Creating a Multiple Chronic Conditions Database
The U.S. Food & Drug Administration wanted to find out whether individuals with multiple chronic conditions are being excluded from controlled clinical trials for new therapeutic products.
Beyond that, the agency asked whether including or excluding these individuals impacts the development of therapeutics that may help reduce U.S. healthcare costs, and offer patients better management of their disease.
For this project, electronic data submitted to FDA on New Drug Applications (NDAs) and Biologic License Applications (BLAs) for 2010 were utilized to evaluate the presence of chronic conditions for subjects enrolled in clinical trials; 147 studies—encompassing 115,342 subjects—met the criteria for inclusion in the analysis.
This graphic shows how Digital Infuzion worked with the FDA to tackle this project:
Digital Infuzion architected, designed, and developed a prototype database.
Now, the FDA’s data pool populates a flexible, reusable database that will enable the agency to perform data analyses across studies.
This database will allow the FDA to conduct future analyses of multiple chronic conditions by adding new information to enrich the sampled data.