In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to show the effectiveness of a new drug.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, ...
The FDA's move to incorporate Bayesian statistical methods into clinical trials of drugs and biologics garnered special treatment in JAMA this week. JAMA published three perspectives -- two welcoming ...
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, ...
Cluster randomised trials assign groups of individuals—such as schools, clinics or communities—to intervention arms rather than randomising participants individually. This design acknowledges that ...
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