Statistical methods for time-to-event endpoints with non-proportional hazards in clinical trials pivotal for benefit risk decision making

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  Assessment of statistical methods, Literature review, Review of EMA EPARs/Scientific Advices, Simulation Study
• If ‘other’, further details on the scope of the study:
  Assessment of statistical methods

Population studied

• Short description of the study population:
  N/A
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • 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)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  (1) To identify available statistical methods for the analysis of time-to-event endpoints in the presence on non-proportional hazards. (2) to assess the statistical properties of these methods (3) to assess the regulatory acceptability of these methods for clinical trials that are pivotal for drug development and benefit-risk assessment and derive recommendations
• Data analysis plan:
  Not applicable