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

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

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Contact details

Olaf Klungel

Study contact

[e-mail]

Nicholas Hunt

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 01/09/2019

Actual: 01/09/2019

Data collection

Planned: 01/06/2023

Date of final study report

Planned: 01/10/2023

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