Status: Planned First registered on: 16/11/2020
Last updated on: 16/11/2020
1. Study identification
EU PAS Register NumberEUPAS38096
Official titlePatient 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)
Study title acronym
Study typeOther: Survey
Brief description of the studyThis 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
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research groupReal World Evidence
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Toussi
First name Massoud
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Greece
Norway
Poland
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/06/2018
Start date of data collection31/03/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report31/03/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesA Consortium of Marketing Authorization Holders for oral retinoids100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Toussi
First name Massoud
Address line 1Tour D2
Address line 217 bis Place des Reflets 
Address line 3 
CityCourbevoie 
Postcode92090 
CountryFrance
Phone number (incl. country code)33607966650 
Alternative phone number 
Fax number (incl. country code) 
Email address massoud.toussi@iqvia.com
Public Enquiries
Title Ms 
Last name Dwan 
First name Bernadette 
Address line 1Kirschgartenstrasse 14 
Address line 2 
Address line 3 
CityBasel 
Postcode4051 
CountrySwitzerland 
Phone number (incl. country code)41754335843 
Alternative phone number 
Fax number (incl. country code) 
Email address bernadette.dwan@iqvia.com 
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