Monday, February 28, 2022

Human Preclinical Studies and Phase 0 Clinical Trials

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The drug development process includes various steps from discovery (discovery of a new compound or biological product) to preclinical resear...
4 comments:
Tuesday, February 08, 2022

FDA's Priority Review Voucher for COVID-19 Vaccine

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 To spur drug development in the under-developed area, FDA relies on various policies and programs to incentify the biotech and pharmaceutic...
2 comments:
Tuesday, February 01, 2022

Randomization, Re-Randomization, and Micro-Randomization

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 I recently saw a Twitter post mentioning " Micro-Randomized Study Design Example - Maryland Alcohol-Dependent Moms Abstinence (MAMA) S...
Monday, January 17, 2022

Paired T-test and McNemar's test for paired data based on the summary data

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Sometimes, it is necessary for us to calculate the p-values based on the summary (aggregate) data without the individual subject level data....
1 comment:
Sunday, January 09, 2022

Overrunning issue at the interim analysis for group sequential design

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It is pretty common these days that clinical trials (especially the late phase, adequate, and well-controlled studies) employ interim analys...
1 comment:
Saturday, January 01, 2022

Futility Analysis and Conditional Power When Two Phase 3 Studies are Simultaneously Conducted

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In late-phase clinical trials, an independent Data Monitoring Committee (DMC) is usually set up. If the clinical program includes multiple l...
Monday, December 27, 2021

Futility Analysis and Conditional Power

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Adaptive design has been used to drug development programs more efficient. According to FDA's guidance  Adaptive Designs for Clinical Tr...