Linking Clinical Trial Data with Real-world Data: Powering the Next Generation of Clinical Trial Data Management Software

Sponsors know that access to compelling and relevant evidence across the experimental and real-world is crucial to drug development, safety monitoring, and the improvement of patient outcomes. Unfortunately, a data silo exists that results in loss of time, suboptimal insights, and an increased burden to sites, patients, and sponsors. The linking of clinical and real-world data (RWD) lets sponsors power the next generation of clinical development and accelerate evidence generation activities, including understanding patients lost to follow-up, post-market surveillance, and long-term outcome tracking.

Understand Patients Lost to Follow-Up in Clinical Trials

A missing piece in the clinical trial cycle is understanding what happens to patients who dropped out of a trial. Real-world data can fill this gap by tracking the patient's journey after drop-out. Data linkage lets clients understand the full patient journey and track outcomes, which better informs trial design and success.

Post-Market Surveillance

Post-authorization safety monitoring and post-market surveillance are critical to fully understand the efficacy and safety profile of therapies. This often involves burdensome follow-up visits for the patients and investigators, but linked clinical trial data and real-world data enables enhanced monitoring and the ability to capture safety signals earlier.

This is especially relevant for shorter-duration COVID-19 trials, where the confines of a clinical trial prevent the longer-term monitoring of safety and efficacy. This is where RWD linkage can help, meeting regulatory requirements for long-term monitoring and safety surveillance. Linking clinical and real-world data has allowed for tracking of long-term efficacy, durability, and subpopulation analysis for COVID-19 therapies. This lets investigators monitor unexpected signals as they happen and dimensionalize efficacy. Using a data linkage solution, the regulatory requirements for long-term monitoring and safety surveillance critical for vaccine development can be met while reducing patient and site burden.

Capture Longer-Term Clinical Trial Outcomes

Longer-term patient outcomes or health resource utilization variables, which are critical to support payor and provider discussions, are often not captured within the finite period of the clinical trial. Typically, a one- to three-year follow-up is needed for RWD to accumulate to generate this evidence, but conducting data linkage for clinical trial patients can accelerate this.

Osteoarthritis and rheumatoid arthritis trials are often short in length and can focus on patient-reported outcomes and structural endpoints. Analyzing real-world data of patients post-trial helps investigators understand patient functionality and productivity, such as delay of joint replacements, hospitalization, and long-term activity levels. This gives a fuller picture to support payor and provider discussions.

These are just a few examples of what clinical trial data linked with real-world data can do. To perform data linkage at scale, you need a robust solution that is centralized and scalable. Medidata Link provides this solution agnostic to CRO, token vendor, and consent method. In addition to patient linkage, Medidata Link leverages extensive analytics expertise in clinical and real-world data on a privacy-certified environment complete with open-source tools. The Medidata team helps sponsors accelerate evidence generation activities seamlessly with advanced analytics throughout a trial.

Learn more about how Medidata Link can connect your clinical and real-world data.