Track 3: Data and Technology
Innovative technologies are improving efficiency in the collection of data from clinical trials through the product development lifecycle to patients. This track focuses on recent developments in clinical data curation, data development, and harnessing data across the product lifecycle which includes the structure, organization, validation, storage, extraction, and delivery of diverse types of patient data to facilitate review, analysis, and reporting in regulatory submissions. Specifically, the track will have the following as focal points:
- Current and innovative methods to evaluate technology advances and systems to support clinical research programs cross-functional management integration, clinical utility, and endpoint development with the use of mobile/digital technology
- Structured and unstructured data sources
- Data Quality
- Blockchain technology and cloud computing
- Data Standards
- Real-World Data / Evidence
- Mobile / wearable technologies
- Informatic solutions and machine learning
- Endpoints: evolving data requirements to support new endpoints
- Data visualization – (ask track)
- DEI – strategies to ensure representative and unbiased data?
DIA recommends this track and associated sessions to professionals involved in: informatics (bio and medical), data standards and quality control (and regulatory standards implementation specialists), data quality, clinical data management, clinical trial design, clinical operations, electronic health records, submissions, and global submissions, health economics outcomes research, biostatistics, medical writing, real-world evidence roles, epidemiology, post-market studies, regulatory affairs and operations, and statistics.
Included Topic Areas
The broad range of data that is generated during biopharmaceutical development, approval, and post-market will be covered in this track including: clinical (including data from electronic health records, wearables, and other mobile apps), and real-world data from large data sets (including registries and national datasets, claims data, and prescription fulfillment. Topics related to bioethical issues in data and technology are also welcome and may be considered for a special track in the meeting.
- Harnessing Real-World Data and Real-World Evidence
- Transformation of the Data Manager to the Data Scientist and Steward
- Technology and Emerging Data Sources
- Data Source Agility and Risk-Based Approaches
- New and Emerging Standards, Guidance, and Regulations Impacting Data, Data Standards, and Technology