Trade-offs between benefits and harms of drugs: a stated preference study with adult patients with cancer in Europe (Patient preferences)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Patient preferences
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Neoplasm
• Additional medical condition(s):
  Common and rare cancer types

Population studied

• Short description of the study population:
  A survey of patients with cancer in Europe to determine the heterogeneity in treatment preferences.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with cancer
• Estimated number of subjects:
  900

Study design details

• Main study objective:
  1)To identify and describe PP relating to benefits and harms of cancer drugs in patients with both common and rare cancer types 2. To identify and describe the PP towards key endpoints used traditionally to assess the efficacy and safety of oncology drugs in patients with both common and rare cancer types
• Outcomes:
  To assess attribute-levels of stated preferences. To determine the extent to which patients’ heterogeneous characteristics are associated with stated preferences.
• Data analysis plan:
  The primary objective is aimed at identifying and describing the cancer PP about benefits and harms of cancer drugs and to understand the trade-offs between factors leading to PP with the main method, DCE. For this objective, we propose using Bayesian multinomial logistic regression (MNL) models reporting odds ratio’s and 95% confidence intervals. Attribute-levels will be estimated relative to a reference level for each attribute. The reference level will be selected based on the attribute-level having the lowest parameter estimate. The analysis of preferences of patients towa

Documents

Study results

EMA patient preferences on benefits and harms of cancer drugs - Final Report v1.0 03May