Study identification

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

Contact details

Clinical Disclosure Officer Novartis

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceuticals
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)