Trial Tokenization: Building A Bridge Between Clinical Trial Data And Real-World Data

Randomized controlled trials are the gold standard for scientific research. However, the time, cost and risk of running randomized controlled trials demands innovation.

Life science companies invest billions of dollars each year researching and developing new treatments for patients. Each of these clinical studies is carefully designed to test specific hypotheses about treatment safety and efficacy, which are laid out in the study protocol. Yet for all of this investment, more than 85% of the treatments that are studied in Phase I trials never receive FDA approval.

At such high cost and risk, life science companies have a clear interest in learning as much as they possibly can from each clinical trial that they run. Today, innovation ranges from implementing adaptive clinical trial designs to seeking to replicate the results of clinical trials using real-world data studies. However, the first step to changing how clinical trials are run is surprisingly simple.

Tokenizing data is a straight-forward process that uses the underlying identifying information in a dataset to create a universal, de-identified key that can be referenced to link records across datasets — a Datavant Patient Key.

By tokenizing clinical trial data, life science companies gain the ability to link real-world data to their clinical trial data at any time, without unblinding the study or compromising the privacy of trial participants.

Today, a few early pilots have been run, but there is significant untapped potential.

Whether a company wants to link to electronic health records to run a hybrid trial, pull in diagnostic lab data for retrospective sub-cohort analysis, or look at claims data for long-term surveillance monitoring, it all starts with one simple step: tokenize trial data.