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FEATURED ARTICLES
No Surprise Here: Experts Value Clinical Relevance Over Statistical Relevance
Experts weighed in: “Agree or disagree? Statistical significance is preferable to clinical relevance.”
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Mock Inspection Advice From Former Regulatory Investigator
Former FDA investigator Alia Legaux, D.H.Sc., runs through her top tips for running a mock investigation.
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The Hidden Work That Keeps AMC Trials Moving
After a chance LinkedIn connection led to a conversation with Paul Antaby of MD Anderson, I got an inside look at how clinical trials really operate inside a major academic medical center. From material transfer agreements and data governance to recruitment, scale, and CRC burnout, this interview reveals the hidden work that keeps AMC trials moving — and why they operate so differently from community sites.
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FDA Further Expands And Clarifies Expanded Access FAQs
Healthcare attorney Dianne J. Bourque breaks down the FDA's October 2025 update to its Expanded Access FAQs.