Addressing Benefits and Misconceptions About Implementing Trial Linkage

Patients who participate in clinical trials are rarely connected to their routinely collected real-world data (RWD). Patients generate health data throughout their lives, whether it be from labs, hospital visits, pharmacy prescriptions, or health records. Data collected during clinical trials, however, typically offers just a snapshot of a patient's health at specific points in time—without incorporating the broader context that can be found in these other valuable sources of information. By linking clinical trial data with patients’ RWD, researchers can obtain a more holistic view of the participant. Trial patients’ RWD can supplement active data collection in trials and provide additional insight into the benefits, risks, and costs of treatments to help patients, physicians, and decision-makers. 

The process for trial data linkage to RWD can be implemented in the trial protocol or as a separate observational sub-study. In either approach, the steps needed for trial linkage—such as patients’ informed consent and subsequent institutional review board (IRB) approval, collecting and storing personally identifiable information (PII), and tokenization—can all be integrated into the trial-standard electronic data capture (EDC) system to minimize the burden on site investigators and staff. 

Benefits of clinical trial linkage to RWD go beyond operational efficiencies in data collection.

By linking data from various sources—including electronic health records, medical claims data, and registries—researchers can get a broader view of patients’ histories, trajectories, and outcomes. This can help the evaluation of efficacy, effectiveness, safety, and cost of drugs, medical devices, or other medical products.

There are still many misconceptions and unfamiliarities with the processes and technologies needed for implementing trial linkage to RWD at scale. Providing information and guidance on the implementation process can help companies leverage the benefits of clinical trial linkage. Adding linkage to a clinical trial may seem like an extra step in the beginning, but a successful linkage technology should be easily integrated and potentially end up expediting patients' access to valuable treatments.

Medidata evaluated implementation efforts for adding linkage—specifically Medidata Link—across various trials, sponsors, and indications. The findings ultimately showed feasibility and acceptable levels of time and effort required across stakeholders, including trial leads, data management leads, and real-world evidence leads, when it came to implementing trial linkage and benefitting from clinical trial tokenization. Some of the most common use cases observed were capturing healthcare resource utilization data, tracking patients lost to follow up, and augmenting long-term follow up.