Healthcare Providers’ Awareness of the Risks and Safety Associated With BLINCYTO® use: A 2021 REMS Assessment Survey (20210065)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48306
• EU PAS number:
  EUPAS41626
• Study ID:
  48306
• Official title and acronym:
  Healthcare Providers’ Awareness of the Risks and Safety Associated With BLINCYTO® use: A 2021 REMS Assessment Survey (20210065)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  An online cross-sectional survey will be conducted among pharmacists and nurses who have dispensed, prepared and/or administered BLINCYTO in the United States (US) in the past 12 months outside the clinical trial setting. Previous similar surveys were conducted at 18 months, 3 years and 5 years after the launch of BLINCYTO. This cross-sectional survey is being conducted 7-years after the launch of BLINCYTO in the US. A list of health care providers (HCPs) targeted by the Risk Evaluation and Mitigation Strategy (REMS) Program will be matched to the survey vendor’s Panels and/or other target sources to determine a list of respondents. The main data collection method for this assessment will be online surveys. Before actual data collection, Naxion will conduct telephone-assisted online pilot surveys with appropriate HCPs on the proposed survey questions. The findings from the pre-test will be used to improve the survey instrument and generate a final document for the survey.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 22/03/2021

Actual: 22/03/2021

Study start date

Planned: 20/09/2021

Actual: 14/09/2021

Data analysis start date

Planned: 20/10/2021

Actual: 11/10/2021

Date of interim report, if expected

Actual: 15/10/2021

Date of final study report

Planned: 03/12/2021

Actual: 19/07/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20210065 Public Redacted Protocol Ver 1.0 English

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only