A Tokenized Approach: The Future of Clinical Trials

Real-world data (RWD) has become an essential resource driving clinical research. Connecting health data from sources outside of clinical trials (such as electronic health records, clinician notes, claims, etc.) provides a broader understanding of therapeutic areas and a more complete understanding of patient journeys. 

But the use of RWD comes with strict privacy requirements. How do life science organizations tap into patient-specific data without sacrificing patient privacy?  

Increasingly, the answer is tokenization. By replacing personally identifiable information (PII) with unique random codes, researchers have a viable path to accurately link real-world patient data without compromising confidentiality.

Tokenization Basics

Tokenization transforms PII elements — first name, last name, gender, date of birth, zip code — into a unique identifier. That “token” itself has no meaningful value, but deidentifies PII in a uniformed way, keeping it inaccessible to unauthorized parties. 

With tokenization, a unique code or key facilitates the linkage of disparate de-identified datasets. By matching tokens, researchers can link data across a patient’s record in various data sets, gaining a detailed history without exposing PII.  

The application of RWD in clinical development offers benefits from improving study design to shortening the time-to-evidence cycle for payer discussions. By linking clinical trial data and RWD, tokenization allows for enhanced baseline demographics, supplemental outcomes measures, and post-trial safety and efficacy monitoring without placing additional burdens on sites or patients.

But the integration of clinical trial data with RWD demands thoughtful consideration.

Gaining comprehensive stakeholder support, with a clear understanding of the studies objectives and benefits is critical. It’s important that everyone understands the potential value of linking data early on, so organizations can implement data-linking operational considerations into the study design, particularly from phase II studies onwards.

Experience with RWD

Verana Health has tokenized 90M+ patients in 70+ electronic health record (EHR) systems from over 20K clinicians across our Ophthalmology, Urology, and Neurology medical registries. 

When combined with a partner’s RWD, the dataset creates a unique multi-modal view, with valuable information about the longitudinal patient journey, healthcare utilization, and costs. 

This expansive perspective enables life sciences organizations to assess patient burden, disease progression, healthcare resource utilization, and patient socioeconomic and demographic data. 

Capturing clinical data before, during, and after a trial enables researchers to obtain a greater breadth and depth of information. RWD fills in missing insights that a trial doesn’t capture but are essential to understanding a therapy’s impact.

Applied to clinical trials, the tokenization of RWD allows study sponsors to take significant steps to improve trials with actions including: 

• Optimize study design and site selection
• Enable external control arms (ECAs)
• Reduce the burden of long-term follow-up
• Improve interpretability and generalizability 

In practice, the application of tokenization and the integration of diverse datasets significantly enhances the comprehension of treatment pathways and patient outcomes. 

These advancements point toward a future where novel data integration drives more complete and representative clinical insights.

Looking to the Future 

The integration of clinical trial data with RWD through tokenization represents a significant leap forward. By ensuring patient privacy and facilitating the linkage of diverse datasets, researchers can unlock invaluable insights into patient journeys, treatment outcomes, and healthcare utilization.

As Robert Zambon, Vice President, Product, at ConcertAI summarized, “The insights this enhanced data provides are helping the industry reach a synergy between R&D and commercial throughout the development lifecycle. It’s accelerating timelines, laying the groundwork for new assets, and bringing much needed therapies to market while providing unique value to both sponsors and patients.”

Learn more: Bridging the Patient Journey with Real-World Outcomes Using Tokenization