Existing data sources for clinical epidemiology: Aarhus University Clinical Trial Candidate Database, Denmark
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.
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Book•
14 Jan 2002
TL;DR: This work focuses on Ethical, Regulatory and Legal Issues, Ethical Principles in Clinical Research, and Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine.
Abstract: Preface. Acknowledgements. Historical Perspective and Introduction. Part I: Ethical, Regulatory and Legal Issues Ethical Principles in Clinical Research. Researching a Bioethical Question. Integrity in Research: Individual and Institutional Responsibility. Institutional Review Boards. Data and Safety Monitoring Boards. Data and Data Management in Clinical Trials. Unanticipated Risk in Clinical Research. The Regulation of Drugs and Biological Products by the Food and Drug Administration. Legal Issues. NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research. Part II: Biostatistics and Epidemiology An Introduction to Biostatistics: Randomization, Hypothesis Testing and Sample Size. Design and Conduct of Observational Studies and Clinical Trials. Small Clinical Trials. Large Clinical Trials Clinical Research Institutes. Using Secondary Data in Statistical Analysis. An Introduction to Survival Analysis. Measures of Function and Health Related to Quality of Life. Economic Analysis and Clinical Research. Part III: Technology Transfer, Protocol Development and Funding Overview of Technology Development. Technology Transfer. Telemedicine Systems. Animal Models of Human Disease. Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine. Preparing Scientific Images for Publication and Display. Writing a Clinical Protocol The Mechanics. Navigating the Peer Review Process for Grants.
102 citations
TL;DR: The hospital discharge registry showed relatively few misclassifications and the Danish National Registry of Patients (NRP), which is based on the regional registries, may provide a unique study base for future research.
Abstract: We estimated the validity, i.e., whether the diagnostic criteria were fulfilled for the patients registered with the diagnosis of liver cirrhosis in a Danish hospital discharge registry, and the completeness, i.e., whether all patients with liver cirrhosis were included in the registry. Information in the regional hospital discharge registry in the Country of Aarhus, Denmark was compared with hospital records and information in a pathology registry. 85.4% of the patients registered with a diagnosis of liver cirrhosis fulfilled the diagnostic criteria for the diagnosis (validity). 93.2% of the patients registered with biopsy proven liver cirrhosis in the pathology registry were found in the discharge registry (completeness) with a diagnosis of liver cirrhosis. The hospital discharge registry showed relatively few misclassifications and the Danish National Registry of Patients (NRP), which is based on the regional registries, may provide a unique study base for future research.
93 citations
TL;DR: The conclusion is that with careful attention to the limitations in the data, discharge diagnoses for patients with records of RA in the Danish NPR can be used for epidemiological research purposes; however, general carefulness is prompt when using non-audited registries for research in RA.
Abstract: Discharge diagnoses following hospital admissions in Denmark are recorded in the Danish National Patient Registry (NPR). Such routine hospitalization records may serve as useful research tools in epidemiological studies. The aim of the study was to provide measures of the validity and completeness of rheumatoid arthritis (RA) diagnoses recorded in the NPR. We identified medical records for 217 patients recorded as having RA in the NPR between 1977 and 2001. Using two definitions of RA (clinically confirmed RA and fulfilment of the American College of Rheumatology (ACR) 1987 diagnostic criteria for RA), a rheumatologist assessed the proportion of RA diagnoses recorded in the NPR that could be confirmed by scrutiny of the original medical records. The completeness of RA diagnoses in the NPR was estimated by a two-sample capture-recapture method. Overall, 59% of the 217 RA diagnoses in the NPR were confirmed by information in the medical records. However, major differences were seen according to characteristics of the underlying hospital registrations. Generally, RA diagnoses were most often confirmed for patients registered as inpatients and for patients with more than one hospital registration with RA. Specifically, only 42% of patients with one RA registration from a rheumatology department were confirmed as having RA. In contrast, 91% of patients treated at a rheumatology department and having three or more hospital registrations with RA were confirmed as having RA. The completeness of the NPR with respect to RA satisfying the ACR 1987 classification criteria was estimated to 26%. Our conclusion is that with careful attention to the limitations in the data, discharge diagnoses for patients with records of RA in the Danish NPR can be used for epidemiological research purposes; however, our findings prompt general carefulness when using non-audited registries for research in RA.
83 citations
01 Jan 2009
61 citations
Journal Article•
TL;DR: The Danish Cerebral Palsy Registry is a research registry that contains cases of CP from birth year 1925 and has estimated the birth prevalence since 1950, and changes over time are analysed and correlated with pre- and perinatal conditions.
Abstract: Cerebral palsy (CP) is the commonest disabling impairment in childhood, with a prevalence of 2-3 per 1000 live births. The Danish Cerebral Palsy Registry is a research registry that contains cases of CP from birth year 1925 and has estimated the birth prevalence since 1950. Data on children with CP are collected from paediatric departments and one special institution for disabled children. The children are included by a child neurologist and an obstetrician, and information on pregnancy, birth, neonatal period, impairments and demographic data on the child and mother are registered in a standard form. The uptake area is eastern Denmark, covering about 50% of the population, but the rest of Denmark is planned to be included from 2001. The Registry is large, well established and validated, and the definitions and collection procedures have not changed through several decades. It therefore has great research potential. Birth prevalence is estimated continuously, and changes over time are analysed and correlated with pre- and perinatal conditions. A correlation between increased survival of preterm babies and an increased prevalence was found previously, and a decreased prevalence in very preterm infants was later associated with less use of mechanical ventilation. A study correlating CP and maternal infection is ongoing. Collaboration between 14 European CP registries allows the true differences in prevalence between different countries to be studied. Linkage to other individually based registries in Denmark will allow the social consequences of CP to be described.
61 citations