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A New Role for Real-World Data in Clinical Trials

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Datavant
January 8, 2024

Utilization of real-world data (RWD) within clinical trials has gained significant traction since the passage of the HITECH act in 2009 and 21st Century Cures Act in 2016. Clinical trial tokenization and de-identified RWD linkage provides sponsors the opportunity to generate previously unavailable insights by linking trial data with diverse sources such as electronic health records (EHRs), patient registries, and claims data. There is no doubt that de-identified linking of RWD to trial data at the patient level is an important long-term evidence-generation strategy. However, in some instances, a patient’s identity is necessary to conduct the day-to-day operations of a clinical trial.

Datavant’s technology powers privacy preserving healthcare data exchange in the largest real-world data ecosystem. A subset of data sources in Datavant’s ecosystem have rights to share identifiable data at the patient level for clinical research purposes. Datavant’s Patient Authorized Workflows enables a sponsor and a selected data partner, each with the requisite legal authorizations and consents, to securely connect identifiable data. This brings the value of data linkage to trials teams, enabling the use of RWD for trial activities, including:

  1. Trial Recruitment: Targeted recruitment and enrollment strategies and matching patients with the most appropriate trial for them.
  2. Clinical Outcome Adjudication: Accurate assessment and adjudication of clinical outcomes, allowing researchers to analyze and validate endpoint data effectively at the site level and within the trial electronic data capture (EDC) system.
  3. Safety Event Detection: Rapid identification of safety events for sponsors ensure patient safety both during the trial and as part of long term follow-up.

Overview of Patient Authorized Workflows

Patient Authorized Workflows, now offered by Datavant, enables the secure exchange of data for use in an identifiable workflow. Utilizing Datavant Connect, a platform for RWD connectivity, sponsors can de-identify and tokenize their identifiable data, find and assess potential data partners, and connect datasets at the individual level while preserving patient privacy. This process of tokenization and linkage, helps minimize the movement of personally identifiable information (PII) and enhance patient privacy. At the point when knowing the patient identity is necessary, the sponsor or data partner would utilize a crosswalk (or passthrough ID) to connect the data with the relevant PII.

Benefits of Patient Authorized Workflows

The implementation of patient-authorized workflows provides a pathway for the use of RWD in the daily activities of conducting a clinical trial. This means the benefits of tokenization and data linkage are not only for future insights by evidence generation teams, but near-term activities by the clinical development and trials operations teams. Specifically, it can help to significantly enhance patient recruitment. By leveraging authorized patient data, sponsors and recruitment vendors can more effectively and efficiently match patients with appropriate trials at the patient level, streamlining the recruitment process. Furthermore, this approach can improve the process of outcome detection. Utilizing comprehensive patient data allows for more precise tracking of overall survival (OS), progression-free survival (PFS), and other key clinical variables at the site level.

Use Case: Trial Recruitment

The use case outlined in Figure 1 is an illustration of the potential practical and impactful application of this workflow for clinical trial recruitment. Specifically, a sponsor is recruiting for a trial investigating the safety and efficacy of an investigational medicine for inflammatory bowel disease (IBD). They are experiencing a high screen fail rate because interested individuals do not have the genetic marker required for enrollment. A patient advocacy group within the Datavant ecosystem that specializes in IBD has a registry through which patients have authorized the use of their data for clinical trial recruitment and consented to be contacted for trial enrollment opportunities. The available dataset includes genetic testing information, but does not contain additional clinical information that is needed to evaluate the necessary inclusion/exclusion criteria needed by the sponsor. Using Patient Authorized Workflows, the Advocacy Group is able to utilize a combination of identifiable claims data as well as their patient registry data to confirm high-level inclusion/exclusion criteria, including diagnoses, medication history, and genetic markers. The selected patients can then be directly contacted about enrollment into the trial. The sponsor finds that the screen failure rate for those patients referred into the trial via the RWD informed recruitment workflow through the Patient Advocacy Group is substantially lower than their original recruitment strategy, helping the sponsor meet their enrollment goals and stay within expected study timelines.

How data flows for trial recruitment through a patient advocacy group
Figure 1

Future Implications and Conclusion

We believe the potential impact of Patient Authorized Workflows on the future of clinical trials is immense. Protecting the privacy of patients and connecting data to enhance the conduct of clinical trials sit squarely within our key pillars of excellence at Datavant. This approach has the potential to significantly reduce the burden on trial teams and sites, helping to enhance the trial efficiency and maintain the high standards of patient privacy required for clinical trials.

Are you conducting or developing a clinical trial that you think may benefit from the linkage of RWD? Contact Datavant today to learn more about the use of both de-identified and identifiable RWD in clinical trials.

LEGAL DISCLAIMER. The information provided herein does not, and is not intended to, constitute legal advice; rather, all information, content, and materials described herein are for general informational purposes only.

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