Patrick J. Heagerty, PhD
Professor, Department of Biostatistics, University of Washington
Jacqueline Corrigan-Curay, JD, MD
Director of CDER’s Office of Medical Policy (OMP)
U.S. Food and Drug Administration (FDA)
Joshua C. Denny, MD, MS, FACMI
Chief Executive Officer, All of Us Research Program, NIH
Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions
Electronic health records; Real-world evidence; RWE; Real-world data; RWD; FDA; All of Us; Phenotypes; Regulatory; Fit-for-use data; Digital heath
- To create quality clinical/research records, we must design for multiuse by integrating standards-based tools in the EHR to bring together health care and research.
- Quality real-world evidence cannot be built without quality real-world data. With greater efficiencies in data capture, randomization with real-world data provides a pathway for reliable—and persuasive—real-world evidence.
Patient-generated health data is part of FDA’s MyStudies Application, designed to facilitate the input of real-world data directly by patients, which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies, and registries.
In assessing data quality we can ask, How does a data element travel from clinical care to a research data set?
The NIH’s All of Us program is building a diverse database that can inform thousands of studies on a variety of health conditions.
The All of Us study is tracking COVID-19 in its patients. Sites have identified their COVID-19 participants and relevant labs. Consent is obtained for future sharing of data.