Emulating target trials using observational studies: use case in OptumLabs (OPERAND @ Brown U)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Methodological assessment

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  WARFARIN

  LIRAGLUTIDE

  METFORMIN

  GLIMEPIRIDE
• Medical condition to be studied:
  Atrial fibrillation

  Diabetes mellitus inadequate control

Population studied

• 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:
  99999

Study design details

• Main study objective:
  The purpose of this study to replicate two previously published randomized controlled trials of pharmacological products that were used as the basis of marketing approval by the FDA, the ROCKET Atrial Fibrillation study and the LEAD-2 study.
• Outcomes:
  stroke & embolism for the ROCKET emulation, change in A1C at the end of the study for the LEAD-2 emulation
• Data analysis plan:
  assessment of effectiveness using causal inference methods in observational data, comparison of alternative statistical methods