Physician Survey to Assess the Effectiveness of the Additional Risk Minimisation Measures (aRMM) for KIMMTRAK® (tebentafusp) (IMCR-0001)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Population studied

• 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:
  250

Study design details

• Main study objective:
  Physicians’ understanding of the important safety information detailed in the Treatment Guide for Healthcare Professionals to minimise the severity of CRS with KIMMTRAK.
• Outcomes:
  This study will assess the following: a) Physicians’ understanding of the important safety information detailed in the Treatment Guide for Healthcare Professionals to minimise the severity of CRS with KIMMTRAK. b) Healthcare professionals’ distribution of the Patient Guide to patients treated with KIMMTRAK.
• Data analysis plan:
  Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% CIs will be calculated for responses to questions that address the survey objectives (i.e. excluding demographic questions). Survey data will be analysed overall and stratified by country. Responses will be categorised as “Correct response” and “Incorrect response”.