Survey to Evaluate the Effectiveness of Risk Minimisation Measures for Atezolizumab Use in the European Union

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ATEZOLIZUMAB

Population studied

• Short description of the study population:
  Physicians who prescribed or managed at least one patient with Tecentriq intheir routine clinical practice.; ; Eligibility Criteria; Physicians must meet the following criteria for study inclusion:; • Oncologist, pulmonologist or urologist who has prescribed or managed at least one patient with atezolizumab in routine clinical practice.; Physicians who meet any of the following criteria will be excluded from the study:; • Physician used atezolizumab only in clinical trials or in an expanded access programme.; • Physician refuses to participate.; • Physician is a current or former employee of Roche or delegates.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Urothelial cancer patients
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The main objective of the study is to assess the receipt of the atezolizumab HCP Guide and Patient Alert Card (PAC) for the target physician population and to assess the level of knowledge of key messages related to Immune-related Adverse Drug Reactions (IrADRs) outlined in the atezolizumab HCP Guide and PAC.
• Outcomes:
  Primary Outcomes are as follows:- Percentage of respondents that report having received the HCP Guide and PAC.- Percentage of respondents that correctly answered each knowledge sub-question. An individual physician score will be calculated as the proportion of all knowledge sub-questions with correct responses. Secondary Outcomes are as follows:- Percentage of respondents that report having understood the HCP Guide.- Percentage of respondents that report having read or used the HCP Guide and PAC. - Percentage of respondents that correctly answered each behavior sub-question. An individual physician score will be calculated as the proportion of all behavior sub-questions with correct responses.
• Data analysis plan:
  Statistical analyses will be mainly descriptive. Continuous variables will be described by their number (of valid cases, of missing values), mean, standard deviation, median, interquartile range, minimum and maximum. Categorical variables will be described as the total number and relative percentage per category. Confidence intervals of 95% will be evaluated, when relevant. The number of missing data will be indicated. Since missing values are expected to be few and distributed at random, no replacement or imputation will be performed. Missing values will not be considered in the denominators for proportions. For physician questionnaire measures, results will be stratified by country and physician’s specialty. Results may be weighted according to the distribution of physicians in the general population by country and specialty.