(140) The Utility of Data Tokenization for Real World Data (RWD) Access in Clinical Trials

Publication Number: 1185

Background: With the growing abundance of real-world data (RWD) sources, and rapidly evolving use of data technologies, it is important to understand the benefits and risks associated with linked RWD to better understand a patient’s health status, and for individual and population-level healthcare decision-making.

Objectives: Evaluate the utility of anonymized data linking technology using token algorithms to supplement and integrate with clinical trial databases.

Methods: Five (5) Phase II clinical trials have been selected to utilize data tokenization via a token algorithm software to assess the available data sources to be linked to existing patient information collected in the trials. Most token algorithms utilize complete personal identifiable information (PII) including first/last name, date of birth, gender, and address (including zip code). As such, local legal and data privacy considerations must be identified and carefully evaluated. By implementing a token identification (ID) algorithm, PII is transformed into an unrecognizable token ID that is not linkable to the patient.
The data token process and assessment has been initiated in two (2) of the five (5) clinical trials, focusing on a central nervous system (CNS) disorder and on a chronic disease (CD).
As global regulations vary around the collection of PII, only the CNS trial (US only) contained all required PII elements while the CD trial (global in X countries) only contained the patient’s email address. Key to the analysis will be determining the number and type of PII required to maximize the utility of a token algorithm.

Results: Of the 38 patients currently enrolled in the CNS trial to date, all required PII data elements have been available and utilized. To date, the CD clinical trial has enrolled 33 patients with the availability of an email address for all participants. The analysis will provide findings from both clinical trials in terms of the availability of PII and percent linkable with other real-world data sources.

Conclusions: The ability to tokenize trial data in the development lifecycle allows for earlier access to real world data on specific patient populations allowing the ability to possibly validate real world populations prior to marketing authorization. This along with its ability to directly enhance data for clinical trial programs.