outpatients and emergency patients have been included as well. Numerous research projects have been undertaken in the national Danish context as well as in collaboration with international teams, and the LPR is truly a valuable source of data for health sciences, especially in epidemiology, health services research and clinical research. Nearly complete registration of somatic hospital events in Denmark is combined with ideal conditions for longterm follow-up due to the existence of a national system of unique person identification in a population of relative demographic stability. Examples of studies are provided for illustration within three main areas: I: Using LPR for surveillance of the occurrence of diseases and of surgical procedures, II: Using the Register as a sampling frame for longitudinal population based and clinical research, and III: Using the Register as a data source for monitoring outcomes. Data available from the Register as well as studies of the validity of the data are mentioned, and it is described how researchers may get access to the Register. The Danish National Hospital Register is well suited to contribute to international comparative studies with relevance for evidence-based medicine.

1,968 citations


Journal ArticleDOI
TL;DR: The possibility of linkage with many other nationwide individual-level data sources renders the DNPR a very powerful pharmacoepidemiological tool.
Abstract: Introduction: Individual-level data on all prescription drugs sold in Danish community pharmacies has since 1994 been recorded in the Register of Medicinal Products Statistics of the Danish Medicines Agency. Content: The register subset, termed the Danish National Prescription Registry (DNPR), contains information on dispensed prescriptions, including variables at the level of the drug user, the prescriber, and the pharmacy. Validity and coverage: Reimbursement-driven record keeping, with automated bar-code-based data entry provides data of high quality, including detailed information on the dispensed drug. Conclusion: The possibility of linkage with many other nationwide individual-level data sources renders the DNPR a very powerful pharmacoepidemiological tool.

1,440 citations


Journal ArticleDOI
TL;DR: Routine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI, and results were consistent across all major prespecified subgroups, including subgroups defined according toThrombus burden and coronary flow before PCI.
Abstract: BackgroundThe clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI ...

824 citations