Effectiveness evaluation survey for Eurartesim

Study identification

• EU PAS number:
  EUPAS8304
• Study ID:
  33853
• Official title and acronym:
  Effectiveness evaluation survey for Eurartesim
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  The European Medicines Agency (EMA) has requested Sigma-Tau to provide all physicians who are expected to prescribe or use Eurartesim with a healthcare professional educational pack. The EMA has requested Sigma-Tau to perform an Effectiveness survey in order to further assess physician understanding of this education material.This study will be conducted in 3 European countries by physicians who are expected to prescribe or use Eurartesim for the treatment ofmalaria. To study will ascertain the physician understanding of the education material provided about Eurartesim, in terms of drug indication, prescription modalities, administration modalities, high-risk patients, and potential side effects.The survey will be conducted respectively 12 months and 24 months after Eurartesim education material is delivered to the Physicians by the Sponsor. Physicians will be selected among a list of approximately 300 physicians per country, provided by the Sponsor.Approximately 60 Physicians per country are expected to participate.The following selection process will be conducted in each country respectively 12 months and 24 months after Physicians received education material:- A recruitment mail containing the study summary and a participation form will be sent to all Physicians.- Physicians will be asked to send back the completed participation form to Mapi. Characteristics of physicians, and if applicable, reason for non participation will be collected on the participation form.- Non-respondent Physicians will be contacted by telephone by Mapi, to know if they agree or not to participate in the survey.- The survey questionnaire will be administered by Mapi by phone to the Physicians selected for the survey and willing to participate.The results will be analysed according to the Statistical Analysis Plan written for the study.
• Study status:
  Finalised

Research institutions and networks

Institutions

ICON Commercialisation & Outcomes

Germany

Ireland

Multiple centres: 360 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:01/09/2011

Actual:01/09/2011

Study start date

Planned:01/09/2013

Actual:02/09/2013

Data analysis start date

Planned:01/04/2014

Actual:01/04/2014

Date of interim report, if expected

Planned:30/06/2014

Actual:01/07/2014

Date of final study report

Planned:30/06/2015

Actual:26/06/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sigma Tau

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)