A Post-Authorisation Safety Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training in Europe

Study identification

• EU PAS number:
  EUPAS24735
• Study ID:
  26709
• Official title and acronym:
  A Post-Authorisation Safety Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training in Europe
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Italy

  Netherlands

  Spain
• Study description:
  This study, designed in response to requests from EMA, will assess effectiveness of the electronic training programme (ETP) in clinical practice by determining the diagnostic accuracy of the visual image interpretations made by clinical readers (i.e. readers who mainly interpret nuclear medicine images in clinical practice rather than in research) in European countries where VIZAMYL™ is commercially available and where high use is expected during the study period. Each reader will interpret images from his/her site, for a total of at least 200 images across all sites. The standard of truth (SOT) will be the majority blinded visual interpretation of 5 expert readers who will independently review the same ≥200 images.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 15 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:04/09/2018

Actual:12/10/2018

Study start date

Planned:10/10/2018

Actual:26/10/2018

Date of final study report

Planned:09/04/2020

Actual:16/03/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GE HealthCare

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable