Survey of Physicians, Pharmacists, and Nurses Involved in the Prescribing, Preparation and Administration of Blincyto in Europe to Evaluate the Effectiveness of Additional Risk Minimization Measures (20150163)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32764
• EU PAS number:
  EUPAS16626
• Study ID:
  32764
• Official title and acronym:
  Survey of Physicians, Pharmacists, and Nurses Involved in the Prescribing, Preparation and Administration of Blincyto in Europe to Evaluate the Effectiveness of Additional Risk Minimization Measures (20150163)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  Educational materials targeting patients /caregivers and HCPs (physicians, nurses and pharmacists) have been implemented to help minimize the risks of neurological events and the potential for medication errors (MEs). A survey of physicians, nurses and pharmacists will be conducted to help assess whether the processes put in place for the Blincyto educational efforts are effective in achieving a sufficient level of receipt of the materials, and knowledge and behavior around key messages in the materials
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 25 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 02/09/2016

Actual: 02/09/2016

Study start date

Planned: 28/04/2017

Actual: 28/04/2017

Data analysis start date

Planned: 21/01/2019

Actual: 09/01/2019

Date of final study report

Planned: 29/11/2019

Actual: 13/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

20150163 Protocol Ver 1 0 2016-10-18 English redaction_Marked

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)