DIA 2020 Virtual Global Annual Meeting

Component Type: Session
Level: Intermediate

Real world data (RWD) comes from a variety of secondary technology sources, including electronic medical records, payer and consumer data, wearable technology, electronic assessments, and patient portals, covering a very heterogeneous range of data sources to be contemplated when developing clinical data sets to meet regulatory needs. Collecting and converting this data into models for analysis is complex. This session will describe our initiative to test the requirements to create clinical data sets from a representative yet full range of RWD sources, and traditional EDC data, to move toward implementation of new RWD technologies to benefit clinical research. A trial was designed and conducted using data from a variety of sources including electronic medical records, patient reported outcomes, wearables, labs and EDC data. Dataset development and derivation was tested completely through tables, listings and figures creation and analysis. In keeping with the proof-of-concept objective, the analyses were not intended to demonstrate statistically or clinically relevant results, but instead to ensure that analyses could be successfully performed on the clinical data set. Attendees will understand how real-world data can be leveraged, integrated and analyzed in the context of the clinical research needs of the life sciences industry.

Learning Objectives

Translate real world data (RWD) needs into meaningful clinical research designs; Describe how to to use tokens in RWD-enabled clinical research to protect patient privacy; Describe how existing processes used to meet Good Clinical Practice (GCP) requirements must be evaluated and adapted to go beyond what is used today for Electronic Data Capture (EDC).

Chair

Keith Wenzel

Speaker

Results from a Proof-of-Concept Study to Demonstrate the Integration of Five Real-World Data Sources with EDC
Keith Wenzel

Real World Data Combined With Powerful New Technologies is Disrupting How Clinical Research is Done
Jeff Elton, PhD, MBA