A cross-sectional study to evaluate the effectiveness of XALKORI Therapeutic Management Guide among physician prescribing XALKORI in Europe

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18665
• EU PAS number:
  EUPAS7389
• Study ID:
  18665
• Official title and acronym:
  A cross-sectional study to evaluate the effectiveness of XALKORI Therapeutic Management Guide among physician prescribing XALKORI in Europe
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  France

  Germany

  Ireland

  Italy

  Netherlands

  Sweden

  United Kingdom
• Study status:
  Finalised

Research institution and networks

Institutions

ICON Commersialisation & Outcomes (MAPI-ICON), ICON

Germany

Multiple centres: 60 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned: 28/07/2014

Actual: 18/08/2014

Study start date

Planned: 22/09/2014

Actual: 30/09/2014

Date of final study report

Planned: 31/03/2017

Actual: 30/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Study protocol

Initial protocol

A8081049_PROTOCOL_Crizotinib Physician Survey_25March2014

Updated protocol

A8081049_PROTOCOL AMENDMENT 2_Crizotinib Physician Survey_30 March 2015 Clean_register

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)