Study identification

EU PAS number

EUPAS1000000615

Study ID

1000000615

Official title and acronym

DARWIN EU® - Drug utilisation study of prescription opioids

DARWIN EU® study

Yes

Study countries

Croatia
Finland
Germany
Hungary
Italy
Portugal
Sweden

Study description

A drug utilisation study of prescription opioids based on a Common Data Model (CDM) will provide useful information on the trends of prescription opioids and the characteristics of prescription opioid users in Europe.
By supplementing the conventional European monitoring systems for aggregated opioid consumption, this study will offer detailed data on these drugs incl. their strength and route of administration, thereby enabling well-informed, evidence-based decision-making in addressing this multifaceted topic.
Following the completion of P2-C1-002 (EUPAS105641) and P3-C2-002 (EUPAS1000000479) (see section 'Other study identifiers'), EMA requested a routine repeated study to include additional databases and more recent data.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Amy Lam

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable