FDA receives a vast amount of information from a variety of sources, including product submissions, adverse event reports, de-identified patient data from health care providers, and results from surveys and basic scientific research.
Successful integration and analysis of data from these disparate sources would provide knowledge and insight not possible from any one source alone. A few of the many currently untapped opportunities include:
- Monitoring adverse event trends and disease outbreaks;
- Combining data from multiple clinical trials and postmarket studies as well as preclinical data;
- Evaluating and comparing effectiveness and safety of medical and veterinary products in particular sub-populations, including sex/gender and race/ethnicity analysis, and ultimately host genomics and/or genomic response data; and
- Conducting large-scale active surveillance for rare events and data- and text mining for a variety of research purposes.
FDA is in the early stages of constructing the IT infrastructure necessary for this type of complex data integration, but full realization of the enormous potential in harnessing these diverse data will require extensive improvements to the current FDA IT environment.
Within each FDA Center activities are underway that illustrate the range of possibilities and the potential for benefits to public health that would be obtainable. Expansion, coordination, and improvement of the existing IT infrastructure will enhance and augment these ongoing activities.