Review of studies evaluating the effectiveness of risk minimisation measures evaluated by PRAC (EffectiveRMM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45979
• EU PAS number:
  EUPAS45978
• Study ID:
  45979
• Official title and acronym:
  Review of studies evaluating the effectiveness of risk minimisation measures evaluated by PRAC (EffectiveRMM)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This is a systematic review of industry sponsored PASS evaluating RMM effectiveness assessed by the PRAC between 2016 and 2019. The study was conducted to provide better understanding of the types of data collected, the study designs and analytical methods used, and to provides a better understanding of those PASS where a conclusion on RMM effectiveness could be drawn in order to help improve regulatory decision-making.
• Study status:
  Finalised

Research institutions and networks

Institutions

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

Netherlands

Study timelines

Date when funding contract was signed

Planned: 03/02/2020

Actual: 03/02/2020

Study start date

Planned: 01/07/2020

Actual: 01/07/2020

Data analysis start date

Planned: 01/03/2021

Actual: 01/03/2021

Date of final study report

Planned: 01/12/2021

Actual: 01/12/2021

Sources of funding

EMA

Other

More details on funding

Utrecht University

Study protocol

Initial protocol

EUPAS_Reg_RMM_study

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable