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Status: Finalised First registered on: 23/10/2015

Last updated on: 28/03/2018

1. Study identification

EU PAS Register NumberEUPAS11379

Official titleEvaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey and Drug Utilisation Study among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of valproate in France, Germany, Spain, Sweden and United Kingdom

Study title acronym

Study typeObservational study

Brief description of the studyEvaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey and Drug Utilisation Study among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of valproate in France, Germany, Spain, Sweden and United Kingdom

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 belongsIMS Health

Department/Research groupReal World Evidence Solutions

Organisation/affiliationIMS Health

Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go

Details of (Primary) lead investigator

Title Dr

Last name Massoud

First name Toussi

Is this study being carried out with the collaboration of a research network?

Other centres where this study is being conducted

Not applicable (single centre)

Countries in which this study is being conducted

International study

France

Germany

Spain

Sweden

United Kingdom

3. Study timelines: initial administrative steps, progress reports and final report

PlannedActual

Date when funding contract was signed30/11/201501/06/2016

Start date of data collection31/03/201531/08/2016

Start date of data analysis

Date of interim report, if expected

Date of final study report30/11/201609/05/2017

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 MAHs100

Charities

Government body

Research councils

EU funding scheme

5. Contact details for enquiries

Scientific Enquiries

Title Dr

Last name Massoud

First name Toussi

Address line 15-7 place des Pyramides

Address line 2

Address line 3

CityParis La Défense

Postcode92088

CountryFrance

Phone number (incl. country code)33-1413-51335

Alternative phone number

Fax number (incl. country code)

Email address mtoussi@fr.imshealth.com

Public Enquiries

Title Dr

Last name Massoud

First name Toussi

Address line 15-7 place des Pyramides

Address line 2

Address line 3

CityParis La Défense

Postcode92088

CountryFrance

Phone number (incl. country code)33-1413-51335

Alternative phone number

Fax number (incl. country code)

Email address mtoussi@fr.imshealth.com

11. Scope of the study

What is the scope of the study?

Drug utilisation study

Survey

Primary scope : Survey

12. Main objective(s)

What is the main objective of the study?

The objective of the survey is to measure the effectiveness of the DHPC and educational material (EM), implemented as part of risk minimisation measures, by ascertaining the proportion of targeted physicians who understood and implemented the latest prescribing conditions and safety information about valproate provided in the DHPC and EM.

Are there primary outcomes?No

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Drug utilisation study

Physicien survey

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

The statistical analysis will be conducted using the SAS® softwareV9.4on Windows™ (SAS Institute, North Carolina, USA). The statistical results of the five countries will be presented in the same report, overall, per country and per physician’s specialty group. All the analysis will be descriptive in nature and no statistical comparison will be done in this study. Continuous variables will be described by their number (of valid cases, of missing values), mean, standard deviation, and median, Q1, Q3, minimum and maximum. Categorical variables will be described as the total number and relative percentage per category. These will be the percentage per category. Free text answers to open-ended questions will be categorised by theme, listed according to the frequency. Confidence intervals of 95% will be evaluated, when relevant. The proportions of correct and appropriate answers to selected questions asked in the questionnaire will be expressed among physicians.