CITC 2024 – D1S02 – Basics of Clinical Trial Design

Описание: Learn the essential principles behind rigorous clinical research that supports FDA drug approvals. This video covered the key elements that make clinical studies reliable and scientifically sound, including what makes a study "adequate and well-controlled" according to FDA standards. Explore why control groups are critical for determining drug effectiveness, examine different types of controls used in clinical investigations, and discuss proven methods researchers use to minimize bias and ensure objective results.

Timestamps

00:34 – Adequate & Well-Controlled Studies

05:33 – Purpose of Control Groups

18:13 – Methods of Assignment to Study Arms

23:03 – Measures to Reduce Bias

27:37 – Assessing Response / Endpoints

32:53 – Intercurrent Events

43:22 – Other Design Considerations

47:49 – Summary

Speaker:

James P. Smith, MD, MS
Director
Office of New Drug Policy (ONDP)
Office of New Drugs (OND)
CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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