Status: Ongoing First registered on: 04/07/2023
Last updated on: 28/08/2023
1. Study identification
EU PAS Register NumberEUPAS105641
Official titleDARWIN EU® CC - Drug utilization study of prescription opioids
Study title acronym
Study typeObservational study
Brief description of the studyPrescription opioids, while effective for managing severe pain, have led to a public health crisis due to misuse, addiction, and overdose, particularly in the US. Recently, concerns have been growing in Europe due to increasing opioid use and related mortality. Factors such as chronic pain, mental health disorders, and advanced age can exacerbate misuse and the development of dependence. Given the potential for global spread of this issue, enhanced surveillance and in-depth research into opioid utilization patterns are imperative. A drug utilization study using a Common Data Model (CDM) is a promising approach to supplement European opioid monitoring systems, providing more granular data to inform evidence-based decisions on this complex topic. The European Medicines Agency commissioned this DARWIN EU© CC study to: (i) To investigate the annual incidence and annual period prevalence of use of opioids (overall, active drug substance, strength (weak/strong opioids) and route (oral, transdermal or parenteral)), stratified by calendar year, age, sex and country/database during the study period 2012-2022. (ii) To determine duration of prescription opioid use, as well as characteristics of new users and indication for opioid prescribing/dispensing, all stratified by calendar year and country/database.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDARWIN EU® CC
Centre locationRotterdam, the Netherlands
Details of (Primary) lead investigator
Title Dr
Last name Jodicke
First name Annika
Is this study being carried out with the collaboration of a research network?
Yes

DARWIN EU CC
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

IDIAPJGol
IQVIA
Health Data Science
Estonian Biobank, Estonia
Clinical Data Warehouse of Bordeaux University Hospital (CHUBX), France
Auria Clinical Informatics VARHA (ACI Varha), Finland
Countries in which this study is being conducted
International study

Belgium
Estonia
Finland
France
Germany
Netherlands
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/03/202330/03/2023
Start date of data collection01/01/201201/01/2012
Start date of data analysis
Date of interim report, if expected
Date of final study report01/11/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Jodicke
First name Annika
Address line 1University of Oxford
Address line 2Windmill Road 
Address line 3Headington 
CityOxford 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org
Public Enquiries
Title Mrs 
Last name Schuemie 
First name Ilse 
Address line 1Dr. Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org 
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