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An Automatized Model for Sequential Monitoring of Effectiveness of New Drugs using Dronedarone as Example
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. (Kardiologi)ORCID iD: 0000-0001-7998-6017
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. (Kardiologi)
(English)Manuscript (preprint) (Other academic)
Keyword [en]
comparative effectiveness research, comparative safety research, propensity score, dronedarone, flecainide, sequential monitoring
National Category
Cardiac and Cardiovascular Systems
Research subject
Pharmacoepidemiology
Identifiers
URN: urn:nbn:se:uu:diva-304322OAI: oai:DiVA.org:uu-304322DiVA: diva2:1015113
Available from: 2016-10-04 Created: 2016-10-04 Last updated: 2016-10-10
In thesis
1. Real-Time Monitoring of Healthcare Interventions in Routine Care: Effectiveness and Safety of Newly Introduced Medicines
Open this publication in new window or tab >>Real-Time Monitoring of Healthcare Interventions in Routine Care: Effectiveness and Safety of Newly Introduced Medicines
2016 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Before market authorization of new medicines, their efficacy and safety are evaluated using randomized controlled trials. While there is no doubt about the scientific value of randomized trials, they are usually conducted in selected populations with questionable generalizability to routine care. 

In the digital data revolution era, with healthcare data growing at an unprecedented rate, drug monitoring in routine care is still highly under-utilized. Although many countries have access to data on prescription drugs at the individual level in ambulatory care, such data are often missing for hospitals. This is a growing problem considering the clear trend towards more new and expensive drugs administered in the hospital setting. The aim of this thesis was therefore to develop methods for extracting data on drug use from a hospital-based electronic health record system and further to build and evaluate models for real-time monitoring of effectiveness and safety of new drugs in routine care using data from electronic health records and regional and national health care registers.

Using the developed techniques, we were able to demonstrate drug use and health service utilization for inflammatory bowel disease and to evaluate the comparative effectiveness and safety of antiarrhythmic drugs.

With a rapidly evolving drug development, it is important to optimize the evaluation of effectiveness, safety and health economic value of new medicines in routine care. We believe that the models described in this thesis could contribute to fulfil this need.

Place, publisher, year, edition, pages
Uppsala: Uppsala University, 2016. 76 p.
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1260
Keyword
Electronic Health Records, Comparative Effectiveness Research, Comparative Safety Research, Sequential drug monitoring, propensity score, real-world data, infliximab, TNF-inhibitors, dronedarone, amiodarone, flecainide
National Category
Public Health, Global Health, Social Medicine and Epidemiology Public Health, Global Health, Social Medicine and Epidemiology
Research subject
Pharmacoepidemiology
Identifiers
urn:nbn:se:uu:diva-304324 (URN)978-91-554-9707-1 (ISBN)
Public defence
2016-11-19, Rudbeckssalen, Dag Hammarskjölds väg 20, Uppsala, 09:15 (English)
Opponent
Supervisors
Available from: 2016-10-26 Created: 2016-10-04 Last updated: 2016-11-02

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