DIA 2020 Global Annual Meeting

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.