Pan European Multi-Database Bladder Cancer Risk Characterisation Study

Study identification

• EU PAS number:
  EUPAS3626
• Study ID:
  19338
• Official title and acronym:
  Pan European Multi-Database Bladder Cancer Risk Characterisation Study
• DARWIN EU® study:
  No
• Study countries:
  Finland

  Netherlands

  Sweden

  United Kingdom
• Study description:
  This observational study is being undertaken to further assess the association between pioglitazone use and bladder cancer risk among patients with type 2 diabetes mellitus in four European countries: Finland, Netherlands, Sweden, and United Kingdom.
• Study status:
  Finalised

Research institutions and networks

Institutions

EPID Research Oy

Clinical Practice Research Datalink (CPRD)

United Kingdom

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Global Database Studies, IQVIA

Czechia

Finland

Germany

Slovakia

Spain

Study timelines

Date when funding contract was signed

Planned:30/03/2012

Actual:30/03/2012

Study start date

Planned:30/07/2013

Actual:29/07/2014

Date of final study report

Planned:30/09/2016

Actual:30/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Global Research & Development Centre (Europe) Ltd

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)