Validation of predictors for oral anticoagulant medication choice using EMR data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16315
• EU PAS number:
  EUPAS16314
• Study ID:
  16315
• Official title and acronym:
  Validation of predictors for oral anticoagulant medication choice using EMR data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This validation study seeks to ascertain a select set of covariates in electronic medical records (EMRs) linked to a subset of patients within the insurance claims data in order to assess the potential for unmeasured confounding in observational studies based on insurance claims databases only.
• Study status:
  Planned

Research institutions and networks

Institutions

Brigham and Women's Hospital

Study timelines

Date when funding contract was signed

Planned: 01/06/2012

Actual: 01/06/2012

Study start date

Planned: 06/01/2017

Data analysis start date

Planned: 06/01/2017

Date of final study report

Planned: 30/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

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