Linkage of Clinical Trial Data to Real-World Data (RWD) Sources: A Scoping Review
Author(s)
Mehdi NajafZadeh, MA, MASc, PhD1, Ana Oromendia, PhD2, Mehmet Burcu, BA, MSc, PhD3, Ben McConnochie, MSc4, Ella Kim, BSc2, Elisabetta Patorno, MD, DPhil5.
1Medidata Solutions, Boston, MA, USA, 2Medidata Solutions, New York, NY, USA, 3Merck & Co., Inc., Rahway, NJ, USA, 4Medidata Solutions, London, United Kingdom, 5Div of Pharmacoepidemiology, Dep of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
1Medidata Solutions, Boston, MA, USA, 2Medidata Solutions, New York, NY, USA, 3Merck & Co., Inc., Rahway, NJ, USA, 4Medidata Solutions, London, United Kingdom, 5Div of Pharmacoepidemiology, Dep of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Presentation Documents
OBJECTIVES: Patients who participate in clinical trials generate valuable real-world data (RWD) through their routine interactions with the healthcare system before, during, and after the trial. When RWD is linked at the participant level, it can supplement active data collection in trial. We conducted a scoping review of clinical trials linked to RWD in various countries, identifying the use cases and designs of these linkage studies.
METHODS: We searched for research articles that reported the linkage of clinical trials to electronic health records, claims databases, disease registries, or vital statistics in their title or abstract. Our search covered the period from January 1, 2016, through December 30, 2023. Study eligibility and data extraction were performed independently by two reviewers to ensure the accuracy of findings.
RESULTS: Of the 990 abstracts initially screened, we reviewed the full text of 147 articles. We reported on 71 studies, including 42 trials of medications, vaccines, or dietary supplements (59.2%) and 29 trials of devices, procedures, or diagnostics trials (40.8%). Of these 71 studies, 23 (32.4%) were conducted in the US. In 34 studies (47.9%), consent for linkage was obtained prospectively as part of the main trial, while 33 studies (46.5%) received a Waiver of Authorization from the respective ethical review boards. The most frequent use cases of linkage to RWD were post-trial long-term follow-up (22 (25%)), capturing primary/secondary outcomes of trial (19 (21.6%)), validation of RWD outcomes (17(19.3%)), and measuring healthcare resource utilization and cost in trials (12 (13.6%)).
CONCLUSIONS: The linkage of clinical trial patients' data to RWD has been implemented for various use cases, including post-trial long-term follow-up, capturing primary or secondary outcomes, validation of RWD, and measuring healthcare resource utilization and cost in trials. Our findings demonstrate the feasibility and provide an overview of the use cases for linking trials to RWD.
METHODS: We searched for research articles that reported the linkage of clinical trials to electronic health records, claims databases, disease registries, or vital statistics in their title or abstract. Our search covered the period from January 1, 2016, through December 30, 2023. Study eligibility and data extraction were performed independently by two reviewers to ensure the accuracy of findings.
RESULTS: Of the 990 abstracts initially screened, we reviewed the full text of 147 articles. We reported on 71 studies, including 42 trials of medications, vaccines, or dietary supplements (59.2%) and 29 trials of devices, procedures, or diagnostics trials (40.8%). Of these 71 studies, 23 (32.4%) were conducted in the US. In 34 studies (47.9%), consent for linkage was obtained prospectively as part of the main trial, while 33 studies (46.5%) received a Waiver of Authorization from the respective ethical review boards. The most frequent use cases of linkage to RWD were post-trial long-term follow-up (22 (25%)), capturing primary/secondary outcomes of trial (19 (21.6%)), validation of RWD outcomes (17(19.3%)), and measuring healthcare resource utilization and cost in trials (12 (13.6%)).
CONCLUSIONS: The linkage of clinical trial patients' data to RWD has been implemented for various use cases, including post-trial long-term follow-up, capturing primary or secondary outcomes, validation of RWD, and measuring healthcare resource utilization and cost in trials. Our findings demonstrate the feasibility and provide an overview of the use cases for linking trials to RWD.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD57
Topic
Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Oncology, STA: Surgery