CITC 2024 – D1S03 – Statistical Principles for Clinical Development

Описание: Explore the essential statistical concepts that form the backbone of reliable clinical research. This video breaks down fundamental principles including bias, variability, and multiplicity, explaining how these concepts impact the validity of study results. Examine how proper understanding of statistics guides researchers in designing robust studies, conducting investigations effectively, and analyzing data to draw meaningful conclusions that support regulatory decision-making.

Timestamps

01:07 – Review of Good-Study Principles

04:51 – Variability v. Bias

08:09 – Variability, Z-statistic, Sample Size, and Multiplicity

18:04 – Bias Types, Sensitivity Analysis

38:57 – Summary

Speaker:

Mark Levenson, PhD
Acting Deputy Director
Office of Biostatistics (OB)
Office of Translational Sciences (OTS)
CDER | FDA

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

-----------------------

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accoun...
SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...  
SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...  
SBIA LinkedIn -   / cder-small-business-and-industry-assistance  
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter -   / fda_drug_info  
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367