The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects

Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inher

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase unders

Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process ai

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess th