Clinical trials remain the gold standard for regulatory decision making in medicine. However, patients who participate in clinical trials continue generating a wealth of real-world data (RWD) in their interactions with the larger healthcare ecosystem before, during, and after a trial. Trial patients’ RWD, such as medical claims, electronic medical records (EMR), registry data, and wearable device data, that are routinely collected in the background can supplement active collection of clinical trial data (CTD) and provide a substantially deeper insight on benefits, risks, and cost of treatments.
The disconnect between clinical trials and RWD is historically caused by patient privacy concerns. This gap delays access to critical efficacy, effectiveness, safety, and utilization data – ultimately becoming a detriment to patients. In recent years, the fragmented nature of healthcare data has prevented a rapid and clear analysis into the impact of “long” COVID-19, or the actual healthcare journey and impact of Vaping-Associated Pulmonary Injury (VAPI). However, 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. These RWD-enhanced CTD more holistically describe the patient’s trajectories, characteristics, and outcomes and help sponsors close critical gaps in evidence generation. With a deeper understanding of patient’s 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.