FDA and Duke-Margolis to Convene Public Meeting on Developing a Real-World Data Ecosystem - Drug Information Update

https://www.fda.gov/drugs/fda-and-duke-margolis-public-meeting-establishing-high-quality-real-world-data-ecosystem-07132020?utm_campaign=FDA%20and%20Duke-Margolis%20to%20Convene%20Public%20Meeting%20on%20Developing%20a%20Real-World%20Data%20Ecosystem&utm_medium=email&utm_source=Eloqua

FDA and Duke-Margolis to Convene Public Meeting on Developing a Real-World Data Ecosystem

The U.S. Food and Drug Administration and the Duke-Margolis Center for Health Policy will convene a virtual public meeting on July 13-14, 2020, to explore potential approaches to developing a high-quality real-world data (RWD) ecosystem. Discussion during the meeting will consider technical challenges and cultural barriers to the scalability of data capture processes, as well as emerging practices being implemented among the stakeholder community. The development of the nation’s health information technology infrastructure provides new opportunities to capture diverse sources of data generated through routine health care delivery and other health-related data sources. However, challenges and questions remain about the reliability of these data for research purposes and for regulatory decisions.  Existing RWD sources primarily collect information for the delivery or reimbursement of health care services. Physicians and other health care providers capture data on their patients’ diseases, including their response to therapies, adverse events, and clinical outcomes; however, these data are often not readily accessible and easily standardized. These limitations make it difficult to share data between the clinical and research settings, representing a lost opportunity to capitalize on data already being collected.   Advancing data capture practices at the point-of-care can enhance RWD quality by reducing the need for data curation and permitting the collection of fit-for-purpose data (i.e., data that meets requirements for the intended use) that addresses key research questions and potentially improves quality of care.  This public meeting will discuss ways to strengthen data collection processes through establishing an RWD ecosystem, including tools, standards, and workflows within and across institutions.  The meeting will be held July 13 from 1-3:30 pm ET and July 14 from 1-4:30 pm ET. Individuals can register here for the meeting or contact Duke-Margolis Events for more information.