Systematic Review and meta-analysis of PASS Studies Assessing the Effectiveness of Risk Minimisation Measures

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23435
• EU PAS number:
  EUPAS23245
• Study ID:
  23435
• Official title and acronym:
  Systematic Review and meta-analysis of PASS Studies Assessing the Effectiveness of Risk Minimisation Measures
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Spain

  United Kingdom
• Study description:
  Risk minimisation measures are designed to mitigate potentially manageable risks of medicines. The effectiveness of these measures is uncertain. This cumulative systematic review and meta-analysis of PASS studies conducted to evaluate the effectiveness of risk minimisation studies provides data upon which to assess the future role of these studies.
• Study status:
  Ongoing

Research institution and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Bayer AG

Bayer Epidemiology Berlin

Study timelines

Date when funding contract was signed

Actual: 28/03/2016

Study start date

Actual: 28/03/2016

Date of final study report

Planned: 25/05/2018

Sources of funding

Other

More details on funding

OXON Epidemiology

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable