Clinical Data – Gearing for a future of: Real-Time Data Review

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management.

The Clinical Data landscape has evolved significantly over a period of time, increasing in both complexity and volume. With early adoption of emergent technologies, this session delves into re-thinking the Clinical Data flow design from current architectures into future that will enable us inch closer to a real-time data review which may soon become a necessity due to the variety of data sources introduced rapidly. We saw the last few decades where “Third party” like Imaging/ Omics/ Lab data had surpassed the traditional EDC data in volume of a Clinical Trial. We are heading to a data explosion with potential elements of continuous monitoring in future Clinical Trials, using data streams as input from Devices.

This new paradigm introduces expanded scope with respect to Data Cleaning in a traditional sense – where we may have to go beyond “Edit Checks” – Including Checks for identifying/ pre-empting network errors in data streams and detect device malfunctions as a malfunction has could even become a reportable adverse event in certain circumstances. While some aspects of the perceived real-time monitoring have comparable precedence such to other Industries (Eg: real time “Banking Transaction call”), some are very unique to Healthcare Industry. Increasing Data Interoperability, while opens doors to more possibilities also reiterates focus on patient data safety with increased access. One such example on data interoperability is the to HL7 FHIR to CDISC Joint Mapping Implementation Guide in 2021.

This session will focus on how to prepare for the exciting challenges and opportunities in the future of Clinical Data landscape.