Survey to Evaluate the Effectiveness of Risk Minimisation Measures for Atezolizumab Use in the European Union

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39417
• EU PAS number:
  EUPAS21920
• Study ID:
  39417
• Official title and acronym:
  Survey to Evaluate the Effectiveness of Risk Minimisation Measures for Atezolizumab Use in the European Union
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Italy

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a multi-country, one-wave, cross-sectional physician survey to evaluate the effectiveness of additional Risk Minimisation Measures (aRMM) for atezolizumab use, covering receipt of, understanding and use, knowledge and behavior among physicians, and in particular aRMM effectiveness in informing physicians to recognize and manage immune-related adverse drug reactions (irADRs). The online survey questionnaire, comprising multiple-choice and true/false questions, will be conducted in several European countries where atezolizumab has been launched.
• Study status:
  Finalised

Research institutions and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Multiple centres: 300 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 12/10/2018

Actual: 12/10/2018

Study start date

Planned: 29/04/2019

Actual: 30/04/2019

Date of final study report

Planned: 06/07/2020

Actual: 26/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche Ltd

Study protocol

Initial protocol

WO40486_Protocol_11 Dec 2018_Redacted

Updated protocol

Prot WO40486 Tecentriq v1_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)