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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29518
• EU PAS number:
  EUPAS29517
• Study ID:
  29518
• Official title and acronym:
  Emulating target trials using observational studies: use case in OptumLabs (OPERAND @ Brown U)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  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. For each trial, the initial objective is to mimic the inclusion/exclusion criteria, endpoint definitions, exposure windows, and other design features of each study as closely as possible. Then, using a series of multivariate methods, average treatment effect (ATE) estimates will be produced and compared to those reported in the original publication.
• Study status:
  Planned

Research institutions and networks

Institutions

Brown University

Study timelines

Date when funding contract was signed

Planned: 01/04/2019

Study start date

Planned: 01/04/2019

Date of final study report

Planned: 31/12/2019

Sources of funding

Other

More details on funding

OptumLabs

Study protocol

Initial protocol

OPERAND Research Protocol_Dahabreh_Brown & Harvard 06182019

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable