Clinical Trials Users Digital Technology Forum

Implementing Standards for Technology and Data Enabling DCTs

The user’s technology forum will present pragmatic and in-practice uses of digital technologies enhancing clinical trials operations and processes. Presentations will be led by users and adopters of the technologies to highlight learnings and challenges in the integration to their clinical trials and research processes. The Forum is designed to explain how users may best evaluate these technologies from not only a regulatory lens but those technologies following global technical and ethical standards in their design and development. The forum will feature both "integration case study" sessions, presentation from regulatory and patient representatives, hands-on pseudo-standard working group discussions and development of frameworks for where more work is needed for trust and adoption of these technologies. 

Clinical Research Technology/Application include but not limited to:

• Wearables, sensors and other connected devices for continuous monitoring 

• Digital Therapeutics applications supporting eCOA (Electronic Clinical Outcome Assessments), televisits, screening and more

• Artificial intelligence (AI) and machine learning (ML) for advanced and predictive analytics on patient retention rates, analyzation and implementation of participant, patient recruitment, filtering unstructured patient data and more

• Data science in clinical trials – understanding the patients, purpose, processes, and platform

• Blockchain/distributed ledger technologies (DLTs) for patient recruitment, data integrity, and clinical trial supply chain 

The Forum is supported by the following IEEE incubation and standards working groups including: 

• Technology and Data Harmonization For Enabling Decentralized Clinical Trials Incubator Program; 

• IEEE P2418.6 Standard for the Framework of Distributed Ledger Technology (DLT) Use in Healthcare and the Life and Social Sciences Working Group;

• IEEE P2968.1 &.2: Trial Use Recommended Practice for Decentralized Clinical Trials Patient Safety

• IEEE P2933: Standard for Clinical Internet of Things (IoT) Data and Device Interoperability with TIPPSS