Program to evaluate the Tasigna (nilotinib) educational materials: survey to patients and physicians in five EU countries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28196
• EU PAS number:
  EUPAS6073
• Study ID:
  28196
• Official title and acronym:
  Program to evaluate the Tasigna (nilotinib) educational materials: survey to patients and physicians in five EU countries
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  The objective of the proposed survey is to evaluate the effectiveness of the educational material for healthcare professionals and patients/caregivers used as part of the Tasigna® risk management plan. Specifically:•to evaluate physician’s receipt and review as well as their understanding of the educational material •to evaluate the physician’s assessment of the effectiveness of the educational materials, as tools to convey important safety information to physicians who prescribe Tasigna.•to assess patients' understanding of the patient educational material, to confirm that patients have received and reviewed as well as comprehended the material.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 30/11/2013

Actual: 09/01/2014

Study start date

Planned: 09/10/2014

Actual: 08/12/2014

Data analysis start date

Planned: 31/12/2015

Actual: 31/12/2015

Date of final study report

Planned: 31/12/2015

Actual: 27/04/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceuticals

Study protocol

Initial protocol

AMN107A2001--protocol_Redacted

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)

Other study registration identification numbers and links

CAMN107A2001