YERVOY Risk Minimisation Tool Evaluation Survey

Study identification

• EU PAS number:
  EUPAS4924
• Study ID:
  39673
• Official title and acronym:
  YERVOY Risk Minimisation Tool Evaluation Survey
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  Finland

  France

  Germany

  Ireland

  Italy

  Netherlands

  Norway

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a non-interventional observational cross-sectional study using HCP and Patient surveys. In addition the results of the surveys (awareness, knowledge and behaviours) will be co-analysed with the rate of ADRs of interest (irARs) observed from standard pharmacovigilance (spontaneous reports) to explore if irAR reporting rates correlate with knowledge of the risks addressed by the RM tools. The surveys are not intended as a mechanism to collect AEs nor are they intended to result in minimising the numbers of AEs. The surveys are designed to evaluate HCP’s and patient’s awareness, utilisation, knowledge of irARs and behaviours (via scenarios).
• Study status:
  Finalised

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

Multiple centres: 80 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:22/12/2011

Study start date

Planned:01/05/2014

Actual:01/05/2014

Data analysis start date

Planned:30/09/2014

Date of final study report

Planned:28/11/2014

Actual:04/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb Company

Regulatory

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