An assessment of physician knowledge and understanding of the risks of vandetanib (Caprelsa®) within the European Union

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29466
• EU PAS number:
  EUPAS4242
• Study ID:
  29466
• Official title and acronym:
  An assessment of physician knowledge and understanding of the risks of vandetanib (Caprelsa®) within the European Union
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Denmark

  Finland

  France

  Germany

  Greece

  Ireland

  Italy

  Luxembourg

  Netherlands

  Norway

  Poland

  Slovakia

  Spain

  Sweden

  United Kingdom
• Study description:
  Caprelsa was approved for use in the European Union in 2012. At the time of approval it was agreed that AstraZeneca would distribute an educational pack to potential prescribers of Caprelsa to support understanding of the benefit: risk profile of the product.Prior to launch in each EU Member State, AstraZeneca was required to agree with each national competent authority:• The final content and format of the educational material • The physician distribution list for the educational pack (to be used at the time of launch and thereafter).To assess the effectiveness of the educational material, AstraZeneca also committed to implement a survey of prescribers and potential prescribers of Caprelsa.Therefore, a yearly survey will be performed in each country in the European Union twelve months after Caprelsa is launched and will run for three consecutive years. The survey will be a self-administered, internet-based questionnaire accessed through a secure website.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Actual: 01/05/2013

Study start date

Planned: 02/09/2013

Actual: 18/09/2013

Date of final study report

Planned: 01/12/2018

Actual: 22/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

Final Caprelsa prescriber survey protocol (2) (2)

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)