Study identification

PURI

https://redirect.ema.europa.eu/resource/104220

EU PAS number

EUPAS104219

Study ID

104220

Official title and acronym

Comparing Database Harmonisation Methods Applied to Real-World Electronic Healthcare Data

DARWIN EU® study

No

Study countries

United Kingdom

Study description

The use of multiple health databases is the preferred method for generating evidence on the safety and effectiveness of medicines, compared to the use of a single database. However, these larger studies have an additional number of complexities. These are in part due to the heterogeneity amongst data sources, a challenge only amplified when using internationally distributed databases. Harmonisation methods such as the use of a common protocol (CP) and/or a common data model (CDM) can improve consistency of findings across databases. Here we will compare different harmonisation methods by comparing the subsequent effect estimates and summary measures in an applied internationally distributed database setting.

Study status

Planned
Research institution and networks

Institutions

Contact details

Nicholas Hunt

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

PhD project
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable