Quantitative Testing of Healthcare Provider Knowledge about YESCARTA® (axicabtagene ciloleucel) Risk Minimisation Measures

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assess HCPs’ awareness and knowledge of the routine and additional RMMs addressing the key important identified risks associated with the use of Yescarta and their understanding of the handling and administration of Yescarta
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  YESCARTA

Population studied

• Short description of the study population:
  The survey questionnaire will collect data from HCPs from qualified sites in Europe who prescribe, dispense, handle or administer Yescarta or manage patients experiencing Yescarta related ADRs; Inclusion Criteria ; - The study population will be comprised of HCPs in selected countries who have received training on the educational materials and prescribe, dispense, handle or administer Yescarta or manage patients experiencing Yescarta related ADRs. ; Exclusion Criteria ; - HCPs who participated in qualitative pre-testing of the Yescarta survey. ; - HCPs who confirm whether they and/or any of their immediate family members ever worked for Kite Pharma, Inc., Gilead Sciences, Inc., ICON, or the EMA.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1617

Study design details

• Main study objective:
  The primary study objective was to assess awareness and knowledge of the routine and additional RMMs addressing the key important identified risks associated with the use of Yescarta, and their understanding of the handling and administration of Yescarta.
• Outcomes:
  Measured HCPs' knowledge of known important identified risks associated with Yescarta, Assessed whether HCPs understood 1) how to identify/treat cytokine release syndrome (CRS) or serious neurologic adverse reactions, 2) understood the correct way of handling/method of administration of Yescarta, 3) were aware of patient alert card (PAC), distributed PAC, informed patients about the PACs' content.
• Data analysis plan:
  Responses to questions for all completed surveys were analysed using descriptive statistics. HCPs' knowledge was evaluated and expressed as proportions or scores. The results were presented overall, as well as by country and HCP specialty. Categorical variables were described by the number and proportion in each category. Frequency point-estimates with two-sided 95% CIs using the binomial distribution were constructed to describe the proportion of HCPs aware of specified risks. On key questions identified as being essential to measure HCP knowledge of the additional RMMs an acceptable level of knowledge was set at 80%. Missing data for each variable were reported. Data were presented by means of summary tables. The numbers of invitees, respondents and non-responders were recorded, and the response rates were reported overall, by country, HCP's responsibility and HCP's speciality. Analyses was performed according to pre-specified statistical analysis plan.

Documents

Study results

KT-EU-471-0116-csr-body final_f-redact