Study identification

EU PAS number

EUPAS38096

Study ID

50298

Official title and acronym

Patient and Prescriber Survey: Effectiveness measures to investigate awareness, knowledge and adherence to the Risk Minimisation Measures (RMMs) of the Pregnancy Prevention Program (PPP) for Oral Retinoids (Acitretin, Alitretinoin, and Isotretinoin)

DARWIN EU® study

No

Study countries

France
Germany
Greece
Norway
Poland
Spain
United Kingdom

Study description

This survey aims to assess the effectiveness of the updated risk minimisation measures (RMMs) among female oral retinoid patients who are of childbearing potential and their prescribers and to assess patients’ and prescribers’ (HCPs’) awareness and knowledge of and adherence to the pregnancy prevention programme (PPP). Primary objective: to assess the effectiveness of the PPP based on pre-defined success thresholds for PPP awareness, knowledge, and adherence in HCPs and patients. Secondary objectives: (1) to assess HCPs’ and patients’ awareness of the updated PPP (2) to assess HCPs’ and patients’ knowledge of the risks and RMMs associated with the use of oral retinoids (3) to assess whether HCPs and patients adhere to the RMMs of the updated PPP

Study status

Finalised
Research institutions and networks

Institutions

Real World Solutions, IQVIA
Netherlands
United Kingdom (Northern Ireland)
First published:
22/03/2024
Institution Other ENCePP partner

Contact details

Birgit Ehlken

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

A Consortium of Marketing Authorization Holders for oral retinoids
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)