A review of studies evaluating the effectiveness of risk minimisation measures in Europe using the European Union electronic Register of Post-Authorization Studies.

ABSTRACT:

Purpose

An important element of risk management is the planning and implementation of risk minimisation measures (RMMs) and the evaluation of their effectiveness by process or outcome indicators. The aim of this review is to summarize the characteristics of risk minimisation (RM) effectiveness studies in Europe and provide an overview of RMMs and their effectiveness.

Methods

This was a qualitative review of RM effectiveness studies in the European Union electronic Register of Post-Authorization Studies (EU PAS Register); data extracted included study design, population, sample size, data sources, drug information, RMMs, study period, indicators, and their reported effectiveness.

Results

Of the 872 records in the EU PAS Register, 19 studies evaluating the effectiveness

SUBMITTER: Vora P 

PROVIDER: S-EPMC6055865 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature