Real-world evidence (RWE) is being increasingly used alongside clinical trials to guide biopharmaceutical product development and inform healthcare and regulatory decisions. Because it reflects patients' experience beyond the experimental/clinical trial setting, RWE complements clinical trial evidence by offering invaluable real-world perspectives and providing a more comprehensive understanding of the patient's health journey.

Rapidly evolving advancements in data technology and analytics have been making great strides to enhance the depth and breadth of real-world data, supporting a broader role of RWE across the product development lifecycle. An example includes the linkage of individual-level data across data sources through the use of tokens, or encrypted patient-specific unique identifiers typically created by third-party organizations (e.g.; Datavant, HealthVerity, Komodo, LexisNexis). Tokens do not contain protected information and are designed to be irreversible so that re-identification of patients is not allowed. Research efforts leveraging real-world data tokenized across various sources by HealthVerity at the onset of the COVID-19 epidemic provided critical information on COVID-19. The use of tokens to link patient-level health data across disparate sources is a relatively new strategy of great untapped potential and promise. Conceptually, data tokenization could provide richer real-world data at scale by offering visibility into patient-level information typically not available or not optimally captured in most single large real-world data sources, including molecular biomarkers, ‘omics,’ laboratory data, and data on social determinants of health. Further, data tokenization could be used to link clinical trials and real-world data without compromising the privacy of trial participants.

Demonstration projects are still underway and continuing research and experience in this area will provide greater insight into the value, challenges, and opportunities of tokenization to enhance information on the benefit-risk assessment of biopharmaceutical products.

In this Research Topic, Frontiers in Drug Safety and Regulation will feature key pieces focusing on tokenization of health data to enhance pharmacovigilance and pharmacoepidemiology.
We welcome submissions of reviews, opinions, and primary research articles.

Conflict of Interest Statement:
Topic Editor Dr Simone Pinheiro is employed by AbbVie company.
Topic Editor Dr Alexander Liede is employed by AbbVie company.
Topic Editor Prof. Stanley Edlavitch declares no competing interests with regard to the Research Topic subject.

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