Summary
This technical report evaluates the utility of data tokenization in clinical trials, particularly focusing on the integration of real-world data (RWD) with clinical trial data. It outlines the process of using token algorithms to anonymize personal identifiable information (PII) while linking it to existing patient information. The report details the methodologies employed, including legal and regulatory considerations for informed consent amendments and the implementation of token algorithms by Science 37 and Boehringer Ingelheim. It also presents the results from two Phase II clinical trials, highlighting the number of patients enrolled and the types of PII collected. The findings indicate the potential for improved linkage of real-world data to clinical datasets, which can enhance the overall strategy for real-world evidence. The report concludes by discussing the implications of tokenization in enabling earlier access to real-world data, thereby facilitating better validation of patient populations prior to marketing authorization.
