In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to show the effectiveness of a new drug. The guidance, ...

Consistent with the Food and Drug Administration’s (FDA) commitment to streamlining the prescription drug and biologics approval processes by adopting innovative approaches to clinical trial design, ...

Precision oncology exploits genomic, immunologic, and other biomarkers to drive discovery, drug development, and clinical care for patients with cancer. Precision oncology helps devise individualized ...

Cluster randomized trials (CRTs) represent a pivotal design in evaluating public health and clinical interventions where individuals are grouped into clusters (such as schools, hospitals or ...