Linkage of Clinical Trial Data to Routinely Collected Data Sources
This study found that the linkage of patients' clinical trial data to routinely collected data has been implemented in several trials for various use cases and that most studies obtained consent for linkage prospectively as part of the main trial or received a waiver of authorization from ethical review boards. These findings demonstrate the feasibility and provide an overview of the use cases for linking trials to routinely collected data.
Authors
- Ben McConnochie
- Mehmet Burcu (ORCID: https://orcid.org/0000-0003-4572-0987)
- Mehdi Najafzadeh (ORCID: https://orcid.org/0000-0003-4503-1057)
- Elisabetta Patorno (ORCID: https://orcid.org/0000-0002-8809-9898)
- Thomas P. Vaccaro
- Ella Kim (ORCID: https://orcid.org/0000-0002-8891-6309)
- Ana B. Oromendia
Institutions
- Brigham and Women's Hospital (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Harvard University (US)
- Medidata (United States) (US)
Publication Details
- Journal
- JAMA Network Open
- Published
- 2025-04-29
- DOI
- https://doi.org/10.1001/jamanetworkopen.2025.7797
- Citations
- 6
- Primary Topic
- Meta-analysis and systematic reviews
- Type
- article
- Field-Weighted Citation Impact
- 8.39
Funders
- Patient-Centered Outcomes Research Institute
- National Institute of Diabetes and Digestive and Kidney Diseases