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Maximize Clinical Trial Insights Via Patient Tokenization

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The clinical trial landscape remains active, with more than 20,000 studies in the U.S. currently recruiting participants. Of these, many are interventional studies aimed at bringing new therapies to market1

Ensuring trial success presents challenges, particularly when it comes to accessing and leveraging patient data effectively. A partnership between Komodo Health and Datavant offers a solution through patient tokenization, which connects disparate healthcare data across the ecosystem.

Tokenization Bridges Data Silos
Because healthcare data is siloed, it's difficult to capture longitudinal patient journeys before, during, and after clinical trials. However, recent advances in data connectivity and advanced analytics allow real-world data (RWD) to be collected both prior to and for years after a trial. This increased capture helps identify which treatments work, and for whom, in real clinical practice.

Ryan Moog, head of Life Sciences solutions at Datavant, explains the "how" behind this data connectivity: Datavant generates privacy-preserving patient "tokens" — alphanumeric codes that are used to de-identify patient data. Tokens are one-way encrypted and contain no personally identifiable information (PII). Additionally, linked datasets undergo statistical certification to ensure that they remain de-identified and HIPAA-compliant. These tokens enable the linkage of patient health records across datasets while maintaining privacy.

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Combining Clinical Trial Data and RWD 
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 the trial doesn’t capture that are essential to understanding a therapy’s impact.

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Use cases include:

  • Optimizing study design and site selection: Patient tokenization allows sponsors to leverage legacy trial data combined with RWD sources like claims and EHR. This provides insights into cohorts of interest, informing protocol optimization, study design, and site selection for future trials.
  • Enabling external control arms: In rare diseases and oncology, tokenization facilitates the creation of external control arms, reducing enrollment requirements, accelerating timelines, and driving significant time and cost savings. Sponsors avoid having to increase the size of their clinical trials by including a placebo control arm for a deeper and broader understanding of patient behavior, therapeutic benefit, and safety and efficacy.
  • Reducing the burden of long-term follow-up: Linking trial data with real-world sources such as claims data eliminates the need for extensive manual follow-up because patient journeys are continuously tracked. This enables teams to track safety and effectiveness long-term — up to 15 years post-trial. 

Watch our webinar, “The Key to Clinical Trial Success: Patient Tokenization,” to learn more about tokenization in clinical trials, and visit our website to see how Komodo supports Clinical Development teams.

To see more articles like this, follow Komodo Health on XLinkedIn, or YouTube, and visit Insights on our website.

1ClinicalTrials.gov. Trends and charts on registered studies. Accessed 08/24. https://clinicaltrials.gov/about-site/trends-charts

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