Study identification

PURI

https://redirect.ema.europa.eu/resource/42388

EU PAS number

EUPAS41726

Study ID

42388

Official title and acronym

Drug utilisation studies using data mapped to the OMOP Common Data Model: a proof of concept study assessing respiratory drug use in patients with asthma or COPD

DARWIN EU® study

No

Study countries

Netherlands
United Kingdom
United States

Study description

The use of healthcare data, generated through the delivery of normal clinical care is increasingly being proposed as a source of evidence to support not only drug development and regulatory decision-making but also to understand the physiology and pathogenesis of diseases. Use of multiple electronic health care databases is important not only to increase sample size but also to investigate country specific differences, differences by type of databases (e.g. primary vs. secondary care) or to replicate findings. One of the challenges however are the differences between the databases with regard to the underlying structures and semantic mapping. A common data model could help harmonise healthcare data across multiple data sets and provide a mechanism to allow the conduct of multi-database, international studies. The European Health Data and Evidence Network (EHDEN) project (https://www.ehden.eu/) is an international project supported by the Innovative Medicines Initiative (IMI) aiming to standardize health care data to the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) and to develop and implement tools to facilitate research on large electronic health care databases. One of the objectives of the EHDEN project is to test existing methodologies but also to develop new methodologies and analytical tools to conduct (pharmaco)epidemiological research using electronic health care databases mapped to the OMOP CDM. To investigate the validity and functionality of this approach, we want to conduct a drug-utilisation study using EHR data. As proof of concept study we want to conduct a drug utilisation studies on respiratory drug use in patients with asthma and chronic obstructive pulmonary disease (COPD). This research is important and relevant as asthma and COPD are prevalent conditions, primarily treated in primary care.

Study status

Ongoing
Research institutions and networks

Institutions

NDORMS Oxford - UK

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme

More details on funding

IMI - EHDEN
Study protocol
Initial protocol

DUS_asthmaCOPD_full protocol_2july2021

English (763.4 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable