Study identification

PURI

https://redirect.ema.europa.eu/resource/29944

EU PAS number

EUPAS29415

Study ID

29944

Official title and acronym

Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND)

DARWIN EU® study

No

Study countries

United States

Study description

The OPERAND program will study the conditions under which it may be possible to replicate the findings of two previously published randomized clinical trials (RCTs) with observational data. Such evidence would set the stage for improving confidence in estimates of treatment effectiveness for patient populations beyond those originally studied in RCTs. Two project teams will independently replicate the same two trials, the ROCKET Atrial Fibrillation and the LEAD-2 studies, using their own methodology. If the data confirms the previously published RCT results, the teams will extend the use of the data to estimate the ATE for the populations actually treated within the original indication. All analyses will be conducted using the OptumLabs Data Warehouse (OLDW)—a database of more than 120 million lives of claims data linkable to over 50 million lives of electronic medical record data.

Study status

Ongoing
Research institutions and networks

Institutions

Harvard Pilgrim Health Care Institute Boston, MA, USA, Brown University Providence, RI, USA, OptumLabs, Multiregional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

Contact details

Darren Toh

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen, AstraZeneca, Pfizer, UCB, Sanofi, Merck
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable