(A-197) Linkage of clinical trial data to real-world data (RWD) sources: A scoping review

Background: 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 this RWD is linked at the participant level, it can supplement active data collection in trial and provide deeper insights into the benefits, risks, and costs of treatments.

Objectives: 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 medical records, 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. We excluded opinion pieces, study protocols, or studies that involved interventions other than medications, dietary supplements, vaccines, devices, procedures, or diagnostics (e.g. behavioral interventions). 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 in the results, including 42 medication, vaccine, and dietary supplement trials (59.2%) and 29 device, procedure, or diagnostic 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. Most studies obtained consent for linkage prospectively as part of the main trial or received a Waiver of Authorization from ethical review boards. Our findings demonstrate the feasibility and provide an overview of the use cases for linking trials to RWD.