Presentation (CTI)

OBJECTIVES: A major barrier in interventional and observational clinical trials is the fragmentation of participant data across disparate healthcare entities, leading to record gaps and losses to follow-up after any site-based interventions are complete. The ICEBERG study aims to validate a new methodological approach: utilizing patient right of access pathways (the legal right of patients to obtain copies of their health information) to collect comprehensive RWD. The primary objective is to characterize the scope, detail, and completeness of combining EHR and claims data via patient right of access, establishing a robust infrastructure for longitudinal clinical data.
METHODS: This methodological study recruited N > 200 volunteers of varying demographic and clinical backgrounds to demonstrate the benefits and possible limitations of a patient right of access data collection platform over two dimensions.
RESULTS:

Data Acquisition: Assessed the operational feasibility of bypassing traditional site-based collection by using APIs and centralized offline methods to collect raw clinical data over an extended longitudinal window, including up to 5 years of retrospective history, directly from payers and providers.

Data Completeness: Quantified the 'completeness gap' between comprehensive claims data and site-based EMRs, focusing on key parameters often missed in traditional datasets. We measure the capture rate of clinical parameters often missing from single-site research records.

CONCLUSIONS: The ICEBERG study seeks to refine the methodological infrastructure for prospective clinical research by validating a scalable, participant-centric approach to data collection. By demonstrating the ability to construct a complete, longitudinal clinical picture without relying on site-specific resources or ongoing efforts by research teams or subjects, this research identifies an efficient pathway to improve the completeness and longitudinal extension of data available for clinical evidence generation and long-term safety monitoring.