Alecensa Survey to Prescribers: Effectiveness Measure to Investigate the Correct Implementation of Alecensa Label Guidance by Prescribers

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:
  Survey to evaluate how HCPs understand and correctly implement the risk minimization measures for Alecensa
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE36) alectinib

  alectinib

Population studied

• Short description of the study population:
  All HCPs (i.e., oncologists and pulmonologists) in the study countries who can be identified as potential prescribers of Alecensa and have not provided their general opt out will be considered as the target population.; Inclusion criteria:; HCPs (i.e., either oncologists or pulmonologists) must meet the following criteria for study entry:; 1. HCPs must have treated patients (newly initiated or repeated administration/prescription) with ALK-positive NSCLC with Alecensa according to local label at least once in the 6 months prior to taking the survey; Exclusion criteria:; Inactive and retired HCPs (when documented information is available to identify them) will be deleted from the contact lists before randomization. HCPs who meet any of the following criteria will be excluded from study entry:; 1. HCPs who are not involved in patient treatment; 2. HCPs who may have conflicts of interest with the survey (i.e., HCPs employed by regulatory bodies, pharmaceutical industries); 3. Employment by Roche, or any research organization/vendor contracted by Roche to administer the survey
• 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:
  200

Study design details

• Main study objective:
  To assess the awareness, knowledge, and clinical practices of HCPs regarding the specific important identified risks related to Alecensa and their related minimization measures.
• Outcomes:
  Proportion of HCPs aware of the important identified risk and related minimization measures for Alecensa, 1. Proportion of HCPs knowledgeable about important risks, specific monitoring, dose modification2. Proportion of HCPs answering the clinical practice questions in compliance to the Summary of Product Characteristics (SPC)
• Data analysis plan:
  The effectiveness of risk minimization measures will be defined by the proportion of HCPs aware of the identified risk and related minimization measures for Alecensa, the proportion of HCPs knowledgeable of the important risks, specific monitoring, and dose modification of Alecensa, and the proportion of HCPs answering the clinical practice questions in the questionnaire in compliance with the summary of product characteristics.

Documents

Study results

Final CSR Synopsis, Study BO40643_redacted_A