Study identification

PURI

https://redirect.ema.europa.eu/resource/49902

EU PAS number

EUPAS47588

Study ID

49902

Official title and acronym

Implementation of EU risk minimisation measures for medicinal products in clinical guidelines

DARWIN EU® study

No

Study countries

Denmark
Greece
Latvia
Netherlands
Portugal
Slovenia

Study description

This project aims to describe and understand the role of healthcare professional associations and public bodies involved in the production of clinical guidelines and the dissemination of emergent safety concerns. The implementation of product specific risk minimization measures (RMMs) in five disease priority areas into clinical guidelines will be assessed in six EU Member States (Denmark, Greece, Latvia, Netherlands, Portugal, Slovenia). A multiple-case study design will be applied, using document content analysis of clinical guidelines combined with qualitative semi-structured interviews with key informants from organizations that produce guidelines as well as representatives from national competent authorities (NCAs). The methodology involves three components which will be divided over three work packages (WPs): WP1 “Mapping of relevant organisations”, WP2 “Document collection and analysis of clinical guidelines” and WP3 “Key Informant Interviews”. Findings will be analysed by country, therapeutic area, special population (pregnancy, elderly) and type of health care provider (primary/secondary care). The knowledge generated by the three WPs will provide evidence needed to produce recommendations for regulators to engage with healthcare professional bodies and other responsible parties to strengthen the role to be played by clinical guidelines in RMMs implementation, outlining feasible concrete steps that EMA and NCAs could consider.

Study status

Finalised
Research institution and networks

Institutions

University of Copenhagen Denmark, Riga Stradins University Latvia, Democritus University of Thrace Greece, Rijksinstituut voor Volksgezondheid en Milieu (RIVM) Netherlands

Networks

Contact details

Helga Gardarsdottir

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

D1_SC01_L4.02_Studyplanning_v1.0Final

English (834.06 KB - PDF)View document
Updated protocol

D2_ROC04_Studyprotocol_v4.2

English (1.38 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable