The Growing Momentum and Adoption of Trial Tokenization in 2023 and Beyond

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February 2, 2023

Advancing the Mission of Datavant Trials

When Datavant launched our original clinical trial offering in late 2019, we had the conviction that linking prospectively-collected clinical trial data with an ecosystem of real-world data (RWD) could dramatically improve trial sponsors’ ability to understand the complete patient journey of their study participants. We believed that uniting clinical trial data and real-world data via privacy-preserving record locators, otherwise known as tokens, could better inform evidence generation, accelerate the development of new treatments, improve drug safety and efficacy, and empower the healthcare industry to more effectively tackle complex diseases.

We’ve been thrilled by the early progress towards this ambitious goal. As we kick off 2023, I wanted to share some reflections with the Datavant community about the growing momentum and adoption of trial tokenization, as well as demonstrate our recommitment to the market to drive clinical trial innovation, develop new use cases, and educate industry stakeholders.

Growing Acceptance of Tokenization

As of the end of 2022, trial tokenization is now embedded in over 80 clinical trials across dozens of sponsors and thousands of clinical trial sites, with over 100,000 patients participating in these trials. Sponsors have seen the value of adding tokenization to studies of all shapes and sizes, from small, early-phase rare disease studies with only a few dozen patients who may have a very disjointed diagnostic odyssey, to large Phase III programs with tens of thousands of enrolled patients. Below is one real-world example of a sponsor able to find 85%+ overlap using tokens of 124 participating patients in a small clinical trial with claims and EHR data in the Datavant RWD partner ecosystem. With the recent availability of new Assess tools, we are making the overlap process of finding tokenized trial patients in the RWD ecosystem even faster.

Some study sponsors are now generating trial tokens for the majority (and, in some cases, all) of their new clinical trial protocols. This allows sponsors to have a consolidated approach to patient consent, site engagement, and technology strategy – as well as supercharge the utility of linkable data assets and data platforms they are working on across clinical development teams and therapeutic areas.  To read more about the use cases these sponsors are investing in, check out Datavant’s recently published eBook on clinical trial use cases.

Additionally, we’ve seen our technology embedded in many major clinical trial software systems used by sponsors, CROs, decentralized trial companies, and clinical research sites. We are pleased to continue growing the network of partners. Today, Datavant is working with 7 of the leading CROs and has over 15 trial tokenization enablement partners who can support simplification of the patient tokenization process. We will continue to grow this landscape of partners to ensure sites, sponsors, and patients can participate in the tokenization process as seamlessly as possible.

Commitment to Clinical Trial Innovation

In September 2022, we expanded Datavant Trials to include our web-based tokenization platform for sites. We’ve now seen this platform successfully deployed in several studies and rapidly accepted by sites as a straightforward and secure way to process PII for the creation of trial tokens. Datavant Trials also included new study dashboards that allow sponsors to track clinical site tokenization progress in real time. These capabilities are now available to any of our Datavant Trials clients.

Earlier this month, Datavant was awarded US Patent #11,550,956 for trial tokenization and the creation of the bridges required to link between trial data and real-world data. We are committed to open innovation in this space. Trial sponsors need the flexibility to pick the best-of-breed fulfillment, data, and analytics partners. That goes beyond tokenization, and includes accessing valuable sources of real-world data from partners capable of delivering those insights. We remain absolutely committed to being a neutral partner with any clinical trial stakeholder in the industry to break down clinical development data silos.

Finally, as detailed in our recent announcement of Datavant Switchboard for Medical Record Retrieval, we are eager to bring our record retrieval capabilities to streamline patient-consented and patient-directed release of medical information. While recent regulations in the US, like the 21st Century Cures Act, have empowered patients to control the release of their medical records, the process of actually completing that request is still arduous and time-consuming for patients, sites, and sponsors. Datavant’s Switchboard for Medical Record Retrieval combines technology and services to simplify this experience for all parties, while ensuring that any use of patient data is tightly controlled and secured. These capabilities are particularly exciting for study recruitment as well as trials that require rapid and direct confirmation of patient eligibility. Expect to hear more in 2023 on how we also bring capabilities like this to support clinical trial data connectivity outside of the US, as well!

Connecting with Datavant Trials in 2023

Along the journey of growing our impact in clinical trials, we’ve recognized the importance of being agents of education in the market. Tokenization and linkage to real-world data are new paradigms for sites, sponsors, and some regulators. As a new model for generating longitudinal patient data, we have a responsibility to convene industry stakeholders to share best practices and lessons learned.

In 2022, we began hosting a series of regional Trial Tokenization Workshops. These events are single-day, multi-sponsor events intended to create a collaborative environment for sponsors to share updates from the front lines of tokenized trials. In these sessions, participants have an opportunity to share their perspective on strategies for handling patient consent, incorporating RWD linkage into protocol language, or selecting data sources for specific therapeutic areas and clinical endpoints. They also serve as a venue to convene the industry to consider ways to better educate regulators, patients, and sites on the value of linked data before, during, and after clinical trials. These workshops have been a great place to exchange ideas and accelerate use cases these stakeholders are pursuing. As one sponsor leader shared with me at our New York workshop “it was wonderful to dig into topics like consent and matching – these discussions will help me accelerate our exploratory work by 6 months; we look forward to the next one!” We’ll be hosting several more of these in 2023, but if you would like us to host a workshop in your area – let us know!

We will also have a speaking presence at many major US clinical trials and life sciences events in 2023. If you’ll be at SCOPE (February 6-9, 2023; Orlando, FL), ISPOR (May 7-10, 2023; Boston), MAGI East (May 21-24, 2023; Philadelphia) or the DIA Global Annual Meeting (June 25-29, 2023; Boston) please let us know! We would love to meet in-person to discuss and explore your use of more complete patient data. From there, we can identify how to best work together towards accelerating innovation in drug development and bettering patient outcomes together.

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