3 Data Linkage Use Cases to Future Proof Your Clinical Trials
Access to compelling and relevant evidence is crucial to drug development, safety monitoring, and improved patient outcomes. But silos between clinical trial data (CTD) and real-world data (RWD) make it difficult to fully understand what happens to patients outside of a clinical trial.
Historically, the disconnect between CTD and RWD stems from patient privacy concerns. However, this evidence gap delays access to critical efficacy, effectiveness, safety, and utilization data—ultimately becoming a detriment to patients. For example, the fragmented nature of healthcare data has prevented a rapid and clear analysis into the impact of “long” COVID-19, as well as the actual healthcare journey and impact of Vaping-Associated Pulmonary Injury (VAPI).
Novel tokenization technologies that enable privacy-preserved data linkage are shifting the existing paradigm of clinical trials. Sponsors have begun connecting traditional CTD to RWD data sources at the patient level. RWD-enhanced CTD more holistically describes the patient’s trajectories, characteristics, and outcomes to help sponsors close critical evidence generation gaps. With a deeper understanding of patients’ diseases, treatments, and outcomes, the industry is unlocking a new frontier in evidence generation—opening up limitless applications for tracking patients lost to follow-up, contextualizing patient-reported outcomes, demonstrating treatment effectiveness and cost, and long-term safety monitoring.
How can data linkage address your organization’s specific needs? In this 4-part blog series, we discuss use cases with Medidata Link, the industry’s only scalable solution for clinical research data linkage. These sample use cases can be applied across the clinical development life cycle in a wide range of therapeutic areas. Whether you are future-proofing your clinical programs or looking to ensure the success of a single trial, Medidata Link can help every clinical trial achieve its full potential.
Use Case #1: Tracking Clinical Trial Patients Lost to Follow-Up
When a research patient is lost to follow-up (LTFU) in a clinical trial, it has significant impacts on study costs and evidence generation. Sponsors may miss key clinical endpoints that render that patient’s data near useless. In some cases, too many lost patients can be a significant detriment to generating statistically valid outputs. Linked RWD makes it possible to supplement that lost patient data, helping sponsors generate meaningful endpoints despite potential patient dropout.
Use Case #2: Quantifying Healthcare Resource Utilization
Although healthcare resource utilization (HCRU) variables are crucial endpoints needed to support payer and provider discussions, they are not usually captured in clinical trials. To support market access activities, sponsors often have to rely on extrapolating limited data or waiting years for RWD to accumulate post-commercialization. Linked CTD and RWD help illustrate the comprehensive patient pathway to delineate between different sources of cost burden. By measuring HCRU and monitoring adverse event rates, sponsors can quantify a therapy’s impact on the healthcare system—particularly in comparison to the standard of care.
Use Case #3: Long-Term Safety and Effectiveness Tracking
Post-authorization safety monitoring and post-market surveillance are critical to fully understanding the effectiveness and safety profile of therapies. But, tracking long-term outcomes after a trial is burdensome, often requiring sponsors to manually reach out to patients. Data linkage provides faster and deeper insights into trial patient safety and effectiveness outcomes, reducing patient and sponsor burden during long-term follow-up.