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In Session 5: Statistical Methods for Futility Monitoring, four presentations discussed statistical methods of futility monitoring using group sequential designs and Bayesian statistics.nDr. Michael Proschan at NIAID gave the audience of brief review of different methods for monitoring a clinical trial for futility, including conditional and unconditional power. He discussed the likelihood of stopping a trial that would have reach statistical significance if it was not stopped, and the impact of

Biostats Workshop: Statistical Methods for Futility Monitoring

⏲ 68 min 4 sec ✓ 14-Dec-2023

U.S. Food and Drug Administration

Why it’s cool to be a statistician at FDA

⏲ 2 minutes 12 seconds 👁 1.3K

U.S. Food and Drug Administration

FDA's Sentinel Initiative - Pharmacovigilance 2020

⏲ 54 minutes 27 seconds 👁 1.5K

Turns out the best way to clean your fruits and vegetables of dirt and pesticides may actually be easier than buying an expensive produce wash.

Avoiding Pesticides on Produce is Easier Than We Thought

⏲ 1:0 👁 19.6M

UAB School of Public Health

BST Seminar | Biostatistics at the FDA | UAB School of Public Health

⏲ 48 minutes 2 seconds 👁 23

Alexander Schacht

RWE and the FDA (Part 1) - The Effective Statistician - in association with PSI

⏲ 35 minutes 35 seconds 👁 9

Malaysia's gross domestic product (GDP) grew at a rate of 4.2% in the first quarter of 2024, an increase from 2.9% growth in the preceding quarter as the economy was bolstered by strong private expenditure and a positive turnaround in exports.<br/><br/>During the press conference of the first quarter 2024 gross domestic product figures on Friday (May 17), Chief Statistician Malaysia Datuk Sri Dr. Mohd Uzir Mahidin reported that the growth was higher than the 3.9% year-on-year increase put forward in an advance estimate by the National Statistics Department as well as in a Bloomberg survey of economists.<br/><br/>Read more at https://tinyurl.com/4dbj8svx<br/><br/>WATCH MORE: https://thestartv.com/c/news<br/>SUBSCRIBE: https://cutt.ly/TheStar<br/>LIKE: https://fb.com/TheStarOnline

Malaysia's economy grows 4.2% in 1Q, beating expectations

⏲ 3:6 👁 2.8M

Bay Bridge Bio

Analyzing FDA's statistical review of a Phase 3 program

⏲ 25 minutes 59 seconds 👁 487

U.S. Food and Drug Administration

Understanding FDA Inspections and Data

⏲ 1 hour 56 minutes 15 seconds 👁 4.5K

This presentation provides an overview of the High Throughput Truthing (HTT) project. The HTT project aims to develop a dataset of slides, images, and measurements of a quantitative prognostic biomarker fit for a regulatory purpose. The context is breast cancer, the biomarker is the density of stromal tumor-infiltrating lymphocytes (sTILs) in hematoxylin and eosin-stained invasive breast cancer specimens, and the purpose is to validate computational models. We discuss the results of a pilot stud

Developing a dataset to validate computational models that analyze digital pathology images to assess TILs in breast cancer

⏲ 33 min 60 sec ✓ 05-Nov-2022

Reed Tech Life Sciences

US FDA GUDID Statistics-UDI Submissions by Device Class

⏲ 4 minutes 7 seconds 👁 64

Regis Technologies, Inc.

FDA 505(b)(2) Applications Seminar Part VI: Recent Statistics on 505(b)(2) NDAs

⏲ 5 minutes 32 seconds 👁 149

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