The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex ...

Observational study designs like cohort, case-control, and cross-sectional are the backbone of epidemiology, but each comes with unique strengths, limitations, and bias risks. Understanding these ...

As biomarker studies employ increasingly complex and expensive genomics and other correlative methods, it is increasingly important to rigorously design these studies and analyze the downstream ...