Study identification

PURI

https://redirect.ema.europa.eu/resource/39673

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

Multiple centres: 80 centres are involved in the study

Contact details

Randip Kahlon

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
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