Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)
Other

If ‘other’, further details on the scope of the study

Awareness levels of risks and safety

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cross-sectional
Other

Non-interventional study design, other

Online survey
Study drug and medical condition

Medical condition to be studied

Acute lymphocytic leukaemia
Population studied

Short description of the study population

A survey of US pharmacists and nurses who have dispensed, prepared, and administered BLINCYTO therapy in the past 12 months. The study also included healthcare professionals who have been part of previous assessments at 18 months, 3 years, and 5 years after BLINCYTO launch.
Inclusion criteria:
• Inclusion criteria include HCPs, defined as nurses (RNs, BSNs), and hospital and/or home healthcare pharmacists who have dispensed, prepared and/or administered BLINCYTO therapy to patients outside of the clinical trial setting in the past 12 months.
• HCPs who have been part of previous assessments (at 18 months, 3 years, and 5 years after the launch of BLINCYTO) will also be eligible to participate.

Exclusion criteria:
• HCPs or their immediate family members (eg, spouse, children, and/or parent) who are or were employed by Amgen, Naxion, or the FDA will be excluded from participation.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)

Estimated number of subjects

200
Study design details

Main study objective

Evaluate the awareness and understanding of the preparation and administration errors associated with BLINCYTO use among pharmacists who have prepared BLINCYTO, and nurses who have administered BLINCYTO.

Outcomes

Awareness of the risk of preparation and administration errors associated with use of BLINCYTO.

Data analysis plan

Separate analyses will be performed for nurses and pharmacists, as well as a pooled analysis of the two groups to assess the participants’ understanding of the preparation and administration errors associated with the use of BLINCYTO. Categorical variables will be summarized using frequencies and proportions while quantitative data will be summarized using means and standard deviation for normally distributed data and medians and interquartile range for skewed data. For each survey question, the proportion and 95% confidence interval (CI) of each response option including the ‘not sure’ and ‘I routinely look it up’ response categories will be reported. For each knowledge question, the proportion of HCPs selecting the correct response and corresponding 95% CI will be calculated. Results will be presented for each HCP type separately, as well as pooled.