Monday, May 29, 2023

Final FDA Guidance "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products" - what we learned?

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In May 2023, FDA published the final guidance for industry " Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biolo...
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Sunday, May 21, 2023

Comparing assumptions for sample size estimation with the interim and final results

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Sample size estimation is one of the critical aspects of the clinical trial design. The sample size estimation is usually based on the prima...
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Wednesday, May 17, 2023

Another successful trial with randomized withdrawal design

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Biotech company PTC Therapeutics announced today that their phase III study of Sepiapterin in PKU patients achieved the primary efficacy en...
Monday, May 01, 2023

Violin plot versus Box-Whisker Plot

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A box and whisker plot (Also called: box plot, box-whisker diagram) is defined as a graphical method of displaying variation in a set of da...
Monday, April 17, 2023

Change from Baseline versus Percent Change from Baseline

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The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD)...
Tuesday, April 11, 2023

Obtaining standard deviations from standard errors and confidence intervals for group means

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Sometimes, we need to obtain a standard deviation (SD) in order to calculate the sample size for a new clinical trial where the primary effi...
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Saturday, April 01, 2023

"Ensuring Public Trust in an Empowered FDA" - Accelerated Approval

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 In the latest issue of New England Journal of Medicine , Drs Ross, Berg, and Ramachandran wrote a paper: " Ensuring Public Trust in an...
Saturday, March 11, 2023

Critical Dates after NDA/BLA submission: Filing Date (Day 1), Day 14, Day 60, Day 74, and PDUFA date

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After the NDA/BLA is submitted to FDA, the FDA review clock starts. There are several critical dates relevant to the applicant (the sponsor)...
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