Study of Operating characteristic of Bayesian methods that borrow treatment effects

Study type

• Study type:
  Not applicable
• Scope of the study:
  Other
• If ‘Not applicable’, further details on the study type:
  Assessment of Bayesian statistical methods, Literature review, Simulation study
• If ‘other’, further details on the scope of the study:
  Assessment of Bayesian statistical methods

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  0

Study design details

• Main study objective:
  (1) Review and evaluate methods for dynamic borrowing (2) Provide a clear mathematical specification of each model identified (3) Evaluate and compare (via simulations) performance of such methods along the pre-defined OCs in various common scenarios (4) Synthesize and disseminate overall conclusions and recommendations
• Data analysis plan:
  Not applicable

Documents

Study, other information

EMA_preliminary_study_plan_D2_final