Tag Archive for: validation

The healthcare industry currently generates about 30 percent of the world’s data volume and that number is expanding rapidly, reaching an annual growth rate of 36 percent by next year. The life sciences are a major contributor to the expansion of the healthcare industry’s data, with a market growth rate of 11 percent up until 2032. In particular, drug development and monitoring continue to expand as the volume of information and variety of sources used in data collection increase. Organizations are now challenged with not only gathering and collecting data but also validating potential safety events.

Roche and Eli Lilly are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval.

In December 2021, the FDA issued draft guidance to lifescience researchers on evaluating EHR and claims data in studies to support regulatory decisions. This new draft guidance covers using real-world data from these sources to support regulatory decisions on both safety and effectiveness.